Frost Et Al 2016 the Ethical Inclusion of Children With Psychotic Disorders in Research Recommendations for an Educative Multimodal Assent Process

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Ethics & Behavior

ISSN: 1050-8422 (Print) 1532-7019 (Online) Journal homepage: http://www.tandfonline.com/loi/hebh20

The Ethical Inclusion of Children With PsychoticDisorders in Research: Recommendations for anEducative, Multimodal Assent Process

Katherine H. Frost, Sarah Hope Lincoln, Emily M. Norkett, Michelle X. Jin, Joseph Gonzalez-Heydrich & Eugene J. D’Angelo

To cite this article: Katherine H. Frost, Sarah Hope Lincoln, Emily M. Norkett, Michelle X. Jin, Joseph Gonzalez-Heydrich & Eugene J. D’Angelo (2016) The Ethical Inclusion of Children With

Psychotic Disorders in Research: Recommendations for an Educative, Multimodal AssentProcess, Ethics & Behavior, 26:2, 163-175, DOI: 10.1080/10508422.2015.1063425

To link to this article: http://dx.doi.org/10.1080/10508422.2015.1063425

Accepted author version posted online: 06Aug 2015.Published online: 06 Aug 2015.

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ETHICS & BEHAVIOR, 26 (2), 163–175

Copyright © 2016 Taylor & Francis Group, LLC

ISSN: 1050-8422 print / 1532-7019 online

DOI: 10.1080/10508422.2015.1063425

The Ethical Inclusion of Children With Psychotic Disordersin Research: Recommendations for an Educative,

Multimodal Assent Process

Katherine H. Frost

Department of Psychology

Binghamton University

Sarah Hope Lincoln

Department of Psychology

Harvard University

Emily M. Norkett

Department of Psychiatry

Boston Children’s Hospital

Michelle X. Jin

Department of PsychologyPeking University

Joseph Gonzalez-Heydrich and Eugene J. D’Angelo

Department of Psychiatry

Boston Children’s Hospital and Harvard Medical School

This article addresses the issue of properly assenting children with psychotic disorders to participate

in clinical research. Due to the protective concerns with such a vulnerable population, additional

precautions are necessary to ensure that youth with psychotic disorders assent to research withan appropriate level of understanding regarding study procedures. Current literature suggests that

positive/negative symptoms and minor cognitive deficits do not interfere with the ability to compre-

hend study-related information for adults with psychosis if the study information is presented through

an educative process. Similarly, youth benefit from repeated presentation of procedures and periodic

assessment of their comprehension. An integrated educative process is proposed that emphasizes the

importance of an interactive consent through repetition and participant/investigator feedback.

Keywords: child assent, ethics, psychosis

Correspondence should be addressed to Eugene J. D’Angelo, Department of Psychiatry, Boston Children’s Hospital,

300 Longwood Avenue, Boston, MA 02115. E-mail: [email protected]

mailto:[email protected]:[email protected]


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164 FROST ET AL.

The capacity for children to fully comprehend research and subsequently assent to participation

with full understanding is a key issue of concern for investigators. Currently, most assent proto-

cols use a two-step process: (a) obtaining consent from a parent/legal guardian, which permits thechild to participate in the study, and (b) securing the agreement of the child (i.e., assent) to partici-

pate provided that he or she is judged capable to assent by the investigator (American Academy of

Pediatrics Committee on Bioethics, 1995). If parental or guardian permission has been obtained,

the investigator must then ascertain that if children do assent, their agreement to participate is

voluntary and is given with maximum comprehension of the study. In this context, the assenting

process needs to provide the opportunity for the child to be freely willing to agree or to decline

participation in the study. Specifically, assent is not limited to a child’s acceptance of or failure to

object to the offer to participate in the study by an investigator but should include a clear under-

standing that she or he may freely decide to decline without any repercussions. This voluntary

choice goes beyond an initial agreement (assent) to participate to the “sometimes implicit andsometimes explicit agreement to continue participation on the basis of an understanding of one’s

right to withdraw” (Institute of Medicine, Committee on Clinical Research Involving Children

[IOM], 2004, p. 148).

Schizophrenia and other forms of psychotic disorders are recognized as resulting in significant

long-term impairment and burdens on patients, their families, and the greater society. At present,

psychoses rank in the top three most disabling conditions worldwide (Murray et al., 2012). These

disorders are considered to be neurodevelopmental in nature, hence the critical importance of

enrolling children with or at risk for psychosis into research studies (Kumra et al., 2000). These

children’s participation in clinical research has the potential long-term benefit of expanding the

understanding of early psychosis and the possibility of mitigating the devasting consequences

of such disorders. Therefore, ensuring that youth with severe emotional, behavioral, and cogni-tive problems have the capacity to give informed assent is a critical issue for researchers who

work with these children (Cassetta & Goghari, 2015). The ability to provide informed assent

is a unique concern for youth with psychotic disorders, as they are considered more vulnerable

by virtue of both their age and diagnostic status. However, previous research with adults with

psychotic disorders suggests that psychosis does not definitively impair an individual’s ability

to competently consent to participate in research. Previous studies have demonstrated that the

consenting process in adults experiencing a psychotic disorder can more effectively ensure par-

ticipant comprehension when done as an educative procedure (e.g., a teaching process coupled

with questions, feedback, and repetition) that is combined with reminders of the voluntary nature

of the research. (Eyler, Mirzakhanian, & Jeste, 2005; Misra, Socherman, Park, Hauser, & Ganzini,

2008; Moser et al., 2006). Thus, creating understanding of research and voluntarism for potential

participants takes more than simply providing information or preparing clear consent forms; it

requires a thoughtful two-way process of ongoing communication (IOM, 2004).

To date, there have been no investigations examining the capability of children with psychosis,

or disorders with active psychotic features, to knowledgeably assent to research. However, studies

of healthy children’s ability to assent suggest that engaging with and educating child participants

about the research is necessary to explain the study in a way that they might understand (Lambert

& Glacken, 2011). Thus, taking into consideration the effectiveness of the former educative con-

sent process with adults with psychosis, a similar assent process with children will likely increase

their comprehension of study procedures and ultimately allow them to provide a fully informed

and freely made decision about participation. An educative assent process also has the possibility


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AN EDUCATIVE, MULTIMODAL ASSENT PROCESS 165

of benefits beyond the actual research. Because medical researchers are perceived by patients and

families as part of the medical establishment, the educative assent process can improve the child

and family’s experience of participating in research and, by doing so, enhance feelings of trustbetween the child and child’s family, clinicians treating the child patient, and clinical researchers

that may want to continue to study the patient as he or she matures. This is especially important in

a condition such as early onset psychosis, which may include symptoms such as vulnerability to

distrust or even paranoia and subjective ways that children interpret what adults actually expect

of them (Conroy & Harcourt, 2009). In addition, greater understanding of the research and more

meaningful assent can contribute, as the child gets older, to the child feeling proud of having vol-

unteered to help medical research and other children. These feelings of pride and active agency

are predicted to be helpful for children suffering from a disorder that so markedly decreases their

ability to function.

This article proposes and outlines one such educative process to be used when assenting chil-dren with psychotic disorders, designed to promote increased comprehension of study purposes

and procedures. In addition, this article addresses the characteristics of psychotic disorders in

children and how specific symptoms related to the disorders may potentially impact full compre-

hension required for knowledgeable assent. Last, it aims to surmount the challenges presented

by the juxtaposition inherent in balancing participant protection with the need to investigate

particularly vulnerable populations such as children with active psychotic disorders.

YOUTH ASSENT: HISTORY AND CURRENT RESEARCHINTO IMPROVED PROCEDURES

For adults, the research consenting process is typically straightforward. Potential participants

are informed of the purposes, methods, procedures, and possible risks/benefits involved in the

research. They are also given time to think through the information and ask questions before

responding with their decisions regarding participation. Historically, this model has been applied

to children as well, with the addition of the primary step of seeking parental consent. However, as

children represent a vulnerable population by nature of their age, the assent process requires many

additional safeguards. In early discussions relating to children’s assent, commentators questioned

whether youth should participate at all in research due to the increased ethical and safety con-

siderations involved in their recruitment (The National Commission for the Protection of Human

Subjects of Biomedical and Behavioral Research, 1977). A number of investigative panels have

convened to address this issue. These reports include (a) the Subpart D of the Code of Federal

Regulations, which indicated that the combination of parental permission and child assent is the

most ethical way to involve children in research (Department of Health and Human Services,

2009); (b) the 1977 report of the National Commission for the Protection of Human Subjects of

Biomedical and Behavioral Research, Research Involving Children, which addressed the ethics

of youth involvement in research, as well as provided the recommendation that although parental

permission should be sought, ultimately the child’s choice should generally be respected; (c)

the Pediatric Research Initiative of the Children’s Health Act, which established that pediatric

research is a priority, in spite of the aforementioned ethical challenges involved (H.R. 4365–106th

Congress, 2000); and (d) a 2013 report by the Society for Research in Child Development Task

Force that addresses proposed changes (by the U.S. Department of Health and Human Services,2009) to federal regulations relevant to the conduct of research with children and youth (Fisher


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166 FROST ET AL.

et al., 2013). Based on these and related reports, the general consensus is that, although research

with children is essential to understanding medical and psychological issues that are youth spe-

cific, caution needs to be exercised to ensure that the process of including children in research isdone ethically.

In recent years, multiple investigations have continued to address the topic of child assent as an

ongoing issue of concern. Broadly, empirical studies demonstrate that children do have the capac-

ity to knowledgably assent. However, it appears as though developmental factors may also have an

influence on this process. Children younger than 9 years of age have shown decreased understand-

ing of study procedures when evaluated by investigators both before completing study tasks and

after (Ondrusek, Abramovitch, Pencharz, & Koren, 1998), and have additionally demonstrated

that voluntariness, the ability to participate freely in research without coercion, may be compro-

mised by the perception of adults as authority figures (Hurley & Underwood, 2002). As such,

these studies have recommended that investigators ensure that participants truly understand thatthey are allowed to withdraw without hurting the feelings of the investigators. Given the limita-

tions in comprehension that often occurs for those of younger ages, children with developmental

delays or cognitive processing problems resulting in issues of working memory and attention

would likely require even more attention to their assent. This particularly applies to children

with psychosis, because problems with cognitive processing is one feature characteristic of this

diagnostic category (Polanczyk et al., 2010; Ulloa et al., 2000; Vyas, Patel, & Puri, 2011).

ASSENTING CHILDREN WITH PSYCHOTIC DISORDERS:ADAPTING ADULT MODELS

Although research regarding the ability of children with psychosis to assent is limited, a number

of studies into this topic have focused on adults experiencing a psychotic disorder. Therefore,

if challenges inherent to child-specific assent are acknowledged and accounted for, an adapted

model to enhance assent by children with a psychotic disorder can be elaborated. To expand,

obtaining informed consent from adults with psychosis may be compromised by the (a) signif-

icant presence of specific psychotic symptoms (including thought disorder, hallucinations, and

delusions; Rutledge, Kennedy, O’Neill, & Kennedy, 2008); (b) comorbid cognitive processing

deficits, which may interfere with the ability to make a fully informed decision about participa-

tion in research (Koren et al., 2005); and (c) potential suggestibility that is comorbid with poor

cognitive capacity (Kaup, Dunn, Saks, Jeste, & Palmer, 2011). These problems also exist among

child and adolescent participants. In particular, even children without psychosis tend to accede

to the requests by adults perceived to be in positions of authority (Lambert & Glacken, 2011).

This acquiescence may result in children agreeing to participate without sufficient demonstration

of understanding the nature of the research process, or seemingly agreeing to participate despite

privately not actually wanting to do so. This latter concern will need to be accounted for in any

assent process for children with psychosis as part of a general assessment of decisional capacity.

To assess the decisional capacity of adult patients with psychosis, investigators have often

relied on the MacArthur Competence Assessment Tool—Clinical Research (MacCAT-CR), a

standardized, semistructured interview measure (Grisso, Appelbaum, & Hill-Fotouhi, 1997) that

addresses four important components of making an informed decision: understanding, appre-

ciation of the information, reasoning, and the ability to demonstrate awareness of a choice toparticipate (Moser et al., 2002). Although heavily used in research setting, investigators have


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found that use of the measure has its limitations. Researchers typically select the key compo-

nents of their studies and fit them to the MacCAT-CR standardized guide; however, studies have

reported that compared to healthy controls, participants with psychosis diagnoses may performslightly worse on the measure, although this performance is not immutable (Moser et al., 2002).

In particular, Kaup et al. (2011) reported that 83.3% of the adult patients with schizophrenia in

their study had made at least one error during the semistructured interview, with the most com-

mon one related to difficulty recalling aspects of the study information that had been disclosed to

them. However, when provided with additional time, multiple iterations of the information, and

opportunities to review the material, adult participants with psychosis were able to improve their

scores and reach a level of understanding that qualified them as capable of providing informed

consent (Carpenter et al., 2000; Kim et al., 2007) These findings suggest that with a repetitive

review process, which allows greater time for the processing of the information present about the

study during the consenting initiative, the effects of cognitive deficits may be minimized.While recognizing its limitations, the MacCAT-CR is also not age-normed for children.

Without the availability of the MacCAT-CR or similar tools, it may be much more difficult to

assess the capacity to assent for children with psychotic disorders. However, similar modifica-

tions in the procedures used to successfully complete the assessment instrument with psychotic

adults provide a useful model for addressing similar challenges that children and youth with

psychotic disorders present, and this framework can be utilized for a child-specific procedure.

As such, in adapting an assent process for use with children experiencing a psychotic dis-

order, investigators may need to rely on their own observations of multiple factors that should

be considered when assessing these children’s abilities to knowledgeably comprehend research.

For example, using only age or IQ as a defining cognitive factor for being able to competently

assent is not fully accurate, as clinical and cognitive factors are important to consider as well(Dorn, Susman, & Fletcher, 1995; Koren et al., 2005; Wolthers, 2006). To more accurately assess

the factors that might impact comprehension of a research project in which a child with a psy-

chotic disorder is being invited to participate, a brief review of the specific challenges involved in

childhood psychotic disorders and their associated symptoms is necessary.

SYMPTOMS OF CHILDHOOD PSYCHOSIS

Irrespective of specific diagnosis, children who are experiencing some form of psychosis often

exhibit similar symptoms to adults, albeit with varying severity and frequency. However, children

with disorders with psychotic features typically follow a more severe trajectory than do adult-

onset cases (Gogtay, Vyas, Testa, Wood, & Pantelis, 2011; Vyas et al., 2011).

Positive Symptoms

Positive symptoms of psychosis include hallucinations, delusions, paranoia, and grandiosity.

Auditory hallucinations are the most commonly reported positive symptom, with approximately

80% of children with psychotic-like symptoms self-reporting these hallucinatory experiences

(Polanczyk et al., 2010; Ulloa et al., 2000; Vyas et al., 2011). Delusions are the second most

commonly reported symptom, although the subtypes of paranoia and grandiosity are less com-

monly documented (Ulloa et al., 2000). A number of studies have determined that adults with


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168 FROST ET AL.

positive symptoms of psychosis are able to knowledgeably consent to research (Kaup et al.,

2011; Misra et al., 2008; Moye et al., 2007; Rutledge et al., 2008). Because these symptoms

also similarly present in children, positive symptoms may not necessarily represent a major bar-rier to knowledgeable assent but likely require formal evaluation to determine their intensity and

pervasiveness, with consideration of whether they might compromise the assenting process or

to what extent it is clinically appropriate to try to recruit these children into the study at that

time. Providers are often the source of referrals for children with psychotic disorders to research

studies, and thus these considerations can begin with a clinical evaluation to inform investigators

about a child’s capacity for participation.

Negative Symptoms

Negative symptoms of psychosis in children include flattened affect, avolition, social anhedo-nia, and alogia (Lyne et al., 2012). These symptoms often manifest in children as having more

behavioral problems and higher rates of social isolation by the age of 5 than their typically devel-

oping peers (Polanczyk et al., 2010). Other symptoms of childhood psychotic disorders include

premorbid developmental impairments in motor, language, and social development (Vyas et al.,

2011). In general, childhood-onset cases tend to result in more severe social impairment relative

to adult-onset cases, which might possibly be explained by the disorder’s disruption to a criti-

cal social developmental period in childhood and adolescence (Vyas et al., 2011). The Clinical

Antipsychotic Trials of Intervention Effectiveness Schizophrenia trial with adult patients found

that negative symptoms, and not positive symptoms, were associated with the ability to under-

stand consent information (Stroup et al., 2005). Although this association was weak (r = −.14,

p < .0001), the observed severity of negative symptoms in child and adolescent psychotic disor-

ders might reasonably be considered in the determination regarding the ability of children with

being able to provide informed assent (Stroup et al., 2005).

Cognitive Deficits

In contrast to finding a small effect of negative symptoms on the ability to consent, the Clinical

Antipsychotic Trials of Intervention Effectiveness trial found that cognitive abilities were strongly

and significantly predictive of an individual’s ability to understand the information presented

to him or her in the consent process, which the investigators determined stemmed from work-

ing memory deficits. Working memory is critical to understanding and processing information

and is implicated in the cognitive deficits seen in schizophrenia. Problems with working mem-

ory might result in a participant’s misunderstanding of the meaning of his or her role in the

research (Stroup et al., 2005). Therefore, impairment in cognitive functioning is an important

variable to consider when attempting evaluation of competence to assent in children with psy-

chotic disorders. Of note, previous research in adults with schizophrenia spectrum disorders

indicated that cognitive impairments are related to and can adversely affect decisional capacity

during the informed consent process (Carpenter et al., 2000; Palmer & Jeste, 2006). Children

with psychotic disorders present similar neurocognitive profiles to adults with schizophrenia

spectrum disorders (Rhinewine et al., 2005). Research suggests that children with psychotic

symptoms present with generalized, rather than specific, neurocognitive impairment in memory,


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attention, and learning (McClellan, Prezbindowski, Breiger, & McCurry, 2004; Rhinewine et al.,

2005). In addition, childhood psychotic disorders are associated with significantly lower IQs

(approximately 10–20 points) when compared to their typically developing peers (Fagerlund,Pagsberg, & Hemmingsen, 2006). These cognitive impairments do not appear to differ signifi-

cantly among types of childhood psychotic disorders (e.g., childhood onset schizophrenia, early

onset schizophrenia, Psychotic Disorder–Not Otherwise Specified, and pediatric bipolar disor-

der cases; Kumra et al., 2000; McClellan et al., 2004; Nieto & Castellanos, 2011), suggesting

that neurocognitive deficits may be more generalized to psychotic disorders rather than a specific

diagnosis.

Given these complexities, it is critical that children experiencing psychotic symptoms receive

comprehensive and appropriate treatment throughout the course of their participation in any

research project. Investigators should be cautious when considering withdrawal of treatments,

particularly psychopharmacological interventions, with these children. For example, Polizos,Engelhardt, Hoffman, and Waizer (1973) reported on the negative clinical effects of withdrawing

medication from children diagnosed with schizophrenia, resulting in “neurological withdrawal

emergent symptoms” and clinical relapse among a majority of the participants. Careful collab-

oration between the research and clinical treatment teams for the children is essential to their

well-being and capacity to participate in a study.

OFFSETTING SYMPTOMS IN THE ASSENTING PROCESS

A study by Carpenter and colleagues (2000) found that engaging individuals with schizophre-

nia in an educative process that involved (a) chunking the consent into smaller components andpresenting the information in individual steps, (b) asking study-process questions, and (c) having

participants reiterate the procedures served to alleviate some deficits in decisional capacity that

were initially present. The results of the aforementioned study (Carpenter et al., 2000) suggest

that an educative process can minimize the effects of cognitive impairments and, as such, help

adults with schizophrenia to demonstrate sufficient capacity to consent to participate in research.

However, it is important that participants be monitored throughout the study to ensure that they

demonstrate continued understanding and consent to their involvement in the study until its com-

pletion. For example, Lambert and Glacken (2011) have undertaken this periodic reassessment of

verbal consent with success. For example, a child’s “well-being” can be monitored for any signs

of seeming confusion about or growing inattentiveness to the assenting process and/or the tasks

that are presented as part of the study and any behaviors that are signs of distress. Investigators

have also indicated that comprehension can change over the course of participation in a research

project, especially for longitudinal studies (Stroup et al., 2011), or those that involve multiple

study visits. Although some research shows that capacity to consent and study understanding

may remain steady over time, predictors of decline in consenting abilities (e.g., poor cognitive

performance, worsening positive or negative symptoms) and other significant clinical or environ-

mental changes suggest the need to revisit use of earlier procedures for securing consent or assent

to reaffirm their willingness to participate (Morris & Heinssen, 2014). Thus, repetition and con-

tinued checks on assent by children with a psychotic disorder may also be necessary throughout

the duration of the study, to ensure not only continued understanding but continued voluntarism

as well, with explicit emphasis on the choice for a child to discontinue participation if she or heso chooses.


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170 FROST ET AL.

We therefore propose that a series of steps may serve to remedy these difficulties when

attempting to request assent to participate in a research project from children with psychosis.

First, following the Carpenter et al. (2000) study, the investigator might assess comprehensionby engaging in an active question session with the children about the research protocol that has

been previously described, the tasks and activities that a participant would have to undertake, and

the potential risks and/or benefits of the study. This exercise may permit investigators to more

clearly assess the assent capacity of a child with a psychotic disorder through explicit and imme-

diate feedback about a potential participant’s comprehension of the study. Of note, studies have

shown that such questioning is beneficial to increase understanding of the research study among

unaffected youth older than 8 years old (Hurley & Underwood, 2002). Second, because it may

not always be possible to question the participants orally, a written quiz may potentially serve as

an alternative strategy to take the place of this question and answer session. Although there might

still need to be a discussion of any incorrect answers, this strategy may allow for more targetedquestioning regarding potential misunderstandings or discrepancies. For very young participants,

reliance on written materials may not represent the best option given their developmental limita-

tions, and investigators may consider the analogous use of a pictorial explanation and evaluation

to assess understanding instead.

INCREASING THE CAPACITY TO ASSENT: A PROPOSED PROCESS

Collectively taken, this literature suggests that an expansive, educational, and multimodal assent

process, adapted for age and reading level, may benefit children with psychotic symptoms as they

consider participation in a research study. Such an assenting process may be undertaken accordingto the following steps, among which include many of the components already mentioned herein.

First, as previously mentioned, parental or guardian consent should be obtained before seeking

the assent of the child. This process poses its own ethical considerations of which investigators

should be cognizant, as several factors may serve to influence parents’ ability to provide consent

and their reasons for doing so. For example, given that family history of psychosis is a known

risk factor for the development of psychosis, it’s possible that parents may exhibit their own

neurocognitive impairments and thus cannot provide fully informed consent on behalf of their

child (Cassetta & Goghari, 2015). In addition, the influence of external factors such as monetary

incentives, elements of the parent–child relationship, and/or previous involvement with research

should be considered (for further review, see Masty & Fisher, 2008).

Then, before proceeding with presentation of any detailed study descriptions, investigators

should assess the emotional well-being of the children with particular attention to the presence

of any active distress that may cause interference with or disruption of the assent process or

participation. The purpose behind assessment of emotional well-being of the child is to ensure

that she or he maintains a reasonable level of true comfort with participation, thereby gauging

the child’s ability to tolerate the assent process and subsequent study procedures before they

are undertaken. After presenting the participant with the study material that is adjusted for age

level, the researcher could engage in a question-and-answer session about the research as one

way to assess a participant’s understanding of study procedures. Constructing assent documents

at a basic reading/comprehension level has been shown to be helpful in helping children to more

fully understand the goals/procedures and tasks required of a study, and ultimately can lead


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to their more fully informed assent to participate in research (O’Lonergan & Forster-Harwood,

2011; Tait, Voepel-Lewis, & Malviya, 2007; Wolthers, 2006). Given relevant age differences in

cognitive capacity (see IOM, 2004, p. 180, Table 5.1), investigators may again consider the useof nonwritten assent materials such as pictograms or storybooks for preschool and school-age

participants. For example, it may be helpful for younger children to see pictures of what will

actually occur during study procedures while the investigator explains it, such as a picture of a

child with an electroencephalogram cap on if an electroencephalogram is part of the protocol.

To supplement, investigators could physically show children the equipment they might be using,

if possible and appropriate, or demonstrate how a certain procedure might go, such as in the use

of a mock MRI scanner. Together, these steps constitute the first part of the proposed process.

Second, to further increase and evaluate comprehension for child participants with psychotic

disorders, the investigator could then invite the child to complete a brief review questionnaire

about the purpose of the study, its procedures, benefits, and anticipated impact on the child’slife. This questionnaire could be completed by the child after initial presentation of the assent

paperwork and corresponding verbal explanation. If necessary, researchers could subsequently

discuss any inaccurate responses with the participant to clarify and/or improve their understand-

ing. This review might also serve to reinforce and reiterate study details, especially if combined

with shorter assent forms that can be more easily understood (Jefford et al., 2011).This back-and-

forth verbal interaction may further encourage children to ask questions and provide feedback to

investigators about their feelings regarding the study .

Third, the proposed process suggests that investigators closely monitor the child’s well-being

throughout study procedures. This includes looking for any signs of possible distress during the

study that may indicate the child is no longer willing or able to continue participating, as chil-

dren may feel that they are required to continue study protocols even if they no longer want toparticipate (Ondrusek et al., 1998). This may also include a review of any worsening of present-

ing symptoms and/or decline in overall functioning during the course of study participation. For

example, one monitoring strategy that investigators could utilize would be frequently checking in

with the participant to determine whether a break is needed and paying attention to nonverbal cues

indicating fatigue or wandering attention, which may indicate a lack of comprehension. Another

strategy to emphasize continual voluntarism is to offer the child an additional method for possible

discontinuation or to decline participation (e.g., picture of a stop sign, or the letter “X”) that she

or he may put forward at any point, both during the assent process and throughout participation.

In so doing, the child has an additional means of objecting to participation, should the child want

to object or stop for any reason. Thus, this multimodal process might be easily conceptualized

as a checks-and-balances system, relying on the responsibility of the investigator to monitor and

continually assess the participant’s mental status. In this way, the investigator remains aware of

the participant’s apparent comprehension over the course of his or her participation.

A thorough and interactive (i.e., featuring questions and answers) debriefing meeting after

completion of the study may also be helpful, as previous studies have indicated that at debrief,

children still do not always comprehend study procedures (Hurley & Underwood, 2002),

hence the reliability of their responses during the project may need to be carefully reviewed.

A schematic outline of these multimodal, educational steps is presented in Figure 1. Taking into

consideration the information just discussed, it is suggested that these steps be considered for

inclusion in all research studies that involve children experiencing a psychotic disorder.


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172 FROST ET AL.

Post study assessment and debrief- screen participant for appropriate response and any signs of distress

Intra-protocol comprehension maintenance

Periodically assess participant symptoms and level of stress Re-confirm participant assent during participation

Proceed with sudy as appropriate depending on participant comprehension and assent/consent

Review of research comprehension

Protocol comprehension assessment

Provide assent quiz Encourage participant to ask questions

Orally present content of study-include an optimal review of an entire diagram of the sequence of study components

Provide written description of study at an appropriate level of readability or use of other developmentallyappropriate materials (e.g., pictures, cartoons, video presentation)

Evaluate overall functiong and child's well-being that might interfere with processing of study information

Assess for hallucinations/delusionsAssess for baseline cognitive language

comprehensionAssess for negative symptom severity

Obtain parental or guardian consent

FIGURE 1 Flowchart of proposed educative, multimodal assent process

for youth with psychotic disorders.

SUMMARY

The affirmation of thorough understanding and voluntarism of a study for all child participants is

essential to an informed assent process in order to truly respect the rights and safety of research

participants. Due to their age and various cognitive limitations, it is necessary to adjust the assent


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process for children, especially those at risk for and those experiencing psychotic disorders.

The process proposed in this article provides one way to more sensitively assent child partici-

pants while actively promoting understanding and continued comprehension and willingness toparticipate.

As studies continue to seek empirical evidence and deeper knowledge regarding the etiology

and treatment of psychiatric conditions like psychosis, several important ethical questions and

concerns related to research assent and participation require further consideration. For exam-

ple, under what circumstances might it be appropriate to require treatment withdrawal and/or

medication-free intervals for participation in a given study? As psychosis and psychosis risk

research expand internationally, how can investigators adapt assent procedures to address rele-

vant cultural differences? Throughout future investigations, care must be taken to address these

concerns, and thereby balance the benefits of research with the health and safety of those

participating.

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Frost Et Al 2016 the Ethical Inclusion of Children With Psychotic Disorders in Research Recommendations for an Educative Multimodal Assent Process