Interventions for Children & Adolescents with Diabetes

Margaret Grey, DrPH, RN, FAAN

Dean & Annie Goodrich Professor

Yale School of Nursing

Objectives

• Review the development of

cognitive-behavioral interventions

for youth with diabetes

• Describe a program of research on

such interventions in type 1 diabetes

Type I Diabetes• Alterations in metabolism

– Carbohydrates– Fats– Proteins

• Complications– Microvascular– Macrovascular– Neurological

• Quality of Life

Epidemiology• Most common metabolic disease in

childhood

• 176,000 American youth

• 1 in 400-600 children

• 18 new cases per 100,000 annually

• Peak age - male: 12-14 years female: 10-12 years

www.diabetes.org, 2007

Age-Specific Incidence Rates

0

5

10

15

20

25

30

35

0 2 4 6 8 10 12 14 16 18

Age in years

100,000Rate

Treatment

• Insulin to achieve near-normal blood glucose levels

• Diet sufficient for growth• Monitoring of blood sugars• Regular physical activity• Glycosylated hemoglobin levels quarterly

to assess overall control• Maintain psychological well-being• Prevention of complications

Diabetes Control & Complications Trial

• Improved control associated with 50-75% reduction in complications

• HbA1c linearly associated with complications

• No adverse effects on:– Cognitive function– Quality of life– Psychological symptoms

DCCT Research Group. (1993). New England Journal of Medicine

RECOMMENDATION

“Most teenagers with IDDM should be treated with

intensive therapy since their long-term outcome should be

measurably improved.”

DCCT Research Group. (1994). Journal of Pediatrics

Educational Interventions

• Cornerstone of treatment• Necessary for self-management• Multiple approaches

– Individual– Structured self-management training– Technology

• Mixed results but limited effects beyond knowledge

Family Interventions

• Target family and child with diabetes• Newer approaches

– Satin, multi-family approach– Wysocki, behavioral family systems

therapy– Anderson, parent-child conflict

• Outcomes include individual functioning

Intervention to Maintain Parent-Adolescent Teamwork

• Pilot Project– Powered for conflict, not for HbA1c

• N=85, age 10-15 years• Intervention

– Office-based– Focus on importance of parent-teen

responsibility sharing– Ways to avoid conflict

Anderson, et al. (1999). Diabetes Care, 22, 713-721.

Teamwork Intervention

• N=105, age 8-17 years

• Teamwork intervention vs. standard care– Importance of parent-child

responsibility sharing– Ways to avoid conflict– Office-based

Laffel, et al. (2003). Journal of Pediatrics

Cognitive-Behavioral Interventions

• Growing awareness of the negative impact of diabetes on psychosocial functioning

• Need for more than educational approaches to improve outcomes

Cognitive-Behavioral Interventions

• Stress management & relaxation

• Social support groups & camps

• Coping skills training

Social Support

• Few studies

• Goal to enhance the environment• Peer group intervention (Anderson, et al,

1989)

– Clinic-based, prevent adolescent decline

– Improvement in multiple areas, including HbA1c

Stress Management & Relaxation

• Stress worsens metabolic control• 12 session program (Mendez & Belendez,

1997)– Improved knowledge, adherence, stress

• Camp-based stress management program (Smith, et al., 1991)

– Intent to use more problem-focused coping– Fewer diabetes-related stressors

Coping Skills Training

Preliminary Work

• Avoidance coping associated with poorer outcomes

• Depression common in diabetes

• Difficult to engage teens in intensive regimens

• Difficulties in management may be associated with social situations

Coping Skills Training

• Increase sense of mastery and competence by retraining non-constructive coping styles and forming more positive patterns of social behavior.– Focus on common social issues in

diabetes management– Role play, art, discussion

Coping Skills

• Social problem solving

• Communication skills training

– Social skills training, assertiveness

• Cognitive behavior modification

• Conflict resolution

Social Problem-Solving

• Designed to help youth look at ways of handling peer pressure and raises awareness of possible consequences of their decisions– Focus is on process of problem-solving,

not necessarily the content– Steps: Identify the problem, set goals,

develop alternative solutions, examine consequences, choose solution, & evaluate the outcome

Social Skills Training

• Allows youth to work with peers and adults in a manner leading to positive results for all

• Enhances self-confidence, peer acceptance, and adjustment

• Provide concrete instructions on handling certain situations, role play appropriate model behavior, practicing in group and in life

Assertiveness Training

• Express themselves in direct, honest, and appropriate ways

• Observation of others and to reflect on their own behavior and its effect on others

• Role-play helpful in teaching this skill

Cognitive Behavior Modification

• Help youth recognize their own thoughts and feelings

• Helps to recognize sources of stress and decrease negative responses to stress

• May help to identify thoughts that are not based in fact

Conflict Resolution

• Conflict may be positive or negative, constant in youth’s lives

• Skills to resolve conflicts in a win-win manner

• Focus on reworking situations, with the hope of finding a solution with better outcomes than the usual

CST Protocol

• Teens - 5 weekly sessions

– Use scenarios of common social issues

in diabetes management to begin

discussion

• Children & Parents – 6 sessions

Study 1

• To determine if coping skills training in conjunction with intensive diabetes management vs. intensive management with education enhances:– Metabolic control (serial HbA1c)– Psychosocial well-being (depression, self-

efficacy, quality of life)– Rate of adverse events (severe hypoglycemia,

weight gain)

Subjects

• Type I diabetes• Desire to improve metabolic control• Age: 12.5-20 years at entry• No other chronic illness• HbA1c in last year > 7.2 & < 14 %• No severe hypoglycemia in last 6 mos.• Appropriate grade for age

Baseline Data• Physiological data

– Height, weight– Tanner stage– HbA1c

• Psychosocial data• Intensification of therapy (MDI, pump)

– Intensive Education

Follow-up• Telephone follow-up

– Daily– Weekly

• Visits to outpatient CCRC– Diabetes management– HbA1c– Education

• Initial study follow-up x 1 year• Followed for up to 5 years

Baseline Comparison (N=77)

Experimental Group

(N=41)

Age = 14.1 + 1.8 years

38 White

1 African American

2 Hispanic

21 females, 20 males

HbA1c = 9.1 + 1.5%

Control Group

(N=34)

Age = 14.6 + 2.2 years

31 White

1 African American

2 Hispanic

22 females, 12 males

HbA1c =9.2 + 1.4%

Metabolic Control Over 12 Months(CST vs. Routine, N=72)

6

7

8

9

10

0 6 12

Hb

A1c

% CST

RC

MonthsF (groupxtime) = 5.3, df=2, p<.01

Diabetes Treatment by Group (N=77)

• MDI vs. CSII, p=.4– MDI=> 3 injections– CSII=pump

• Total Daily Dose:– 1.3+0.4 vs. 1.3+0.7

Units/Kg 0

5

10

15

20

25

30

N

I P

RC

CST

All comparisons, p>.05

Adverse Events by Group

0

5

10

15

20

25

30

Severe DKA Wt Gain

N

Cnt-M CST-M Cnt-F CST-F

* difference CST vs. control, p<.02

*

*

Quality of Life: Impact (N=77)

4042444648505254565860

Baseline 6 Months 12 Months

CST

Control

F(group x time)=5.4, df=2, p=.005; F(time)=12.5, df=2, p<.001

Diabetes Self-Efficacy(N=77)

80

90

100

110

Baseline 6 Months 12 Months

CST

Control

F(groupxtime)=5.4, df=2, p=.005; F(time)=14.1, df=2, p=.001

Impact of CST

• Improved metabolic control• Better self-efficacy• Less negative impact of diabetes on

quality of life• Fewer worries about diabetes• In females, fewer severe

hypoglycemic events and less weight gain

Building Evidence-From Efficacy to Effectiveness

• CST for pre-adolescents and their parents

• CST as an addition to nutrition and exercise for young adolescents at high risk for type 2 diabetes

• Moving to dissemination

CST for School-Aged Children and A Parent

• Can we improve the transition to

adolescence with CST?

– Children age 8-12 years and a parent

– RCT

– Child and parent outcomes

Parents and Children Together

Metabolic Control (N=41)

6.5

7

7.5

8

8.5

9

9.5

Baseline 3 Months 6 Months 12 Months

Control

CST

HbA1c

%

F=2.3, p=.1

Family Adaptability (N=41)

40

44

48

52

56

60

Baseline 3 Months 6 Months

CSTControl

F=5.33, df=2, p=.007

Parent’s Depressive Symptoms (N=41)

6

8

10

12

14

16

18

Baseline 3 Months 6 Months

CST

Control

F=3.91, df=2, p=.02

Diabetes-Related Conflict

10

15

20

25

30

35

Baseline 3 Months 6 Months

CSTControl

F =3.13, df=2,

p=.04

Next Steps:Moving to Dissemination

Problems with Previous Studies

• 50-60% enrollment of eligible subjects

• Conducted in a single tertiary medical center

• Less than 15% minority youth

• Small group format limited clinical applicability

Conceptual Framework

AgeGenderSESDevelopmental statusType 1 diabetes

Depressive Sx

StressCopingSelf-efficacySocial competenceFamily support

Family Adaptation Conflict resolution

Individual Adaptation Metabolic control Quality of life

Pre-existing Characteristics Individual Responses & Context Level of Adaptation

CST

Web Design

• Team approach– CST trainers, Research team, Web

development staff

• Initial focus group– Youth and parents– Likes and dislikes in web sites

• Web sites developed – CST & Education– Interactive with CST staff

Think Aloud Usage

• 3 adolescents

• 2 prototype sessions

• What they were thinking as they went through

• What they didn’t like

• Anything else that came to mind

Think Aloud Results

• “This is really cool. I love the characters. I want to name them. I like that you can see the (insulin) pumps”. “I can definitely relate (to the characters).” “I really like the graphic novels.”

• “The body questions really make me aware of how much my body is affected by stress.” “Great stress relieving examples – I would try them all.”

• Suggestions for improvement– Clarify directions– More about stressors– Provide better alternatives for some of the character

dialogue.

https://transact.med.yale.edu/teencope/Login.asp

Pilot/Feasibility Study

• 12 subjects assigned randomly by computer– 58% Female, 14.4 +.9 yrs.

• All data collection online

• Usage Patterns

• Preliminary outcomes to 3 months to date

Usage Patterns

• Excellent participation• Decreased slightly over time• 120 logins over 6 weeks of active intervention• TEENCOPE 2x as many logins as Education• High CDI (> 12) at baseline logged into the

website with the greatest frequency• TEENCOPE program engaged adolescents to a

greater extent and may be particularly appealing to adolescents with high levels of depressive symptoms.

Self-Efficacy

0

10

20

30

40

50

60

0 6 12

CST

Education

P=.12

Quality of Life

68

70

72

74

76

78

80

82

84

0 6 12

CST

Education

P=.02

Proposed Study

• Enhance TEENCOPE with animation• Online data collection• Multi-site clinical trial

– Yale (mostly White)– CHOP (Black and Hispanic)– Arizona (Hispanic and White)

• 12 month follow-up• Mediators & Moderators

What we know…

• Incorporate behavioral approaches into standard diabetes care for youth with & at risk for diabetes

• CST is a useful adjunct to usual clinical care

• Goals of treatment involve not only enhancing metabolic outcomes but functional and quality of life

Acknowledgements

• Great research teams

• Funding– 1 & 2 R01NR04009– 1R21DK59248– 1R01NR008244

Thank You