1. Transitioning to Adolescence with Type 1 Diabetes: Evidence-based Interventions to Optimize Health and Psychosocial Outcomes Barbara J. Anderson, Ph.D. Professor of Pediatrics Baylor College of Medicine Houston, TX

2. Overview of Presentation 1. Clinical context of type 1 diabetes (T1DM) management in 21 st century. 2. Normal development from school –aged through early adolescence: Lessons from research on youth with T1DM during this transition to adolescence. 3. Review my clinical research with transitioning teens and their parents—at Joslin Clinic and at Baylor/TCH

3. I. Clinical context of type 1 diabetes (T1DM) management in 21 st century.

4. I. Advances in the management of type 1 diabetes in 21 st century New types of insulin (basal, rapid acting) New types of insulin (basal, rapid acting) Very portable Blood Glucose (BG) monitors Very portable Blood Glucose (BG) monitors Yet, adherence is a problem! Continuous BG monitors Continuous BG monitors Advances in insulin delivery systems (pumps) Advances in insulin delivery systems (pumps) No ‘closed loop’ system yet

5. Landmark Studies Impact the Care of Youth with T1DM Data from DCCT demonstrate that BG levels kept as close to normal as possible reduce the risk of microvascular complications of T1DM (NEJM, l993). Data from DCCT demonstrate that BG levels kept as close to normal as possible reduce the risk of microvascular complications of T1DM (NEJM, l993). Data from EDIC demonstrate that a period of optimal glycemic control early in the course of diabetes, has a ‘protective’ effect against later macrovascular complications of T1DM (NEJM, 2005). Data from EDIC demonstrate that a period of optimal glycemic control early in the course of diabetes, has a ‘protective’ effect against later macrovascular complications of T1DM (NEJM, 2005).

6. Landmark Studies Impact the Care of Youth with T1DM Intensive management, aimed at physiologic insulin replacement with multiple daily injections or insulin pump therapy, has become the “standard of care” for youth with T1DM, per Guidelines of ADA & ISPAD. Intensive management, aimed at physiologic insulin replacement with multiple daily injections or insulin pump therapy, has become the “standard of care” for youth with T1DM, per Guidelines of ADA & ISPAD.

7. The “Paradox of Progress” Facing 21 st Century Families Living with DM Innovations in insulin delivery, insulin types, and BG monitoring technologies make intensive management, near-normal BG control, & reduced risk of long-term complications of T1DM a reality. Innovations in insulin delivery, insulin types, and BG monitoring technologies make intensive management, near-normal BG control, & reduced risk of long-term complications of T1DM a reality. Practical, financial, cognitive, & emotional burdens of diabetes management are increasing for children and parents and for pediatric diabetes teams. Practical, financial, cognitive, & emotional burdens of diabetes management are increasing for children and parents and for pediatric diabetes teams.

8. The “Paradox of Progress” Facing 21 st Century DM Teams Increased technology for DM mgt. requires increased education of pt./family, with increasing workload on multidisciplinary diabetes teams, in era of health care cost containment. Increased technology for DM mgt. requires increased education of pt./family, with increasing workload on multidisciplinary diabetes teams, in era of health care cost containment.

9. The “Paradox of Progress” Facing 21 st Century DM Teams Barriers to optimal glycemic control for families include time demands of DM management, balancing with quality of life, “diabetes burn-out” in adolescents, and family conflict (Anderson et al, 2002). Barriers to optimal glycemic control for families include time demands of DM management, balancing with quality of life, “diabetes burn-out” in adolescents, and family conflict (Anderson et al, 2002). Need for low-cost, effective interventions to support intensive management in pediatric diabetes. Need for low-cost, effective interventions to support intensive management in pediatric diabetes.

10. II. Normal development from school –aged through early adolescence: Lessons from research on youth with T1DM during this transition to adolescence. II. Normal development from school –aged through early adolescence: Lessons from research on youth with T1DM during this transition to adolescence.

11. II. Normal Developmental Tasks of School Age youth (6-10 yr.) and parents Explosion of skills (cognitive, athletic, artistic, physical) Explosion of skills (cognitive, athletic, artistic, physical) Importance of dyadic friendship and team play Importance of dyadic friendship and team play Foundations of self-esteem Foundations of self-esteem Child must participate with peers Child must participate with peers Parent must balance child’s expanding world with setting reasonable limits; foster autonomy while maintaining involvement in child’s world. Parent must balance child’s expanding world with setting reasonable limits; foster autonomy while maintaining involvement in child’s world.

13. Lessons from research on T1DM in School-Aged Youth 1) Since 1990, research consistently documents that parent & child working together to manage diabetes predicts better adherence & improved glycemic control. Brought about a clinical “paradigm shift ” The “Old Message” (pre-1990): “The child with diabetes must be independent in disease management.” The “New Message” (post-l990): “The child with diabetes must work interdependently with parents, and this teamwork must change with development.”

14. Normal Developmental Tasks of Young Transitioning Teens (11-13 yr.) and parents Pubertal changes impact self-image. Pubertal changes impact self-image. Peers increase in value (vulnerable). Peers increase in value (vulnerable). Privacy is important. Privacy is important. Power shifts in P-C relationship increase family conflict. Power shifts in P-C relationship increase family conflict. Parent learns to acknowledge this is a period of insecurity and intensity, to negotiate, to have consistent expectations, to set limits, to maintain involvement & support. Parent learns to acknowledge this is a period of insecurity and intensity, to negotiate, to have consistent expectations, to set limits, to maintain involvement & support.

16. Lessons from research of T1DM in Young Transitioning Teens-1 Over the transition to adolescence, data from Wysocki( ISPAD, 2005) show an increase in child’s responsibility for DM tasks; in DM conflict with parent; with simultaneous deterioration in adherence and glycemic control. Over the transition to adolescence, data from Wysocki( ISPAD, 2005) show an increase in child’s responsibility for DM tasks; in DM conflict with parent; with simultaneous deterioration in adherence and glycemic control.

17. Child Responsibility by Age Group (Wysocki, 2005)

18. Diabetes Conflict by Age Group (Wysocki, 2005)

19. Adherence by Age Group (Wysocki, 2005) Adherence by Age Group (Wysocki, 2005)

20. HbA 1C by Age Group (Wysocki, 2005)

21. DCCT – Adult & Adolescent Cohorts Adults Adolescents DCCT: N Engl J Med. 1993 J Peds, 1994

22. DCCT: Adolescents Vs Adults significantly higher A1c’s: significantly higher A1c’s: Intensive-8.1 vs 7.1%, Conventional-9.8 vs 9.0% Intensive-8.1 vs 7.1%, Conventional-9.8 vs 9.0% significantly more severe hypoglycemia: significantly more severe hypoglycemia: intensive- 86 vs 57/100-pt-yrs conventional-28 vs 17/100-pt-yrs had significantly more DKA than adults: had significantly more DKA than adults: Intensive-2.8 vs 1.8/100-pt-yrs Conventional-4.7 vs 1.3/100-pt-yrs

23. Lessons from research on T1DM in Young Transitioning Teens-2 Research consistently documents that parent-involvement in, and low p-c conflict around, DM tasks is related to improved adherence and glycemic control in young teens with T1DM. (Anderson et al, 2002, 2007; Cameron et al, 2005; Gray et al,2000; Laffel et al, 2003)

25. From late school-age to early adolescence (10 – 14 years) Increasing: P-C DM Conflict  P-C DM Conflict Child Sole Responsibility  Child Sole Responsibility HbAlc  HbAlc Decreasing: Decreasing: Parent Involvement  Parent Involvement Adherence  Adherence

26. Lessons from research of T1DM in Young Transitioning Teens-3 Prospective, longitudinal studies report that early in the course of diabetes, patterns (i.e. ‘tracking’) are established in a) child’s adherence behaviors b) family support/involvement & family conflict behaviors c) metabolic control (A1c) (Grey et al, 1999; Hauser et al, 1990; Kovacs et al, 1996)

27. Implications for improving adolescent health outcomes 1. Intervene during the transition to adolescence. 2. Intervene early in the course of diabetes with “potentially modifiable” family factors (e.g., parent/child DM teamwork & parent/child DM conflict) that promote adherence and optimal glycemic control. 3. With limited health care resources to implement intensive therapy,  need for cost – effective interventions which are translatable across pediatric practices

28. Research Initiatives to Optimize Adherence and Glycemic Control 4 pediatric randomized-controlled trials reviewed in a meta-Analysis by Winkley et al, ( BMJ, 2006): 4 pediatric randomized-controlled trials reviewed in a meta-Analysis by Winkley et al, ( BMJ, 2006): Coping Skills Training (Gray) Coping Skills Training (Gray) Behavioral Family Systems Therapy (Wysocki) Multisystemic Therapy (Ellis) Multisystemic Therapy (Ellis) Teamwork Intervention (Anderson) Teamwork Intervention (Anderson) Concluded: Pediatric interventions had “moderate” effect on glycemic control, while adult interventions had “no” effect. Concluded: Pediatric interventions had “moderate” effect on glycemic control, while adult interventions had “no” effect.

29. Research Initiatives to Optimize Adherence and Glycemic Control Coping Skills Training: small group sessions led by trained therapist Coping Skills Training: small group sessions led by trained therapist Behavioral Family Systems Therapy: multiple family sessions led by trained therapist Behavioral Family Systems Therapy: multiple family sessions led by trained therapist Multisystemic Therapy: delivered in home by trained therapist Multisystemic Therapy: delivered in home by trained therapist Teamwork Intervention: integrated into regular clinic visits delivered by research assistant Teamwork Intervention: integrated into regular clinic visits delivered by research assistant

30. III. Review my clinical research with transitioning teens and their parents—at Joslin Clinic and at Baylor/TCH III. Review my clinical research with transitioning teens and their parents—at Joslin Clinic and at Baylor/TCH

31. III. Research Question In youth recently diagnosed with Type 1 DM (< 5 years), will a brief, family-focused intervention as part of routine ambulatory care over a 2-year period prevent the expected  in adherence,  in metabolic control, and  in parent involvement without  family conflict over DM management?

32. Inclusion/Exclusion Criteria 10-15 years 10-15 years Duration of diabetes > 6 mos., 6 mos., <5 yrs. No serious medical/psychiatric co- morbidities No serious medical/psychiatric co- morbidities Lived with family in home Lived with family in home No plans to re-locate to new area No plans to re-locate to new area Established Joslin patient, w/at least 2 visits in past year Established Joslin patient, w/at least 2 visits in past year

33. Treatment Groups GROUP #1: TEAMWORK INTERVENTION Involved parent and child for 20 min. with a curriculum interacting with an RA, integrated into a regular follow-up diabetes outpatient medical visit with a multidisciplinary team over 2 years GROUP #2: STANDARD CARE Patients had routine follow-up diabetes outpatient medical visit with a multidisciplinary team over 2 years. Family receives the curriculum in book form at the end of 2-year period.

34. Randomized TW SC Baseline Evaluation Session 1 T1DM and your Family BGM and A1c Blame and Shame Session 4 Teamwork Meal planning Burnout Inter- dependence Session 8 Review Year 1 Evaluation Year 2 Evaluation Research Design

35. Session #3 Talking about blood sugars Avoiding blame and shame Session #8 REVIEW Session #1 Diabetes and the Family Challenges of diabetes Session #2 Tools for Diabetes care Blood sugar monitoring A1c Session #4 Sharing the burden Identifying blood sugar patterns Session #5 Flexibility in meal planning Carbohydrate counting Session #6 Preventing burn-out Achieving flexibility Session #7 Miscarried helping Interdependence Reducing conflict Map of the Family Project

36. Intervention Curriculum a)Preventing “Diabetes burnout” and “Miscarried helping” b) Improving Family communication about DM c)Reducing and preventing conflict d)Fostering realistic expectations/avoiding perfectionism e)Building Parent-Child DM teamwork

37. Family Communication and Conflict  How you think about DM... - “What does a blood sugar of 400 mean for my child?” - “Why is his/her DM getting worse?”  How you feel about DM … - “I’m scared when I see a blood sugar of 400. Why can’t s/he have stable blood glucose levels?”  How you talk about DM… - “That blood sugar is so bad! What did you eat?”

38.  Growth/Puberty  Stress  Illness  Dawn phenomenon  Too little insulin  Food  Unknown  Exercise  Stress  Illness  Insulin  Not Enough Food  Unknown Sample Session #3 Responding to Blood Sugars

39. Sample Session (cont.) That scares me! A high blood sugar like that could cause problems! Dad, my blood sugar is 385. Dad’s really mad at me! He’d be happier if my blood sugar were 120 or if I didn’t check at all! 385?! Why so high? What did you eat? 1) OCCASIONAL HIGH BLOOD SUGARS DON’T LEAD TO COMPLICATIONS. It is normal for growing children to have out-of-range blood sugars. An occasional blood sugar of 300 or even 400 or more will not cause complications. 2) THERE IS NO SUCH THING AS A “BAD” BLOOD SUGAR. Any result from blood sugar monitoring is good because it gives helpful and important information that lets you make the best choices in insulin, activity, and food.

40. Sample Session (cont.) Kids Don’t Want to Check & Find it Harder to Tell the Truth “High” or “Low” Blood Sugars Families feel frustrated & Discouraged Kids Feel Discouraged & Blamed Parents May Accuse & Criticize Families may worry about complications A Closer Look at the Vicious Cycle

41. Baseline Pt. Characteristics Teamwork (n=50) Standard Care (n=50) Age (yrs) 11.9 ± 2.4 12.2 ± 2.2 T1DM Duration (yrs) 2.7 ± 1.6 Gender (% male) 5452 BMI (kg/m²)* 19.8 ± 3.1 21.3 ± 3.7 Developmental Stage (%) Pre-pubertal (Tanner I) Pre-pubertal (Tanner I)3836 Pubertal (Tanner II-IV) Pubertal (Tanner II-IV)5048 Post-pubertal (Tanner V) Post-pubertal (Tanner V)1216 *BMI was significantly different between groups at baseline. The Teamwork group had significantly more single parent families at baseline. There was no significant difference in parental SES between groups at baseline.

42. Baseline Diabetes Characteristics *No significant difference between groups in BGM frequency at baseline. Teamwork (n=50) Standard Care (n=50) Insulin (U/kg/day) 0.9 ± 0.2 0.9 ± 0.3 Mode of Insulin Therapy (%) 2 inj/day 2 inj/day5254 3 inj/day 3 inj/day4042 4 inj/day 4 inj/day84 Pump Pump00 BGM* (times/day) 3.73.5 A1c (%) 8.4 ± 1.3 8.3 ± 1.0

43. A1c by Group Assignment *p=.03 (SC at baseline vs. SC at year 2) **p=.05 (SC vs. Teamwork at year 1) * **

44. Parental Involvement in BGM Optimal involvement was defined by meeting one of the following criteria: 1) parental involvement increasing, 2) parental involvement staying the same, or 3) parental involvement decreasing moderately if still above the median  ²=4.57, df=1, p=0.03

45. Quality of Life by Group Assignment *p=0.02 (child Teamwork at year 2 vs. child Teamwork at baseline) **p=0.05 (parent Teamwork at year 2 vs. parent Teamwork at baseline) * ** Quality of Life Score

46. Study Group and BGM Frequency Predict Glycemic Control Percent with A1c  8.0% Std. CareTeamwork  3  4 Study Group BGM Frequency (times/day) In a significant multivariate model controlling for gender, age, T1DM duration, and insulin therapy, Teamwork group assignment (P=0.02)* and increased BGM frequency (P=0.001)** were the only significant predictors of achieving A1c  8.0%. * **

47. Summary Teamwork intervention– 1.After 1 yr., HbA1c improved significantly compared with SC at a time when HbA1c usually deteriorates due to intensification of the disease process and  family involvement and  adherence. 2. After 2 yrs., prevented expected deterioration in HbAlc.

48. Summary Teamwork intervention– 3. 3.At 1 yr. and 2 yr.,  family involvement, especially with BGM. 4. At 2 yrs.  in youth quality of life compared with the SC group.

49. To Engage Young Adolescents in Diabetes Management To Engage Young Adolescents in Diabetes Management Set realistic goals –for self-care behavior, for BG, for weight. Avoid perfectionism! Set realistic goals –for self-care behavior, for BG, for weight. Avoid perfectionism! Help Teen and Parent negotiate diabetes care. Help Teen and Parent negotiate diabetes care. To prevent Burn- Out, acknowledge & validate patient’s negative feelings about diabetes; praise all self-care efforts! To prevent Burn- Out, acknowledge & validate patient’s negative feelings about diabetes; praise all self-care efforts! Model to parent how to avoid “shame and blame” language of “good/bad blood sugar” Model to parent how to avoid “shame and blame” language of “good/bad blood sugar”

50. Conclusions  An office-based family-focused teamwork intervention significantly  glycemic control while not  family conflict.  With limited healthcare resources, implementation and evaluation of similar interventions for intensive diabetes management should be considered in the “standard therapy” of youth with T1DM.

51. FMOD is sponsored by the National Institute of Child Health and Human Development (NIHCD) FMOD is sponsored by the National Institute of Child Health and Human Development (NIHCD) Multi-site study involving 4 sites Multi-site study involving 4 sites Coordinating Center and central laboratory Coordinating Center and central laboratory Six-month pilot feasibility study followed by a 2 year intervention trial at all 4 sites Six-month pilot feasibility study followed by a 2 year intervention trial at all 4 sites

52. The Family Management of Diabetes (F-MOD) Trial The Family Management of Diabetes (F-MOD) Trial Multi-site NICHD-funded trial. Multi-site NICHD-funded trial. Largest randomized controlled clinical intervention study of T1DM youth and families: Family-based problem- solving intervention vs. Usual care. Largest randomized controlled clinical intervention study of T1DM youth and families: Family-based problem- solving intervention vs. Usual care. Recruitment began February, 2006. Study duration is 2 years. Recruitment began February, 2006. Study duration is 2 years.

53. Children’s Memorial Hospital Chicago Texas Children’s Hospital Houston Nemours Children’s Clinic Jacksonville Joslin Diabetes Center Boston NICHD and Coordinating Center The FMOD Study is funded by the National Institute of Child Health and Human Development at four clinical sites around the U.S.

54. Summary 1. The “paradox of progress” in 21 st Century: PRO’sCON’s Better tools Increased “burden of Better BG control care” on pts./teams Better BG control care” on pts./teams Lower risk Increased need for Lower risk Increased need for More hope parenting skills training 2. Research on young teens (10 - 14 years) with T1DM indicates that over this period, adherence & parent involvement decline; conflict & HbAlc increase. 2. Research on young teens (10 - 14 years) with T1DM indicates that over this period, adherence & parent involvement decline; conflict & HbAlc increase.

55. Summary 3. Family-focused and clinic-based interventions can prevent the anticipated deterioration in adherence and glycemic control which begin at puberty.

56. Research Collaborators Joslin Team: Joslin Team: Multidisciplinary staff of Joslin Pediatric Unit Multidisciplinary staff of Joslin Pediatric Unit Lori Laffel, MD, chief Lori Laffel, MD, chief Baylor/ Texas Children’s Hospital Team: Baylor/ Texas Children’s Hospital Team: Multidisciplinary staff of TCH Diabetes Care Multidisciplinary staff of TCH Diabetes Care Center, Center, Morey Haymond, MD, chief Morey Haymond, MD, chief Siripoom McKay M.D., Co-Investigator Siripoom McKay M.D., Co-Investigator Wendy Levy, LCSW, Project manager Wendy Levy, LCSW, Project manager