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Prevention of Self-care Deterioration in Early Adolescents With Diabetes

Family Teamwork and Coping Skills Prevention Program

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00890331
Enrollment
285
Registered
2009-04-29
Start date
2007-04-30
Completion date
2014-03-31
Last updated
2016-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Brief summary

Establish the efficacy of a brief, clinic-based prevention program of teamwork coping skills for youth and their parents during in a high risk period of early adolescence (11-14 yrs) when parental involvement and self-care deterioration occurs.

Detailed description

Promotion of optimal disease care and metabolic control in youth with Type 1 diabetes is an important goal of disease management during early adolescence. Typically youth assume increasing responsibility for these goals along with parental involvement and guidance. However, as youth progress through adolescence, parents often become less involved in diabetes management and poorer self-care and metabolic control often results. The goal of the prevention program is to encourage parents to remain involved in their child's diabetes care throughout adolescence and to provide tools to help make that involvement a positive experience. To minimize parent/child conflict that may accompany sustained parental involvement, sessions of the active treatment review the following coping skills: communication, problem solving, conflict resolution, attitude and behavior change. Meetings occur in-clinic in conjunction with four consecutive medical appointments. The educational comparison group also meets with study researchers for in-clinic sessions that occur in conjunction with four consecutive medical appointments. Families discuss a variety of helpful educational diabetes topics and resources. The overarching project goal is to demonstrate the efficacy of a brief, prevention focused coping skills program for youth with type 1 diabetes and their parents with the ultimate goal of translation into routine pediatric care.

Interventions

BEHAVIORALTeamWork CS Sessions

The intervention focuses on an authoritative parenting approach that emphasizes continued parental involvement in daily disease care. Dyadic coping skills of communication, problem solving, conflict resolution, along with attitude and behavior change are highlighted. Families meet with a study interventionist in conjunction with four consecutive medical appointments.

BEHAVIORALDiabetes Education

Diabetes Education The education comparison group meets with an educational interventionist in conjunction with four consecutive medical appointments. This group focuses on diabetes educational and resource support for parents and their youth with type 1 diabetes.

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
Children's National Research Institute
CollaboratorOTHER
Virginia Commonwealth University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
11 Years to 14 Years
Healthy volunteers
No

Inclusion criteria

* Seen for Diabetes care at Virginia Commonwealth University or Children's National Medical Center * Child ages 11-14 * Type 1 Diabetes * Fluent in English * Ability to comprehend and complete questionnaires independently

Exclusion criteria

* The presence of any other major disease * The presence of any severe diabetic complications which could impair test performance * Use of any medication that affects the CNS other than insulin * Inability to speak/comprehend and read English * Placement in special classes for the mentally disabled

Design outcomes

Primary

MeasureTime frame
Parental involvement and Disease care behaviorsBaseline, (optional 3, 6, and 9 months) 12, 15, 18 and 24 months

Secondary

MeasureTime frame
Glycohemoglobin levels, Adverse effects and Blood glucose variabilityBaseline, 3, 6, 9, 12, 15, 18, and 24 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026