Clinical trial NCT00890331: Prevention of Self-care Deterioration in Early Adolescents With Diabetes
Official title: Family Teamwork and Coping Skills Prevention Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 1 Diabetes
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Children's National Research Institute
First posted: 2009-04-29
Enrollment: 285
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Parental involvement and Disease care behaviors
timeFrame: Baseline, (optional 3, 6, and 9 months) 12, 15, 18 and 24 months
Secondary outcomes:
measure: Glycohemoglobin levels, Adverse effects and Blood glucose variability
timeFrame: Baseline, 3, 6, 9, 12, 15, 18, and 24 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Clarissa S Holmes, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's National Research Institute
name: Randi Streisand, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Georgetown University
name: Rusan Chen, Ph.D.
role: STUDY_DIRECTOR
References: