Families Taking Control (FTC): Family-based Problem-solving Intervention for School-age Children With Sickle Cell Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pennsylvania
- Enrollment
- 83
- Primary Endpoint
- Child-Reported Health Related Quality of Life-School Functioning Subscale
Study Overview
Brief Summary
This study aims to develop an effective, brief, family-based intervention targeting quality of life and school functioning for youth with sickle cell disease. Utilizing a randomized, delayed control group intervention methodology, the present study will systematically document the effectiveness of a family-based, one-day intervention plus booster phone calls to improve quality of life and increase school functioning for children with sickle cell disease transitioning to school and their families.
Detailed Description
Families Taking Control-School-age Intervention (FTC) will provide education and problem solving training for disease management and school functioning. In 4 sessions offered over the course of one day, families (patient, caregivers, and school-age siblings) will work together and individually to learn and apply the problem solving skills training model to relevant examples and family-specific problems, culminating in an outline of family goals to target after the intervention. The three booster phone calls will provide support to families in implementing the problem-solving model by addressing and refining goals and trouble-shooting barriers to implementation. Children and caregivers completed measures at baseline (prior to intervention participation) and 6 months later.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •English speaking, treated at one of two participating Sickle Cell Centers -
Exclusion Criteria
- •severe developmental delay or children/caregivers with severe psychopathology that would adversely affect their ability to participate
Arms & Interventions
Families Taking Control
Families participate in a 1 day Problem-Solving Skills training for disease management intervention
Intervention: Problem-Solving Skills Training for Disease Management (Behavioral)
Delayed Intervention Control
Families are given the opportunity to complete the Problem-solving Skills training for disease management intervention after assessment time 2.
Outcomes
Primary Outcomes
Child-Reported Health Related Quality of Life-School Functioning Subscale
Time Frame: 6 months
Assessed using the Pediatric Quality of Life Inventory, Scores range from 0-100 with higher scores indicating better quality of life.
Secondary Outcomes
- School Functioning-Absences(6 months)
- Acceptability of Intervention(post intervention)
- Number of Accommodations Provided to Families by Schools(6 months)