Families Taking Control (FTC): Family-based Problem-solving Intervention for Children With Sickle Cell Disease

Not Applicable

Completed

• Conditions: Sickle Cell Disease
• Interventions: Behavioral: Problem-Solving Skills Training for Disease Management

• Registration Number: NCT02273310
• Lead Sponsor: University of Pennsylvania

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 Timeline

• Study Start: 2009-07
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Study First Submitted: 2014-10-21
• Study First Submitted QC: 2014-10-21
• Study First Posted: 2014-10-23
• Results First Submitted: 2014-10-29
• Status Verified: 2015-12
• Results First Submitted QC: 2015-12-01
• Last Update Submitted: 2015-12-01
• Results First Posted: 2016-01-07
• Last Update Posted: 2016-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

Inclusion Criteria

English speaking, treated at one of two participating Sickle Cell Centers -

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Exclusion Criteria

severe developmental delay or children/caregivers with severe psychopathology that would adversely affect their ability to participate

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Families Taking Control	Problem-Solving Skills Training for Disease Management	Families participate in a 1 day Problem-Solving Skills training for disease management intervention

Primary Outcome Measures

Name	Time	Method
Child-Reported Health Related Quality of Life-School Functioning Subscale	6 months	Assessed using the Pediatric Quality of Life Inventory, Scores range from 0-100 with higher scores indicating better quality of life.

Secondary Outcome Measures

Name	Time	Method
Acceptability of Intervention	post intervention	Families in the FTC group rated acceptability of participating in the intervention workshop. This measure was completed at the workshop (between baseline and 6 month assessments). This measure utilized a 5-point Likert-type scale (with the possible range of scores as 1-5), with higher scores indicating more positive feedback. Individual item scores are presented here. Participant results indicated a range of scores from from 2-5.
School Functioning-Absences	6 months	School Absences reported by caregivers, Caregivers reported absences categorically (0-7 days = 1, 7-14 days = 2, etc). Higher numbers indicate more absences.
Number of Accommodations Provided to Families by Schools	6 months	Number of Accommodations Provided to Families by Schools As reported by caregivers