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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sickle Cell Disease

Intervention / Treatment
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* Behavioral: Problem-Solving Skills Training for Disease Management


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Families Taking Control<br>Families participate in a 1 day Problem-Solving Skills training for disease management intervention | Behavioral: Problem-Solving Skills Training for Disease Management<br>* Children and caregivers participated in a multi-family group to learn problem-solving skills as applied to disease management and school functioning in the context of sickle cell disease.<br>|
| No Intervention: Delayed Intervention Control<br>Families are given the opportunity to complete the Problem-solving Skills training for disease management intervention after assessment time 2. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| School Functioning-Absences | School Absences reported by caregivers, Caregivers reported absences categorically (0-7 days = 1, 7-14 days = 2, etc). Higher numbers indicate more absences. | 6 months | 
| Number of Accommodations Provided to Families by Schools | Number of Accommodations Provided to Families by Schools As reported by caregivers | 6 months | 
| Acceptability of 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. | post intervention |