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

Sickle Cell Disease Clinical Trial

— FTC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02273310
• Other study ID #: U54HL070585
• Secondary ID: U54HL070585
• Status: Completed
• Phase: N/A
• First received: October 21, 2014
• Last updated: December 1, 2015
• Start date: July 2009
• Est. completion date: August 2012

Study information

• Verified date: December 2015
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Behavioral:
• Problem-Solving Skills Training for Disease Management
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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	Drexel University, National Heart, Lung, and Blood Institute (NHLBI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Number of Accommodations Provided to Families by Schools	Number of Accommodations Provided to Families by Schools As reported by caregivers	6 months	No
Secondary	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	No