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

• ClinicalTrials.gov Identifier: NCT02273310
• Recruitment Status: Completed
• First Posted: October 23, 2014
• Results First Posted: January 7, 2016
• Last Update Posted: January 7, 2016
• Sponsor: University of Pennsylvania
• Collaborators: Drexel University; National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): University of Pennsylvania

Tracking Information

• First Submitted Date: October 21, 2014
• First Posted Date: October 23, 2014
• Results First Submitted Date: October 29, 2014
• Results First Posted Date: January 7, 2016
• Last Update Posted Date: January 7, 2016
• Study Start Date: July 2009
• Actual Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 1, 2015)

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.

• Original Primary Outcome Measures (submitted: October 21, 2014): Health Related Quality of Life [ Time Frame: 6 months ]

Current Secondary Outcome Measures (submitted: December 1, 2015)

• School Functioning-Absences [ Time Frame: 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 [ Time Frame: 6 months ]
  Number of Accommodations Provided to Families by Schools As reported by caregivers
• Acceptability of Intervention [ Time Frame: 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.

Original Secondary Outcome Measures (submitted: October 21, 2014)

• Parent Problem Solving [ Time Frame: 6 months ]
• School Functioning [ Time Frame: 6 months ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Families Taking Control (FTC): Family-based Problem-solving Intervention for Children With Sickle Cell Disease
• Official Title: Families Taking Control (FTC): Family-based Problem-solving Intervention for School-age Children With Sickle Cell Disease
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: 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.

Study Arms

• Experimental: Families Taking Control
  Families participate in a 1 day Problem-Solving Skills training for disease management intervention
  Intervention: Behavioral: Problem-Solving Skills Training for Disease Management
• No Intervention: Delayed Intervention Control
  Families are given the opportunity to complete the Problem-solving Skills training for disease management intervention after assessment time 2.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 21, 2014): 83
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: August 2012
• Actual Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

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Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Years to 12 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02273310
• Other Study ID Numbers: U54HL070585( U.S. NIH Grant/Contract ); U54HL070585 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of Pennsylvania
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Pennsylvania
• Original Study Sponsor: Same as current

Collaborators

• Drexel University
• National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Lamia Barakat, Ph.D.; The Children's Hospital of Philadelphia/University of Pennsylvania

• PRS Account: University of Pennsylvania
• Verification Date: December 2015