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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Collaborators:
Drexel University
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Pennsylvania

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Behavioral: Problem-Solving Skills Training for Disease Management Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Families Taking Control (FTC): Family-based Problem-solving Intervention for School-age Children With Sickle Cell Disease
Study Start Date : July 2009
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Family Issues

Arms and Interventions
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Arm Intervention/treatment
Experimental: Families Taking Control
Families participate in a 1 day Problem-Solving Skills training for disease management 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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. Number of Accommodations Provided to Families by Schools [ Time Frame: 6 months ]
    Number of Accommodations Provided to Families by Schools As reported by caregivers

  3. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02273310


Sponsors and Collaborators
University of Pennsylvania
Drexel University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Lamia Barakat, Ph.D. The Children's Hospital of Philadelphia/University of Pennsylvania
More Information
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02273310    
Other Study ID Numbers: U54HL070585 ( U.S. NIH Grant/Contract )
U54HL070585 ( U.S. NIH Grant/Contract )
First Posted: October 23, 2014    Key Record Dates
Results First Posted: January 7, 2016
Last Update Posted: January 7, 2016
Last Verified: December 2015
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn