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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

Tracking Information
First Submitted Date  ICMJE October 21, 2014
First Posted Date  ICMJE October 23, 2014
Results First Submitted Date  ICMJE October 29, 2014
Results First Posted Date  ICMJE January 7, 2016
Last Update Posted Date January 7, 2016
Study Start Date  ICMJE July 2009
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (submitted: October 21, 2014)
Health Related Quality of Life [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Families Taking Control (FTC): Family-based Problem-solving Intervention for Children With Sickle Cell Disease
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Sickle Cell Disease
Intervention  ICMJE 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 21, 2014)
83
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02273310
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Current Responsible Party University of Pennsylvania
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Pennsylvania
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Drexel University
  • National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Lamia Barakat, Ph.D. The Children's Hospital of Philadelphia/University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP