Families Taking Control (FTC): Family-based Problem-solving Intervention for Children With Sickle Cell Disease (FTC)
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|ClinicalTrials.gov Identifier: NCT02273310|
Recruitment Status : Completed
First Posted : October 23, 2014
Results First Posted : January 7, 2016
Last Update Posted : January 7, 2016
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|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Disease||Behavioral: Problem-Solving Skills Training for Disease Management||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||83 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
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|Ages Eligible for Study:||6 Years to 12 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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
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
|Principal Investigator:||Lamia Barakat, Ph.D.||The Children's Hospital of Philadelphia/University of Pennsylvania|
|Responsible Party:||University of Pennsylvania|
|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|
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn