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

NCT02273310 | Completed Results

• 1 other identifier: U54HL070585
• Study Type: interventional
• Target: 83
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• School Functioning-Absences

  6 months

• Number of Accommodations Provided to Families by Schools

  6 months

• Acceptability of Intervention

  post intervention

Study Arms (2)

Families Taking Control

EXPERIMENTAL

Families participate in a 1 day Problem-Solving Skills training for disease management intervention

Behavioral: Problem-Solving Skills Training for Disease Management

Delayed Intervention Control

NO INTERVENTION

Families are given the opportunity to complete the Problem-solving Skills training for disease management intervention after assessment time 2.

Interventions

Problem-Solving Skills Training for Disease Management BEHAVIORAL

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.

Families Taking Control

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

Sponsors & Collaborators

• University of Pennsylvania: lead
• Drexel University: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Disease Management

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Patient Care Management; Health Services Administration

Results Point of Contact

• Title: Lamia Barakat, Ph.D.
• Organization: The Children's Hospital of Philadelphia/Perleman School of Medicine of The University of Pennsylvania

barakat@email.chop.edu

267-426-8135

Study Officials

• Lamia Barakat, Ph.D.

  The Children's Hospital of Philadelphia/University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2014
• First Posted: October 23, 2014
• Study Start: July 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: January 7, 2016
• Results First Posted: January 7, 2016

Record last verified: 2015-12