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Completed

NCT Number: NCT02273310

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

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.

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

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

Registry information

Official study title

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

Acronym: FTC

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Oct 23, 2014
Registry last updated
Jan 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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