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

NCT ID: NCT02273310

Last Updated: 2016-01-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2012-08-31

Brief Summary

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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

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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.

Conditions

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Sickle Cell Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Families Taking Control

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

Group Type EXPERIMENTAL

Problem-Solving Skills Training for Disease Management

Intervention Type 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.

Delayed Intervention Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Drexel University

OTHER

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lamia Barakat, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The Children's Hospital of Philadelphia/University of Pennsylvania

Other Identifiers

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U54HL070585

Identifier Type: NIH

Identifier Source: secondary_id

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U54HL070585

Identifier Type: NIH

Identifier Source: org_study_id

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