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NCT04388241 · ClinicalTrials.gov registry record · NA
Preliminary Feasibility and Efficacy of Behavioral Intervention to Reduce Pain-Related Disability in Pediatric SCD
A NA study, sponsored by Children's National Research Institute.
- Completed
- Registry status
- NA
- Development phase
- 22
- Enrollment target
NCT04388241 is a NA study that has completed, run by Children's National Research Institute. The registered enrollment target is 22 participants.
The verdict
NCT04388241, a NA study, has completed, sponsored by Children's National Research Institute.
- COMPLETED
- Registry status
- NA
- Development phase
- 22 participants
- Enrollment target
Study Summary
Pain is the primary complication of sickle cell disease (SCD), including vaso-occlusive crises and more persistent, chronic pain. SCD-related pain is associated with significant functional impairment, spanning poor school attendance, decreased quality of life, and stress and mood difficulties. Pharmacological approaches are the first-line treatment for SCD-related pain, but these can be costly and have unwanted side effects. Given limitations from pharmacological approaches and the influence that poor behavioral responses have on disease management and health outcomes suggest a critical need for alternative and adjunctive treatments. Due to gaps in available behavioral treatments specifically designed for addressing common challenges associated with pain management in pediatric SCD, the investigators developed a manualized behavioral therapy protocol by tailoring existing evidence-based treatments. The overall goal of the intervention is to reduce the impact of pain on daily functioning in pediatric SCD. This study will empirically test the feasibility and preliminary efficacy of this intervention for youth with SCD. Children and adolescents with SCD between the ages of 8 and 17 years old (n=20) will be recruited to complete the treatment protocol. Feasibility will be assessed by examining participation and program completion rates, as well as feedback from a treatment acceptability questionnaire and qualitative interview. Participants will complete baseline assessments, weekly questionnaires, and post-treatment assessments (post-intervention assessment, follow-up time points: 1-month following the intervention, and 3-months following the intervention).
Interventions
- BEHAVIORAL The Balance Program
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2020-09-23 |
| Est. Completion | 2022-08-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04388241
The ClinicalTrials.gov registry entry for NCT04388241 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's National Research Institute, which has 92 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which The Balance Program is the first listed.
NCT04388241 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04388241 about?
NCT04388241 is a clinical study titled "Preliminary Feasibility and Efficacy of Behavioral Intervention to Reduce Pain-Related Disability in Pediatric SCD". Pain is the primary complication of sickle cell disease (SCD), including vaso-occlusive crises and more persistent, chronic pain. SCD-related pain is associated with significant functional impairment, spanning poor school attendance, decreased quality of life, and stress and mood difficulties. Pharm...
What is the current status of trial NCT04388241?
This trial is currently completed. It is a NA study. The enrollment target is 22 participants. The study started on 2020-09-23. Estimated completion is 2022-08-04.
What interventions are being tested in trial NCT04388241?
The interventions under investigation include: The Balance Program (BEHAVIORAL).
Who is sponsoring clinical trial NCT04388241?
This trial is sponsored by Children's National Research Institute, which has 92 total clinical trials registered on ClinicalTrials.gov.
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