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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: Completed NA study, sponsored by Children's National Research Institute.

NCT04388241 is a NA study that has completed, run by Children's National Research Institute. The registered enrollment target is 22 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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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).

Primary Outcome

Feasibility will be determined by examining the proportion of participants (e.g., 80%) that complete all four sessions.

Interventions

  • BEHAVIORAL The Balance Program

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2020-09-23
Est. Completion 2022-08-04
Phase NA

What the finished NCT04388241 record still lists

NCT04388241 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which The Balance Program is the first listed.

NCT04388241 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT04388241's enrollment target sits among peer trials

22 1756th of 2000 higher than 239 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04388241, the US trial registry maintained by the National Library of Medicine. NCT04388241 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.