Preliminary Feasibility and Efficacy of Behavioral Intervention to Reduce Pain-Related Disability in Pediatric SCD
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|ClinicalTrials.gov Identifier: NCT04388241|
Recruitment Status : Not yet recruiting
First Posted : May 14, 2020
Last Update Posted : May 14, 2020
Children's National Research Institute
Information provided by (Responsible Party):
Megan Connolly, Children's National Research Institute
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).
|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Disease Pain||Behavioral: The Balance Program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Preliminary Feasibility and Efficacy of The Balance Program to Reduce the Impact of Pain on Daily Functioning in Pediatric Sickle Cell Disease|
|Estimated Study Start Date :||June 1, 2020|
|Estimated Primary Completion Date :||May 31, 2021|
|Estimated Study Completion Date :||May 31, 2021|
Experimental: Behavioral Intervention
Children and adolescents with SCD between the ages of 8 and 17 years old (n=20) will be recruited to complete a four-week behavioral intervention designed to reduce pain-related impairment in SCD.
Behavioral: The Balance Program
The Balance Program is a four-week behavioral intervention (each session lasting 60 minutes) developed specifically for the pediatric SCD population based on existing evidence-based treatments to target the unique presentation of pain-related disability in SCD.
Primary Outcome Measures :
- Feasibility assessed by program completion rates [ Time Frame: Following the completion of the intervention (5 weeks from baseline) ]Feasibility will be determined by examining the proportion of participants (e.g., 80%) that complete all four sessions.
- Acceptability assessed by satisfaction ratings and report [ Time Frame: Following the completion of the intervention (5 weeks from baseline) ]Acceptability will be determined by examining the satisfaction with the treatment on the Treatment Evaluation Inventory (TEI) (i.e., >80% reporting at least a "moderate" acceptability on the TEI) as well as through analysis of qualitative interviews.
- Preliminary efficacy of the intervention in changing pain-related outcomes [ Time Frame: Following the completion of the intervention (5 weeks from baseline, 1-month follow up, 3-month follow up)) ]Efficacy will be determined by examining self- and parent-reported changes in pain-related disability and behaviors at post-intervention and one- and three- month follow-up compared to baseline
- Preliminary efficacy of the intervention in changing pain-related outcomes as measured by medication use [ Time Frame: Following the completion of the intervention (5 weeks from baseline, 1-month follow up, 3-month follow up)) ]Efficacy will also be determined by examining changes in opioid use, as measured by number of prescriptions filled and self-reported use, at post-intervention and one- and three- month follow-up compared to baseline.
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