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 : Recruiting
First Posted : May 14, 2020
Last Update Posted : January 27, 2021
|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|
|Actual Study Start Date :||September 23, 2020|
|Estimated Primary Completion Date :||August 31, 2021|
|Estimated Study Completion Date :||August 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04388241
|Contact: Megan Connolly, PhD||2024765599||MConnoll@childrensnational.org|
|United States, District of Columbia|
|Children's National Hospital||Recruiting|
|Washington, District of Columbia, United States, 20010|
|Contact: Megan Connolly, PhD 202-476-5599 MConnoll@childrensnational.org|
|Principal Investigator:||Megan Connolly||Children's National Research Institute|