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 : Completed
First Posted : May 14, 2020
Last Update Posted : September 6, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Disease Pain||Behavioral: The Balance Program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 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|
|Actual Primary Completion Date :||June 22, 2022|
|Actual Study Completion Date :||August 4, 2022|
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.
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|Ages Eligible for Study:||8 Years to 17 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Children and adolescents with SCD (HbSS, HbSC, HbS-beta0 thalassemia, or HbS-beta+ thalassemia) between the ages of 8 and 17 years old with pain-related disability and who are currently prescribed short- or long-acting opioid medications.
- Participants will meet at least one of the following criteria for pain-related disability: 1) Have had at least 3 pain crises in the last year, 2) Have had at least one admission for pain in the last year, or 3) Have missed at least one week of school (5 days) in the last year
- Current prescription of opioids will be confirmed by participants' primary hematologist, review of the electronic medical record, and discussion with the family.
- Patients and caregivers with limited English proficiency, a neurodevelopmental delay, or a visual or motor impairment that would interfere with their ability to complete the assessments and intervention.
- Documented history of major depressive disorder in medical record and/or through discussion with their primary hematology suggesting that patients may need a specific and higher level of therapeutic care.
- Patients have regularly scheduled outpatient therapy sessions outside of the study.
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
|United States, District of Columbia|
|Children's National Hospital|
|Washington, District of Columbia, United States, 20010|
|Principal Investigator:||Megan Connolly||Children's National Research Institute|
|Responsible Party:||Megan Connolly, PhD; Assistant Professor of Pediatrics and Psychiatry & Behavioral Sciences, Children's National Research Institute|
|Other Study ID Numbers:||
|First Posted:||May 14, 2020 Key Record Dates|
|Last Update Posted:||September 6, 2022|
|Last Verified:||September 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn