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NCT02900144 · ClinicalTrials.gov registry record · NA
Modified Comprehensive Behavioral Intervention for Tics (M_CBIT)
A NA study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 17
- Enrollment target
NCT02900144: Completed NA study, sponsored by Massachusetts General Hospital.
NCT02900144 is a NA study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 17 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02900144, a NA study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 17 participants
- Enrollment target
Study Summary
The main purpose of this trial is to develop and investigate the effects of a modified comprehensive behavioral intervention for tics (CBIT) protocol for children and adolescents with chronic tic disorders and ADHD. CBIT is a first-line behavioral treatment for individuals with tic disorders. However, the benefit of CBIT is mitigated in those with co-occurring ADHD, as ADHD is negatively associated with effect size in behavioral treatments for tics. Additionally, while tic disorders are associated with reduced quality of life measures, CBIT is 'tic-specific.' Despite improving tics, measures do not show associated improved quality of life. Currently, there are no standardized behavioral treatments for tics that account for ADHD symptoms and/or addresses the impact that tics and ADHD symptoms have on quality of life. The first aim is to develop a treatment protocol that combines elements from CBIT, Cognitive Behavioral Therapy (CBT) for ADHD and factors targeting psychosocial impairment. The second aim is to determine the treatment feasibility and acceptability (e.g. retention, reasons for treatment refusal and dropout, and motivation) of this modified CBIT treatment. The investigators will evaluate and assess the randomization process, the treatment modules, and the expectations and satisfaction of the participants and their parents. The final aim is to use a pilot randomized control trial (RCT) design to evaluate improvement using measures including tic, ADHD and quality of life scales as rated by a blinded clinician. Though the investigators will evaluate efficacy of the modified protocol, the primary purpose will remain feasibility. The hope is to use this study to develop larger trials in the future.
Interventions
- BEHAVIORAL Comprehensive Behavioral Intervention for Tics
- BEHAVIORAL Modified Comprehensive Behavioral Intervention for Tics
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2016-09 |
| Est. Completion | 2019-04-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02900144
The ClinicalTrials.gov registry entry for NCT02900144 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Comprehensive Behavioral Intervention for Tics is the first listed.
NCT02900144 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02900144 about?
NCT02900144 is a clinical study titled "Modified Comprehensive Behavioral Intervention for Tics (M_CBIT)". The main purpose of this trial is to develop and investigate the effects of a modified comprehensive behavioral intervention for tics (CBIT) protocol for children and adolescents with chronic tic disorders and ADHD. CBIT is a first-line behavioral treatment for individuals with tic disorders. Howev...
What is the current status of trial NCT02900144?
This trial is currently completed. It is a NA study. The enrollment target is 17 participants. The study started on 2016-09. Estimated completion is 2019-04-10.
What interventions are being tested in trial NCT02900144?
The interventions under investigation include: Comprehensive Behavioral Intervention for Tics (BEHAVIORAL), Modified Comprehensive Behavioral Intervention for Tics (BEHAVIORAL).
Who is sponsoring clinical trial NCT02900144?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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