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Modified Comprehensive Behavioral Intervention for Tics (M_CBIT)

NCT02900144 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2021-09-16

No results posted yet for this 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.

Conditions

  • Tourette Syndrome
  • ADHD

Interventions

BEHAVIORAL

Modified Comprehensive Behavioral Intervention for Tics

In this arm, participants will receive the modified CBIT protocol. In addition to addressing tics, the treatment in this arm will also directly address ADHD symptoms using CBT for ADHD techniques, and quality of life concerns. The treatment itself will be modified to be more accessible to an ADHD population. The treatment will consist of twelve 50-min sessions: ten weekly and then two every other week for relapse prevention.

BEHAVIORAL

Comprehensive Behavioral Intervention for Tics

In this arm, participants will receive the standard CBIT intervention (Piacentini et al 2010). The primary components of CBIT are habit reversal training, relaxation training and a functional interventional to assess the environment for situations/factors that exacerbate or sustain tics. The treatment will consist of twelve 50-min sessions: ten weekly and then two every other week for relapse prevention.

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2019-04-10
Completion
2019-04-10

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02900144 on ClinicalTrials.gov