Modified Comprehensive Behavioral Intervention for Tics: Treating Children With Tic Disorders, Co-occurring ADHD and Psychosocial Impairment (M_CBIT)

NCT02900144 NA COMPLETED

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.

Details

Lead sponsor	Massachusetts General Hospital
Phase	NA
Status	COMPLETED
Enrolment	17
Start date	2016-09
Completion	2019-04-10

Conditions

• Tourette Syndrome
• ADHD

Interventions

• Modified Comprehensive Behavioral Intervention for Tics
• Comprehensive Behavioral Intervention for Tics

Primary outcomes

• Patient Satisfaction Questionnaire — 26 weeks
  Scale that measures the subject's satisfaction with the treatment
• Expectancy Therapy Evaluation Form — Baseline
  Rates subject's expectations about effectiveness of the treatment
• Satisfaction Scale for Module 1 — 1 week
  Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.
• Expectancy Therapy Evaluation Form — 6 weeks
  Rates subject's expectations about effectiveness of the treatment
• Satisfaction Scale for Module 2 — 2 weeks
  Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.
• Satisfaction Scale for Module 3 — 3 weeks
  Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.

Countries

United States