Comprehensive Behavioral Intervention for Tics

Официальное название

Comprehensive Behavioral Intervention for Tics (CBIT) for Youth With Tics and Related Emotional Disorders

Обзор

The purpose of this protocol is to examine treatment outcomes of youth receiving the Comprehensive Behavioral Intervention for Tics (CBIT) and better understand the predictors, moderators, mediators and/or mechanisms of change for this intervention.

Вмешательства

• Поведенческое Comprehensive Behavioral Intervention for Tics (CBIT)
  The CBIT (or CBIT-JR) intervention consists of a minimum of 6 sessions of 50-minutes each week in an individual or group setting.

Первичные конечные точки

• Clinical Global Impression (CGI) - Severity Scale Scores [Срок оценки: Change from baseline CGI-S scores to 12 weeks.]
• Clinical Global Impression (CGI) - Improvement Scores [Срок оценки: Change from baseline CGI-I scores to 12 weeks from the start of treatment.]
• Parent Tic Questionnaire (PTQ) [Срок оценки: Change from pre-screen PTQ scores, to baseline, to 6 weeks, and 12 weeks from the start of treatment.]
• Premonitory Urge Tic Scale (PUTS) [Срок оценки: Change from baseline PUTS scores, to 6 weeks, to 12 weeks from the start of treatment.]
• Youth Quality of Life (YQOL) Instrument - Short Form (SF) Scores [Срок оценки: Change from baseline YQOL Scores, to 6 weeks, to 12 weeks from the start of treatment.]
• Yale Global Tic Severity Scale (YGTSS) - Total Tic Scores [Срок оценки: Change from pre-screen YGTSS Total Tic Scores, to 6 weeks, and 12 weeks from the start of treatment.]
• Yale Global Tic Severity Scale (YGTSS) - Total Motor Tic Scores [Срок оценки: Change from pre-screen YGTSS Total Motor Tic Scores, to 6 weeks, and 12 weeks from the start of treatment.]
• Yale Global Tic Severity Scale (YGTSS) - Total Phonic Tic Score [Срок оценки: Change from pre-screen YGTSS Total Phonic Tic Scores, to 6 weeks, and 12 weeks from the start of treatment.]
• Yale Global Tic Severity Scale (YGTSS) - Overall Tic Related Impairment Scores [Срок оценки: Change from YGTSS Overall Tic Related Impairment Scores pre-screen, to 6 weeks, and 12 weeks from the start of treatment.]
• Yale Global Tic Severity Scale (YGTSS) - Global Severity Score [Срок оценки: Change from pre-screen YGTSS Global Severity Score, to 6 weeks, and 12 weeks from the start of treatment.]

Вторичные конечные точки (2)

• Revised Children's Anxiety and Depression Scale - Child and Revised Parent Short (RCADS-25/RCADS-P-25) Scores [Срок оценки: Change from baseline RCADS-P scores, to 6 weeks, to 12 weeks from the start of treatment.]
• Tic Accommodation and Reactions Scale (TARS) Scores [Срок оценки: Change from baseline TARS scores, to 6 weeks, to 12 weeks from the start of treatment.]

Критерии участия

Критерии включения

• A current diagnosis of a Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Tic disorder (e.g., Tourette's Disorder/syndrome, Persistent (Chronic) Motor or Vocal Tic Disorder, or Provisional Tic Disorder) or caregiver/youth report of clinically impairing tic symptoms
• Ability for youth to speak/read English sufficiently
• At least one parent/caregiver available to sign study consent forms, remain present during assessments, and fill out study questionnaires in English.

Критерии исключения

• A current diagnosis of psychosis, bipolar disorder, intellectual disability, acute suicidality, alcohol/substance dependence, or eating disorder.
• Youth currently receiving psychotherapy elsewhere and/or have previously received CBIT.
• Currently suicidal or who have engaged in suicidal behaviors within the past 6 months will be excluded
• Youth currently taking psychotropic medication for a co-morbid psychiatric illness will be included without a wash-out period (to not delay treatment).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Miami — Coral Gables

Идентификаторы

NCT: NCT05370391 · 20210853

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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