Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth

Обзор

The purpose of this open label trial is to examine the preliminary feasibility, acceptability, and effectiveness of a 12-week behavioral intervention program (1 hour/week) to treat insistence on sameness (e.g., difficulty tolerating changes in routine) in youth with autism spectrum disorder (ASD). Treatment will be delivered via secure telemedicine platform and consist of a combination of parent-training and parent-mediated intervention with the child.

Вмешательства

• Поведенческое Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth
  This is a 12-week intervention program (1 hour/week) of treatment to target insistence on sameness in youth with autism spectrum disorder (ASD). Treatment will be delivered via secure telemedicine platform and consist of combination of parent-training and parent-mediated intervention with the child.

Первичные конечные точки

• Change from Baseline in Insistence on Sameness Subscale of the Dimensional Assessment of Restricted and Repetitive Behaviors (DARB). [Срок оценки: Screening, Baseline, every 2 weeks, 12 weeks, 24 weeks]

Вторичные конечные точки (12)

• Change from Baseline on Blinded Clinician Ratings of Clinical Global Impression Scale, Severity and Improvement Ratings. [Срок оценки: Baseline, 12 weeks]
• Change from Baseline in Parent-Rated Emotion Dysregulation on the Strengths and Difficulties Questionnaire Dysregulation Profile (SDQ-DP) during treatment. [Срок оценки: Baseline, 6 weeks, 12 weeks, 24 weeks]
• Change from Baseline in Parent-Rated Behavioral Inflexibility as captured by the Behavioral Inflexibility Scale. [Срок оценки: Baseline, 6 weeks, 12 weeks, 24 weeks]
• Change from Baseline in Ritualistic/Sameness Subscale of Repetitive Behavior Scale-Revised (RBS-R). [Срок оценки: Baseline, 6 weeks, 12 weeks, 24 weeks]
• Change from Baseline in Parent-Rated Challenging Behaviors on the Open-Source Challenging Behaviors Scale (OS-CBS). [Срок оценки: Baseline, 12 weeks]
• Change from Baseline in Family Accommodation Scale - RRB (FAS-RRB). [Срок оценки: Baseline, 6 weeks, 12 weeks]
• Change from Baseline in Parent-Rated Anxiety as captured by the Anxiety Scale for Children with Autism Spectrum Disorder (ASC-ASD). [Срок оценки: Baseline, 6 weeks, 12 weeks, 24 weeks]
• Change from Baseline in Caregiver Self-Report on the Caregiver Strain Questionnaire Short Form (CGSQ-SF7). [Срок оценки: Baseline, 12 weeks]
• Change from Baseline in the Caregiver Self-Report Depression, Anxiety, and Stress Scale (DASS21). [Срок оценки: Baseline, 12 weeks]
• Caregiver Report Autism Symptoms Dimension Questionnaire (ASDQ). [Срок оценки: Baseline, Week 12]
• Caregiver Report Executive Functioning Scale (EFS). [Срок оценки: Baseline, Week 12]
• Daily Living Skills Scale (DLSS). [Срок оценки: Baseline, Week 12]

Критерии участия

Participants will include children with:

• parent/guardian aged 18 years or older with a child aged between 4.0 to 17.11 years old at the time of parental consent;
• diagnosed with ASD (based on history, review of available medical records including diagnostic testing, e.g., ADOS) or suspicion of ASD diagnosis and confirmed with Autism Diagnostic Interview-Revised (ADI-R);
• parent-reported clinically significant concerns regarding insistence on sameness and behavioral inflexibility;
• stable behavioral and pharmacological treatment for at least two weeks with no anticipated changes;
• English-speaking parent and youth able to consistently participate in study procedures;
• family resides in United States.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• 401 Quarry Road (Remote Study) — Stanford

Идентификаторы

NCT: NCT06362733 · IRB-74165

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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