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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote (Telehealth) Intervention Program | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Insistence on Sameness Subscale of the Dimensional Assessment of Restricted and Repetitive Behaviors (DARB). | DARB insistence on sameness subscale scores measure insistence on sameness with higher scores indicating greater intensity of insistence on sameness. [Score Range: 0-76] | Screening, Baseline, every 2 weeks, 12 weeks, 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline on Blinded Clinician Ratings of Clinical Global Impression Scale, Severity and Improvement Ratings. | Score Range: 1 = normal, not at all ill; 7 = among the most extremely ill patients; 1 = very much informed since the initiation of treatment; 7 = very much worse since the initiation of treatment. | Baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Social Validity Measures | Caregivers will complete a survey and interview post-intervention to assess feasibility, acceptability, and satisfaction with the intervention. | Week 12 |
Participants will include children with:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emily Ferguson, PhD | Contact | 650-736-1235 | eferguso@stanford.edu | |
| Robin Libove, BS | Contact | 650-736-1235 | rlibove@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Antonio Hardan, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 401 Quarry Road (Remote Study) | Recruiting | Stanford | California | 94305 | United States |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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|
| Change from Baseline in Parent-Rated Emotion Dysregulation on the Strengths and Difficulties Questionnaire Dysregulation Profile (SDQ-DP) during treatment. |
SDQ-DP indexes broad emotion dysregulation with higher scores indicating greater intensity of emotion dysregulation. [Score Range: 1-27] |
| Baseline, 6 weeks, 12 weeks, 24 weeks |
| Change from Baseline in Parent-Rated Behavioral Inflexibility as captured by the Behavioral Inflexibility Scale. | The BIS includes 38 items with higher scores indicating greater irritability. [Score range: 0-190]. | Baseline, 6 weeks, 12 weeks, 24 weeks |
| Change from Baseline in Ritualistic/Sameness Subscale of Repetitive Behavior Scale-Revised (RBS-R). | Higher scores indicate higher levels of RRBs. [43 items, 12 in sameness domain] | Baseline, 6 weeks, 12 weeks, 24 weeks |
| Change from Baseline in Parent-Rated Challenging Behaviors on the Open-Source Challenging Behaviors Scale (OS-CBS). | The OS-CBS captures the severity of categories of challenging behaviors, including property destruction, aggression, elopement, conduct problems, and self-injurious behaviors, with the option to calculate a total score for each subscale and total challenging behavior, with higher score averages indicating higher severity. [18 items] | Baseline, 12 weeks |
| Change from Baseline in Family Accommodation Scale - RRB (FAS-RRB). | Higher scores indicate higher levels of parental accommodation of insistence on sameness behaviors [11 items on a 5-point scale to assess frequency of accommodation behaviors]. | 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). | ASC-ASD captures anxiety with higher scores indicating greater anxiety severity across the subdomains of separation anxiety, uncertainty, performance anxiety, and anxious arousal. [Score Range: 0-72] | Baseline, 6 weeks, 12 weeks, 24 weeks |
| Change from Baseline in Caregiver Self-Report on the Caregiver Strain Questionnaire Short Form (CGSQ-SF7). | The CGSQ-SF7 assesses additional demands, pressures, and responsibilities in families with youths suffering from behavioral or emotional disorders, with higher scores indicating greater strain. [Score Range: 2-10] | Baseline, 12 weeks |
| Change from Baseline in the Caregiver Self-Report Depression, Anxiety, and Stress Scale (DASS21). | Scores for depression, anxiety, and stress are calculated by summing the scores for the relevant items. [Scores > 34 fall in "extremely severe range'] | Baseline, 12 weeks |
| Caregiver Report Autism Symptoms Dimension Questionnaire (ASDQ). | Higher scores indicate greater levels of core autism characteristics. [Score Range: 0-39] | Baseline, Week 12 |
| Caregiver Report Executive Functioning Scale (EFS). | The EFS characterizes sequencing/working memory, response inhibition, set shifting, emotion regulation, and risk-taking facets of executive functioning. Higher scores indicate better executive functioning. [Score Range: 0-52] | Baseline, Week 12 |
| Daily Living Skills Scale (DLSS). | Higher scores indicate better ability on the DLSS. [Score Range: 0-53] | Baseline, Week 12 |