Autism, Autism Spectrum Disorder, Restricted Behavior
Conditions
Keywords
Intervention, Pivotal Response Treatment
Brief summary
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.
Interventions
BEHAVIORALModified 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.
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
Participants will include children with: 1. 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; 2. 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); 3. parent-reported clinically significant concerns regarding insistence on sameness and behavioral inflexibility; 4. stable behavioral and pharmacological treatment for at least two weeks with no anticipated changes; 5. English-speaking parent and youth able to consistently participate in study procedures; 6. family resides in United States.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Insistence on Sameness Subscale of the Dimensional Assessment of Restricted and Repetitive Behaviors (DARB). | Screening, Baseline, every 2 weeks, 12 weeks, 24 weeks | DARB insistence on sameness subscale scores measure insistence on sameness with higher scores indicating greater intensity of insistence on sameness. \[Score Range: 0-76\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline on Blinded Clinician Ratings of Clinical Global Impression Scale, Severity and Improvement Ratings. | Baseline, 12 weeks | 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. |
| Change from Baseline in Parent-Rated Emotion Dysregulation on the Strengths and Difficulties Questionnaire Dysregulation Profile (SDQ-DP) during treatment. | Baseline, 6 weeks, 12 weeks, 24 weeks | SDQ-DP indexes broad emotion dysregulation with higher scores indicating greater intensity of emotion dysregulation. \[Score Range: 1-27\] |
| Change from Baseline in Parent-Rated Behavioral Inflexibility as captured by the Behavioral Inflexibility Scale. | Baseline, 6 weeks, 12 weeks, 24 weeks | The BIS includes 38 items with higher scores indicating greater irritability. \[Score range: 0-190\]. |
| Change from Baseline in Ritualistic/Sameness Subscale of Repetitive Behavior Scale-Revised (RBS-R). | Baseline, 6 weeks, 12 weeks, 24 weeks | Higher scores indicate higher levels of RRBs. \[43 items, 12 in sameness domain\] |
| Change from Baseline in Parent-Rated Challenging Behaviors on the Open-Source Challenging Behaviors Scale (OS-CBS). | Baseline, 12 weeks | 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. \[18 items\] |
| Change from Baseline in Family Accommodation Scale - RRB (FAS-RRB). | Baseline, 6 weeks, 12 weeks | Higher scores indicate higher levels of parental accommodation of insistence on sameness behaviors \[11 items on a 5-point scale to assess frequency of accommodation behaviors\]. |
| Change from Baseline in Parent-Rated Anxiety as captured by the Anxiety Scale for Children with Autism Spectrum Disorder (ASC-ASD). | Baseline, 6 weeks, 12 weeks, 24 weeks | ASC-ASD captures anxiety with higher scores indicating greater anxiety severity across the subdomains of separation anxiety, uncertainty, performance anxiety, and anxious arousal. \[Score Range: 0-72\] |
| Change from Baseline in Caregiver Self-Report on the Caregiver Strain Questionnaire Short Form (CGSQ-SF7). | Baseline, 12 weeks | 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. \[Score Range: 2-10\] |
| Change from Baseline in the Caregiver Self-Report Depression, Anxiety, and Stress Scale (DASS21). | Baseline, 12 weeks | Scores for depression, anxiety, and stress are calculated by summing the scores for the relevant items. \[Scores \> 34 fall in "extremely severe range'\] |
| Caregiver Report Autism Symptoms Dimension Questionnaire (ASDQ). | Baseline, Week 12 | Higher scores indicate greater levels of core autism characteristics. \[Score Range: 0-39\] |
| Caregiver Report Executive Functioning Scale (EFS). | Baseline, Week 12 | 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. \[Score Range: 0-52\] |
| Daily Living Skills Scale (DLSS). | Baseline, Week 12 | Higher scores indicate better ability on the DLSS. \[Score Range: 0-53\] |
Countries
United States
Contacts
CONTACTEmily Ferguson, PhD
CONTACTRobin Libove, BS
PRINCIPAL_INVESTIGATORAntonio Hardan, MD
Stanford University
Outcome results
None listed