Clinical trial NCT06472115: Parent-Mediated Intervention Targeting Insistence on Sameness for Autistic Children
Official title: A Pilot Telehealth Parent-Mediated Intervention Targeting Insistence on Sameness for Autistic Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Autism
Keywords: Supportive Parenting for Anxious Childhood emotions (SPACE)
Restricted Behavior
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will examine the potential effectiveness of a virtually delivered parent-mediated intervention for insistence on sameness behaviors in autism and investigate 1) whether caregivers can learn to deliver the adapted Supportive Parenting for Anxious Childhood emotions (SPACE) intervention for IS via telehealth and 2) whether children will show greater improvement in IS behaviors.


Eligibility criteria: Inclusion Criteria:

* 6:0 to 10:11 years at the time of consent
* diagnosed with ASD (based on history, review of available medical records including diagnostic testing completed by psychologist)
* IQ \> or = 75 (based on history, review of available medical records)
* report three or more family accommodations for insistence on sameness based on screening measures
* English-speaking parent and youth able to consistently participate in study procedures

Exclusion Criteria:

* children with significant hearing, language or motor impairment
* unstable behavioral and pharmacological treatments (e.g., anxiety medication) to treat anxiety or IS behaviors prior to two months to the start of the study and no anticipated changes in treatments during the course of the trial
* caregivers who have participated in formal SPACE training
* concurrent psychosocial treatment for anxiety or Insistence on Sameness
* children who have a history of prominent school refusal, self-harm, or suicidal ideation

Primary outcomes:
measure: Change from baseline in parent rated Dimensional Assessment of Restricted Behavior (DARB) Scores during treatment.
timeFrame: Screening, Baseline, Weeks 4, 8, 12, 16 and 2 month follow up
measure: Change from baseline in clinician rated clinical global impressions scale scores during treatment.
timeFrame: Weeks 8, 16 and 2 month follow up
Secondary outcomes:
measure: Change from Baseline in Parent-Rated Anxiety as captured by the Anxiety Scale for Children with Autism Spectrum Disorder (ASC-ASD).
timeFrame: Baseline, Week 16 and 2 month Follow up
measure: Change in Emotion Regulation Checklist scores during treatment
timeFrame: Baseline, 16 week
measure: Change in Daily Living Skills Scale Scores during treatment
timeFrame: Baseline, 16 week, 2 month Follow up
measure: Change in Open Source - Challenging Behavior scores during treatment
timeFrame: Baseline, 16 weeks, 2 month Follow Up
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Jennifer Phillips
state: California
Study officials:
affiliation: Stanford University
name: Jennifer Phillips, PhD
role: PRINCIPAL_INVESTIGATOR
References: