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Clinical Trials/NCT06472115
NCT06472115
Recruiting
N/A

A Pilot Telehealth Parent-Mediated Intervention Targeting Insistence on Sameness for Autistic Children

Stanford University1 site in 1 country30 target enrollmentJanuary 5, 2025

Overview

Phase
N/A
Intervention
Supportive Parenting for Anxious Childhood Emotions (SPACE) for insistence on sameness (IS)
Conditions
Autism Spectrum Disorder
Sponsor
Stanford University
Enrollment
30
Locations
1
Primary Endpoint
Change from baseline in parent rated Dimensional Assessment of Restricted Behavior (DARB) Scores during treatment.
Status
Recruiting
Last Updated
2 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 5, 2025
End Date
October 1, 2027
Last Updated
2 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jennifer Phillips

Professor of Psychiatry and Behavioral Sciences

Stanford University

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

Arms & Interventions

Active treatment

Eligible participants that enroll will received 16 week parent based intervention for insistence on sameness

Intervention: Supportive Parenting for Anxious Childhood Emotions (SPACE) for insistence on sameness (IS)

Outcomes

Primary Outcomes

Change from baseline in parent rated Dimensional Assessment of Restricted Behavior (DARB) Scores during treatment.

Time Frame: Screening, Baseline, Weeks 4, 8, 12, 16 and 2 month follow up

DARB scores measure restricted and repetitive behaviors with higher scores indicating greater intensity.

Change from baseline in clinician rated clinical global impressions scale scores during treatment.

Time Frame: Weeks 8, 16 and 2 month follow up

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.

Secondary Outcomes

  • Change from Baseline in Parent-Rated Anxiety as captured by the Anxiety Scale for Children with Autism Spectrum Disorder (ASC-ASD).(Baseline, Week 16 and 2 month Follow up)
  • Change in Emotion Regulation Checklist scores during treatment(Baseline, 16 week)
  • Change in Daily Living Skills Scale Scores during treatment(Baseline, 16 week, 2 month Follow up)
  • Change in Open Source - Challenging Behavior scores during treatment(Baseline, 16 weeks, 2 month Follow Up)

Study Sites (1)

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