Parent-Mediated Intervention Targeting Insistence on Sameness for Autistic Children

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

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.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder; Autism
• Intervention / Treatment: Behavioral: Supportive Parenting for Anxious Childhood Emotions (SPACE) for insistence on sameness (IS)

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kari Berquist, PhD; Phone Number: (650) 724-6026; Email: spacestudy@stanford.edu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford University
      • Contact: Kari Berquist, PhD; Phone Number: (650) 724-6026; Email: spacestudy@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active treatment; Eligible participants that enroll will received 16 week parent based intervention for insistence on sameness	Behavioral: Supportive Parenting for Anxious Childhood Emotions (SPACE) for insistence on sameness (IS); This study will examine the potential effectiveness of a virtually delivered parent-mediated intervention for insistence on sameness behaviors in autism. This includes a 16 week protocol where caregivers meet weekly for one hour with a study therapist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in parent rated Dimensional Assessment of Restricted Behavior (DARB) Scores during treatment.	DARB scores measure restricted and repetitive behaviors with higher scores indicating greater intensity.	Screening, Baseline, Weeks 4, 8, 12, 16 and 2 month follow up
Change from baseline in clinician rated clinical global impressions scale scores during treatment.	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.	Weeks 8, 16 and 2 month follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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, Week 16 and 2 month Follow up
Change in Emotion Regulation Checklist scores during treatment	The Emotion Regulation Checklist (ERC) is a 24-item measure of children's self-regulation completed by a caregiver. Items are rated along a continuum (1=rarely, 4=almost always). Higher scores on the Lability/Negativity sub scale indicate more difficulty managing and coping with emotions, while higher scores on the Emotion Regulation sub scale indicate better ability to self-regulate.	Baseline, 16 week
Change in Daily Living Skills Scale Scores during treatment	Higher scores indicate better ability on the DLSS. [Score Range: 0-53]	Baseline, 16 week, 2 month Follow up
Change in Open Source - Challenging Behavior scores during treatment	Higher levels indicate greater levels of challenging behavior and lower levels indicate improvement.	Baseline, 16 weeks, 2 month Follow Up

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Jennifer Phillips, PhD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: June 17, 2024
• First Submitted That Met QC Criteria: June 17, 2024
• First Posted (Actual): June 24, 2024

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Supportive Parenting for Anxious Childhood emotions (SPACE); Restricted Behavior
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Autistic Disorder
• Other Study ID Numbers: IRB-73366

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No