Parent-Mediated Intervention Targeting Insistence on Sameness for Autistic Children

NCT06472115 | Recruiting

• 1 other identifier: IRB-73366
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder; Autism

Keywords

Supportive Parenting for Anxious Childhood emotions (SPACE); Restricted Behavior

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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 Arms (1)

Active treatment

EXPERIMENTAL

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)

Interventions

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

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.

Active treatment

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• :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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Jennifer Phillips, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kari Berquist, PhD

CONTACT

(650) 724-6026; spacestudy@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 24, 2024
• Study Start: January 5, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

US (1)