Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06472115

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Autism Spectrum Disorder Autism Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94305, United States

Location status: Recruiting

Location contact

Kari Berquist, PhD

CONTACT

[email protected]

(650) 724-6026

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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

  1. Change from Baseline in Parent-Rated Anxiety as captured by the Anxiety Scale for Children with Autism Spectrum Disorder (ASC-ASD).

    Time frame: Baseline, Week 16 and 2 month Follow up

    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]

  2. Change in Emotion Regulation Checklist scores during treatment

    Time frame: Baseline, 16 week

    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.

  3. Change in Daily Living Skills Scale Scores during treatment

    Time frame: Baseline, 16 week, 2 month Follow up

    Higher scores indicate better ability on the DLSS. [Score Range: 0-53]

  4. Change in Open Source - Challenging Behavior scores during treatment

    Time frame: Baseline, 16 weeks, 2 month Follow Up

    Higher levels indicate greater levels of challenging behavior and lower levels indicate improvement.

Study contacts

Contact information is provided by the study sponsor or research team.

Kari Berquist, PhD

CONTACT

[email protected]

(650) 724-6026

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 24, 2024
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.