Recruiting

Observational Study

Sponsor:

Stanford University

Code:

NCT06472115

Conditions

Autism Spectrum Disorder

Autism

Eligibility Criteria

Sex: All

Age: 6 - 11

Healthy Volunteers: Accepted

Interventions

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

Study Details

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

Study ID

NCT06472115

Start date

Jan 5, 2025

Status verified date

Feb, 2026

Completion date

Oct 1, 2027

Anticipated

Primary completion date

Oct 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 11

Healthy Volunteers: Accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active treatment

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

Interventions

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.

Primary outcome measure

  • 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 ]
  • Change from baseline in clinician rated clinical global impressions scale scores during treatment. [ Time Frame: Weeks 8, 16 and 2 month follow up ]

Central Contacts and Locations

Central contacts

Kari Berquist, PhD

(650) 724-6026spacestudy@stanford.edu

Locations

Stanford University

Recruiting

Stanford, California, United States, 94305

Contacts

Kari Berquist, PhD

(650) 724-6026spacestudy@stanford.edu

More Information

Sponsor

Stanford University

Last update posted

Feb 25, 2026

Last verified

Feb, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-02-25.