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Recruiting NCT06472115

Parent-Mediated Intervention Targeting Insistence on Sameness for Autistic Children

No phase Interventional Autism Spectrum Disorder Autism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Supportive Parenting for Anxious Childhood Emotions (SPACE) for insistence on sameness (IS).
Who it may be relevant to
Registry conditions: Autism Spectrum Disorder, Autism. Basic parameters: 6 years — 11 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (4)
  • 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]
  • Change in Emotion Regulation Checklist scores during treatment [Time frame: Baseline, 16 week]
  • Change in Daily Living Skills Scale Scores during treatment [Time frame: Baseline, 16 week, 2 month Follow up]
  • Change in Open Source - Challenging Behavior scores during treatment [Time frame: Baseline, 16 weeks, 2 month Follow Up]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Stanford University — Stanford

Identifiers

NCT: NCT06472115 · IRB-73366

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗