Parent-Mediated Intervention Targeting Insistence on Sameness for Autistic Children

Not Applicable

Recruiting

• Conditions: Autism Spectrum Disorder; Autism
• Interventions: Behavioral: Supportive Parenting for Anxious Childhood Emotions (SPACE) for insistence on sameness (IS)

• Registration Number: NCT06472115
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-17
• Study First Submitted QC: 2024-06-17
• Study First Posted: 2024-06-24
• Study Start: 2025-01-05
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-25
• Primary Completion: 2027-10-01
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active treatment	Supportive Parenting for Anxious Childhood Emotions (SPACE) for insistence on sameness (IS)	Eligible participants that enroll will received 16 week parent based intervention for insistence on sameness

Primary Outcome Measures

Name	Time	Method
Change from baseline in parent rated Dimensional Assessment of Restricted Behavior (DARB) Scores during treatment.	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.
Change from baseline in clinician rated clinical global impressions scale scores during treatment.	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 Outcome Measures

Name	Time	Method
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	ASC-ASD captures anxiety with higher scores indicating greater anxiety severity across the subdomains of separation anxiety, uncertainty, performance anxiety, and anxious arousal. \[Score Range: 0-72\]
Change in Emotion Regulation Checklist scores during treatment	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.
Change in Daily Living Skills Scale Scores during treatment	Baseline, 16 week, 2 month Follow up	Higher scores indicate better ability on the DLSS. \[Score Range: 0-53\]
Change in Open Source - Challenging Behavior scores during treatment	Baseline, 16 weeks, 2 month Follow Up	Higher levels indicate greater levels of challenging behavior and lower levels indicate improvement.

Trial Locations

Locations (1)

Jennifer Phillips; 🇺🇸 Stanford, California, United States