Parent-Mediated Intervention Targeting Insistence on Sameness for Autistic Children

Stanford University30 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Autism Spectrum Disorder Autism

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.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 11 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Stanford University

Stanford, California, United States

RECRUITING

Outcomes

Primary Outcomes

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.

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.

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.

Time frame: Weeks 8, 16 and 2 month follow up

Secondary Outcomes

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

ASC-ASD captures anxiety with higher scores indicating greater anxiety severity across the subdomains of separation anxiety, uncertainty, performance anxiety, and anxious arousal. \[Score Range: 0-72\]

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

Change in Emotion Regulation Checklist scores during treatment

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.

Time frame: Baseline, 16 week

Change in Daily Living Skills Scale Scores during treatment

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

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

Central Contacts

Kari Berquist, PhD

CONTACT

(650) 724-6026 spacestudy@stanford.edu

Data from ClinicalTrials.gov

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