Evaluating Parent Delivered Interventions for Children With Autism

Not Applicable

Completed

• Conditions: Autistic Disorder; Developmental Disabilities
• Interventions: Behavioral: Pivotal Response Training (PRT); Behavioral: PACE Therapy; Behavioral: PACE and PRT Hybrid

• Registration Number: NCT01882153
• Lead Sponsor: Stanford University

Brief Summary

The investigators will assess the efficacy of parent delivered interventions in the treatment of social and communication deficits in children with autism. By collecting information about parent and child functioning before and after intervention, the investigators will be able to determine whether the intervention is effective in improving child social communication and reducing parent stress.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2013-06-17
• Study First Submitted QC: 2013-06-19
• Study First Posted: 2013-06-20
• Primary Completion: 2022-02-18
• Study Completion: 2022-02-18
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-13
• Last Update Posted: 2023-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Developmentally Based Intervention	PACE and PRT Hybrid	-
Behaviorally Based Intervention	Pivotal Response Training (PRT)	-
Behaviorally Based Intervention	PACE and PRT Hybrid	-
Developmentally Based Intervention	PACE Therapy	-

Primary Outcome Measures

Name	Time	Method
Change in CGI-S (Clinical Global Impression - Severity)	Difference from Baseline to Week 12
Change in SRS (Social Responsiveness Scale)	Difference from Baseline to Week 12
Change in CDI (Communicative Development Survey) Score	Difference from Baseline to Week 12
Change in social and communication behaviors as assessed by standardized laboratory observations	Difference from Baseline to Week 12

Secondary Outcome Measures

Name	Time	Method
Change in FES (Family Empowerment Scale) Score	Difference from Baseline to Week 12
Change in VABS (Vineland Adaptive Behavior Scale) Score	Difference from Baseline to Week 12
Change in social and communication behaviors as assessed from home videos	Difference from Baseline to Week 12
Change in PSI (Parenting Stress Index) Score	Difference from Baseline to Week 12
Change in frequency and duration of investigation therapy	Difference from Baseline to Week 12
Change in demographics data	Difference from Baseline to Week 12

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States