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Evaluating Parent Delivered Interventions for Children With Autism

Primary Purpose

Autistic Disorder, Developmental Disabilities

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Pivotal Response Training (PRT)

PACE Therapy

PACE and PRT Hybrid

About this trial

This is an interventional treatment trial for Autistic Disorder

Eligibility Criteria

18 Months - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria for autism participants:

Children between the ages of 1.6 and 17.11 years of age
Males and females
Diagnosis of autism based on DSM-IV-TR criteria, an expert clinical evaluation, and ADOS or ADI-R if needed
Receiving or will receive a parent delivered intervention to alleviate symptoms related to their diagnosis of autistic disorder
Have a care provider that will reliably bring subjects to their chosen intervention and clinic visits, and is trustworthy to provide accurate accounts of services provided to the subject

Inclusion Criteria for developmentally delayed participants:

Will have an age range between 1.6 and 17.11 years of age
Males or females
Diagnosis of a developmental delay or disorder based on DSM-IV-TR, ICD-10, and an expert clinical evaluation
Have historical evidence of significant abnormal developmental milestones as determined by neurological history
Receiving or will receive a parent delivered intervention
Have a care provider that will reliably bring subjects to their chosen intervention and clinic visits, and is trustworthy to provide accurate accounts of services provided to the subject

Exclusion Criteria for autism participants:

Is medically unstable (e.g., more than one seizure a month)
Have a medical diagnosis that causes autism like symptomology (e.g., Fragile X, Down syndrome, Angelman's syndrome, tuberous sclerosis, Rett's disorder)

Exclusion Criteria for developmentally delayed subjects:

Is medically unstable (e.g., more than one seizure a month)
Has a diagnosis of ASD

Sites / Locations

Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Developmentally Based Intervention

Behaviorally Based Intervention

Arm Description

Outcomes

Primary Outcome Measures

Change in CGI-S (Clinical Global Impression - Severity)

Change in SRS (Social Responsiveness Scale)

Change in CDI (Communicative Development Survey) Score

Change in social and communication behaviors as assessed by standardized laboratory observations

Secondary Outcome Measures

Change in VABS (Vineland Adaptive Behavior Scale) Score

Change in social and communication behaviors as assessed from home videos

Change in PSI (Parenting Stress Index) Score

Change in FES (Family Empowerment Scale) Score

Change in frequency and duration of investigation therapy

Change in demographics data

Full Information

NCT ID

NCT01882153

First Posted

June 17, 2013

Last Updated

July 13, 2023

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT01882153

Brief Title

Evaluating Parent Delivered Interventions for Children With Autism

Official Title

Evaluating Parent Delivered Interventions for Children With Autism

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

February 2010 (Actual)

Primary Completion Date

February 18, 2022 (Actual)

Study Completion Date

February 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autistic Disorder, Developmental Disabilities

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

104 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Developmentally Based Intervention

Arm Type

Experimental

Arm Title

Behaviorally Based Intervention

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

Pivotal Response Training (PRT)

Intervention Description

The behaviorally-based intervention is a treatment model that uses the principles of Applied Behavior Analysis (Koegel, Openden, Fredeen, & Koegel, 2006) to increase children's adaptive behaviors and decrease maladaptive behaviors.

Intervention Type

Behavioral

Intervention Name(s)

PACE Therapy

Intervention Description

The developmentally based intervention is grounded in a development theory, that focuses on child-directed interactions with warm and caring individuals that aid in acquiring missed developmental and functional milestones.

Intervention Type

Behavioral

Intervention Name(s)

PACE and PRT Hybrid

Intervention Description

The hybrid based treatment has an eclectic approach that incorporates both systematic (behaviorally-based) and affect-based learning (developmentally-based)that focuses on increasing children's skill development (http://www.pacificautism.org).

Primary Outcome Measure Information:

Title

Change in CGI-S (Clinical Global Impression - Severity)

Time Frame