Evaluating Parent Delivered Interventions for Children With Autism

NCT ID: NCT01882153

Last Updated: 2023-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2022-02-18

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.

Conditions

Autistic Disorder; Developmental Disabilities

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Developmentally Based Intervention

Group Type: EXPERIMENTAL

PACE Therapy

Intervention Type: BEHAVIORAL

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.

PACE and PRT Hybrid

Intervention Type: BEHAVIORAL

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).

Behaviorally Based Intervention

Group Type: EXPERIMENTAL

Pivotal Response Training (PRT)

Intervention Type: BEHAVIORAL

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.

PACE and PRT Hybrid

Intervention Type: BEHAVIORAL

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).

Interventions

Pivotal Response Training (PRT)

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

PACE Therapy

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

PACE and PRT Hybrid

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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)

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

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Antonio Hardan

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonio Y Hardan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

SU-11232011-8727

Identifier Type: -

Identifier Source: org_study_id