Evaluating Parent Delivered Interventions for Children With Autism

NCT01882153 | Completed

• 1 other identifier: SU-11232011-8727
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• 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 FES (Family Empowerment Scale) Score

  Difference from Baseline to Week 12

• Change in frequency and duration of investigation therapy

  Difference from Baseline to Week 12

Study Arms (2)

Developmentally Based Intervention

EXPERIMENTAL

Behavioral: PACE Therapy; Behavioral: PACE and PRT Hybrid

Behaviorally Based Intervention

EXPERIMENTAL

Behavioral: Pivotal Response Training (PRT); Behavioral: PACE and PRT Hybrid

Interventions

Pivotal Response Training (PRT) 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.

Behaviorally Based Intervention

PACE Therapy 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.

Developmentally Based Intervention

PACE and PRT Hybrid 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; Developmentally Based Intervention

Eligibility Criteria

• Age: 18 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Autistic Disorder; Developmental Disabilities

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Antonio Y Hardan, M.D.

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 17, 2013
• First Posted: June 20, 2013
• Study Start: February 1, 2010
• Primary Completion: February 18, 2022
• Study Completion: February 18, 2022
• Last Updated: July 14, 2023

Record last verified: 2023-07

Locations

US (1)