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OpenTrials
Completed

NCT Number: NCT01882153

Evaluating Parent Delivered Interventions for Children With Autism

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.

Completed

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Key information

Age range

18 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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).

Primary outcomes

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

    Time frame: Difference from Baseline to Week 12

  2. Change in SRS (Social Responsiveness Scale)

    Time frame: Difference from Baseline to Week 12

  3. Change in CDI (Communicative Development Survey) Score

    Time frame: Difference from Baseline to Week 12

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

    Time frame: Difference from Baseline to Week 12

Secondary outcomes

  1. Change in VABS (Vineland Adaptive Behavior Scale) Score

    Time frame: Difference from Baseline to Week 12

  2. Change in social and communication behaviors as assessed from home videos

    Time frame: Difference from Baseline to Week 12

  3. Change in PSI (Parenting Stress Index) Score

    Time frame: Difference from Baseline to Week 12

  4. Change in FES (Family Empowerment Scale) Score

    Time frame: Difference from Baseline to Week 12

  5. Change in frequency and duration of investigation therapy

    Time frame: Difference from Baseline to Week 12

  6. Change in demographics data

    Time frame: Difference from Baseline to Week 12

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2010
Primary completion
2022
Study completion
2022
First posted
Jun 20, 2013
Registry last updated
Jul 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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