NCT02010086

Brief Summary

The study is a randomized controlled trial to examine the efficacy of individual cognitive behavioral therapy (CBT) relative to a standard community treatment, in youngsters with autism spectrum disorder (ASD). The individual CBT program has been tailored over the last five years to the clinical needs of high-functioning youth with ASD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 12, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

September 7, 2018

Status Verified

September 1, 2018

Enrollment Period

3.9 years

First QC Date

December 9, 2013

Last Update Submit

September 5, 2018

Conditions

Autism Spectrum Disorder

Keywords

InterventionAutismTreatment sensitivitySchool agedCognitive behavioral therapySocial Skills Intervention

Outcome Measures

Primary Outcomes (1)

  • Playground Observation of Peer Engagement scale

    An independent evaluator-rated school playground observational measure of joint engagement, which is a valid measure of core autism symptoms with established treatment sensitivity

    Post-Treatment (week 32)

Study Arms (2)

Individual Cognitive Behavioral Therapy

EXPERIMENTAL
Behavioral: Individual Cognitive Behavioral Therapy

Standard Community Treatment

ACTIVE COMPARATOR
Behavioral: Standard Community Treatment

Interventions

Individual Cognitive Behavioral TherapyBEHAVIORAL

Therapists will work with families for 32 weekly sessions, each lasting 90 minutes, implementing the CBT manual for children with ASD (Wood et al., 2007).

Individual Cognitive Behavioral Therapy
Standard Community TreatmentBEHAVIORAL

In this condition, the child meets with a therapist for 32 weekly sessions, each 90 minutes. Therapists use an established manual to provide a standard community therapy treatment.

Standard Community Treatment

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Meets research criteria for a diagnosis of autism, based on child scores on the ADI-R and ADOS tests.
  • If taking medication, have maintained a stable dose for 1 month prior to baseline assessment.
  • Between the ages of 6-9 years.
  • The child's teacher consents to participate in the study to play a modest role in helping implement the intervention and facilitate the school observation assessment.

You may not qualify if:

  • IQ less than 85.
  • The child starts taking new medication(s) or current medication dose changes either (a) less than 1 month prior to the diagnostic evaluation, or (b) during the study period.
  • The child is participating in an intensive early intervention program for autism such as applied behavior analysis or floortime.
  • For any reason the child or parents appear unable to participate in the treatment program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jeffrey Wood

Los Angeles, California, 90024, United States

Location

Related Publications (2)

  • Wood JJ, Kuhfeld M, Sturm A, Cai L, Wood KS, Cornejo Guevara MV, Galan CA, Johnson AR, Cho AC, Weisz JR. Personalized autism symptom assessment with the Youth Top Problems Scale: Observational and parent-report formats for clinical trials applications. Psychol Assess. 2022 Jan;34(1):43-57. doi: 10.1037/pas0001065. Epub 2021 Aug 30.

    PMID: 34460285DERIVED

  • Wood JJ, Sze Wood K, Chuen Cho A, Rosenau KA, Cornejo Guevara M, Galan C, Bazzano A, Zeldin AS, Hellemann G. Modular cognitive behavioral therapy for autism-related symptoms in children: A randomized controlled trial. J Consult Clin Psychol. 2021 Feb;89(2):110-125. doi: 10.1037/ccp0000621.

    PMID: 33705167DERIVED

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 9, 2013

First Posted

December 12, 2013

Study Start

December 1, 2011

Primary Completion

November 1, 2015

Study Completion

June 1, 2016

Last Updated

September 7, 2018

Record last verified: 2018-09

Locations

US(1)