NCT02028247

Brief Summary

Anxiety disorders affect 40 to 50% of children with autism spectrum disorders (ASD), contributing to substantial distress and impairment. The goal of this study is to examine the effectiveness of a personalized type of psychotherapy against standard-care psychotherapy for addressing anxiety in youth with ASD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
214

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

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

First Submitted

Initial submission to the registry

January 2, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 7, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

November 11, 2021

Completed
Last Updated

November 15, 2021

Status Verified

November 1, 2021

Enrollment Period

3.8 years

First QC Date

January 2, 2014

Results QC Date

October 1, 2019

Last Update Submit

November 10, 2021

Conditions

Autism Spectrum DisordersAutismAsperger's SyndromePervasive Developmental Disability - Not Otherwise SpecifiedObsessive-compulsive DisorderSocial PhobiaGeneralized Anxiety DisorderSpecific PhobiaSeparation Anxiety Disorder

Keywords

Autism spectrum disordersAutismAsperger's syndromePervasive developmental disability - not otherwise specifiedobsessive-compulsive disorderSocial phobiaGeneralized anxiety disorderSpecific phobiaSeparation anxiety disorderCounselingCognitive-behavioral therapyPsychotherapy

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Anxiety Severity on the Pediatric Anxiety Rating Scale After 16 Weeks of Treatment.

    This measure is administered by a clinician and assesses anxiety symptom severity on a scale from 0-25 with higher scores corresponding to worse anxiety.

    Baseline and After 16 Weeks of Treatment

Secondary Outcomes (3)

  • Percentage of Participants With Positive Treatment Response as Assessed by the Clinical Global Impressions-Improvement Scale

    After 16 weeks of treatment

  • Change From Baseline in Anxiety/Depression Severity on the Child Behavior Checklist After 16 Weeks of Treatment.

    Baseline and After 16 weeks of treatment

  • Change From Baseline in Anxiety Related Impairment as Measured by the Childhood Anxiety Impact Scale After 16 Weeks of Treatment.

    Baseline and After 16 weeks of treatment

Study Arms (3)

Personalized Cognitive-behavioral therapy

EXPERIMENTAL

Personalized Cognitive-behavioral therapy involves 16 weekly individual therapy sessions, up to 90 minutes each, based on a treatment protocol that has been designed specifically for youth with high-functioning autism spectrum disorders.

Behavioral: Personalized Cognitive-behavioral therapy

Standard Practice Cognitive-behavioral therapy

ACTIVE COMPARATOR

Standard Practice Cognitive-behavioral therapy involves 16 weekly individual therapy sessions, up to 60 minutes each, based on a treatment protocol that represent the standard practice psychotherapy for anxiety that has been found to be effective in multiple trials in youngsters without autism spectrum disorders.

Behavioral: Standard Practice Cognitive-behavioral therapy

Treatment as Usual

OTHER

Participants randomized to the TAU condition will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions) for a 16-week period. Treatment changes (e.g., medication increase, starting psychotherapy in community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.

Behavioral: Treatment as Usual

Interventions

Personalized Cognitive-behavioral therapyBEHAVIORAL
Also known as: Behavioral Interventions for Anxiety in Children with Autism
Personalized Cognitive-behavioral therapy
Standard Practice Cognitive-behavioral therapyBEHAVIORAL
Also known as: Coping Cat
Standard Practice Cognitive-behavioral therapy
Treatment as UsualBEHAVIORAL
Treatment as Usual

Eligibility Criteria

Age7 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Outpatient boys and girls with ASD between the ages 7-13 years at consent/assent.
  • The child meets criteria for ASD.
  • The child meets criteria for clinically significant anxiety symptoms.
  • The child has a Full Scale and Verbal Comprehension Intelligence Quotient \>70 as assessed on the Wechsler Intelligence Scale for Children-IV or another acceptable Intelligence Quotient test.

You may not qualify if:

  • Receiving concurrent therapy targeting anxiety, social skills training with homework, or behavioral interventions (e.g., applied behavior analysis). This excludes academic tutoring, occupational therapy, speech therapy, school counseling that is no more than 60 minutes per week in duration, school aides, and social skills training groups that do not include homework and are no more than 60 minutes/week in duration.
  • (a) Current clinically significant suicidality or (b) individuals who have engaged in suicidal behaviors within 6 months will be excluded and referred for appropriate clinical intervention.
  • Child has been nonresponsive to an adequate trial of CBT for anxiety within the previous 2 years.
  • Lifetime bipolar disorder, schizophrenia or schizoaffective disorder.
  • Initiation of an antidepressant medication within 12 weeks before study enrollment or an antipsychotic medication 6 weeks before study enrollment or the child has changed the dose of an established medication within 8 weeks before study enrollment (4 weeks for antipsychotic) or during psychotherapy (unless the dose is lowered because of side effects).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rothman Center for Neuropsychiatry, University of South Florida

St. Petersburg, Florida, 33701, United States

Location

Related Publications (3)

  • Wood JJ, Rosenau KA, Muscatello V, Cooper K, Wood KS, Kendall PC, Storch EA. Cognitive Behavioral Therapy for Autistic School-Aged Children with Interfering Anxiety: Impact on Caregiver-Defined Goals. J Autism Dev Disord. 2025 May 8. doi: 10.1007/s10803-025-06852-6. Online ahead of print.

    PMID: 40338510DERIVED

  • Storch EA, Wood JJ, Guzick AG, Small BJ, Kerns CM, Ordaz DL, Schneider SC, Kendall PC. Moderators of Response to Personalized and Standard Care Cognitive-Behavioral Therapy for Youth with Autism Spectrum Disorder and Comorbid Anxiety. J Autism Dev Disord. 2022 Feb;52(2):950-958. doi: 10.1007/s10803-021-05000-0. Epub 2021 Apr 7.

    PMID: 33826038DERIVED

  • Wood JJ, Kendall PC, Wood KS, Kerns CM, Seltzer M, Small BJ, Lewin AB, Storch EA. Cognitive Behavioral Treatments for Anxiety in Children With Autism Spectrum Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2020 May 1;77(5):474-483. doi: 10.1001/jamapsychiatry.2019.4160.

    PMID: 31755906DERIVED

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic DisorderAsperger SyndromeObsessive-Compulsive DisorderPhobia, SocialGeneralized Anxiety DisorderPhobia, SpecificAnxiety, Separation

Interventions

Behavior TherapyTherapeutics

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersAnxiety DisordersPhobic Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Dr. Eric Storch
Organization
Baylor College of Medicine
eric.storch@bcm.edu
7137983579

Study Officials

  • Eric A Storch, Ph.D.

    University of South Florida

    PRINCIPAL INVESTIGATOR

  • Jeff Wood, Ph.D.

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

  • Philip C Kendall, Ph.D.

    Temple University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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
McIngvale Presidential Endowed Chair & Professor

Study Record Dates

First Submitted

January 2, 2014

First Posted

January 7, 2014

Study Start

April 1, 2014

Primary Completion

January 1, 2018

Study Completion

October 1, 2018

Last Updated

November 15, 2021

Results First Posted

November 11, 2021

Record last verified: 2021-11

Locations

US(1)