NCT01631851

Brief Summary

In addition to the core symptoms, children and adolescents with Autism Spectrum Disorder (ASD) often exhibit disruptive behavior problems including irritability, tantrums, noncompliance, and aggression. This is a pilot study of Cognitive-Behavioral Therapy, also known as Anger Control Training, in adolescents with high-functioning ASD. CBT teaches children to recognize antecedents and consequences of problem behavior and to use emotion regulation and problem-solving skills to reduce irritability, aggression and noncompliance. This form of CBT has been well-studied in typically developing children with disruptive behavior and we are investigating if this treatment can be feasible and helpful, with appropriate modifications, for irritability and disruptive behavior in ASD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2011

Typical duration 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

May 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 29, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2013

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

2 years

First QC Date

June 27, 2012

Last Update Submit

November 15, 2023

Conditions

AutismAutism Spectrum Disorder (ASDAsperger's DisorderPervasive Developmental Disorder (PDD-NOS)

Keywords

AutismIrritabilityDisruptive BehaviorAggressionBehavior TherapyCognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

  • ABC Irritability Scale

    Parent rating of irritability and disruptive behavior that has been often used in studies with children with ASD

    1 week

Study Arms (1)

Cognitive behavior therapy

EXPERIMENTAL
Behavioral: Cognitive-Behavioral Therapy (CBT) for Irritability

Interventions

Cognitive-Behavioral Therapy (CBT) for IrritabilityBEHAVIORAL

CBT is an individually administered behavioral interventions aimed at reducing irritability and disruptive behavior. There are 10 to 12 weekly sessions that are conducted with the child and the parent. During these sessions children are taught to recognize antecedents and consequences of problem behavior and to use emotion regulation and problem-solving skills to reduce irritability, aggression and noncompliance.

Also known as: Anger Control Training
Cognitive behavior therapy

Eligibility Criteria

Age9 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • DSM-IV diagnosis of autistic disorder, Asperger's disorder, or PDD-NOS
  • presence of disruptive behaviors such as irritability and anger outbursts
  • IQ above 80
  • Unmedicated or on stable medication

You may not qualify if:

  • medical or psychiatric condition that would require alternative treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale Child Study Center

New Haven, Connecticut, 06520, United States

Location

Related Publications (2)

  • Sukhodolsky DG, Vitulano LA, Carroll DH, McGuire J, Leckman JF, Scahill L. Randomized trial of anger control training for adolescents with Tourette's syndrome and disruptive behavior. J Am Acad Child Adolesc Psychiatry. 2009 Apr;48(4):413-421. doi: 10.1097/CHI.0b013e3181985050.

    PMID: 19242384BACKGROUND

  • Aman MG, McDougle CJ, Scahill L, Handen B, Arnold LE, Johnson C, Stigler KA, Bearss K, Butter E, Swiezy NB, Sukhodolsky DD, Ramadan Y, Pozdol SL, Nikolov R, Lecavalier L, Kohn AE, Koenig K, Hollway JA, Korzekwa P, Gavaletz A, Mulick JA, Hall KL, Dziura J, Ritz L, Trollinger S, Yu S, Vitiello B, Wagner A; Research Units on Pediatric Psychopharmacology Autism Network. Medication and parent training in children with pervasive developmental disorders and serious behavior problems: results from a randomized clinical trial. J Am Acad Child Adolesc Psychiatry. 2009 Dec;48(12):1143-54. doi: 10.1097/CHI.0b013e3181bfd669.

    PMID: 19858761BACKGROUND

MeSH Terms

Conditions

Autistic DisorderAutism Spectrum DisorderAsperger SyndromeChild Development Disorders, PervasiveProblem BehaviorAggression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental DisordersBehavioral SymptomsBehaviorChild BehaviorAberrant Motor Behavior in DementiaSocial Behavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Denis Sukhodolsky, Ph.D.

    Yale University, Child Study Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2012

First Posted

June 29, 2012

Study Start

May 1, 2011

Primary Completion

April 23, 2013

Study Completion

April 23, 2013

Last Updated

November 18, 2023

Record last verified: 2023-11

Locations

US(1)