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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01631851
Other study ID # 0102012121-B
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2011
Est. completion date April 23, 2013

Study information

Verified date November 2023
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date April 23, 2013
Est. primary completion date April 23, 2013
Accepts healthy volunteers No
Gender All
Age group 9 Years to 16 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - medical or psychiatric condition that would require alternative treatment

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Yale Child Study Center New Haven Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Yale University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Erratum In: J Am Acad Child Adolesc Psychiatry. 2010 Jul;49(7):727. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary ABC Irritability Scale Parent rating of irritability and disruptive behavior that has been often used in studies with children with ASD 1 week
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