Behavior Therapy for Irritability in Autism

NCT04654260 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2025-10-20

No results posted yet for this study

Summary

This is a clinical trial of a novel intervention, Behavioral Therapy for Irritability and Aggression (BTIA), for adolescents on the autism spectrum. The main goals of BTIA are to help adolescents develop emotion regulation skills to handle frustration and to strengthen skills for navigating the challenging and diverse experiences associated with the transition to adulthood. The study will test whether BTIA can be helpful to adolescents on the autism spectrum and to their families.

Conditions

  • Autism Spectrum Disorder
  • Irritability
  • Disruptive Behavior
  • Anger
  • Aggression
  • Asperger Syndrome
  • Pervasive Developmental Disorder

Interventions

BEHAVIORAL

Behavioral Therapy for Irritability in Autism

The child-focused components of BTIA are organized in modules dedicated to emotion regulation, problem solving and practice of planned steps to prevent or resolve conflicts. Each session contains a set of six to seven goals, and each goal contains a menu of techniques and activities that can be used to attain this goal. In order to administer the treatment in a flexible yet reliable manner, the therapist works collaboratively with the child and his or her parents to select activities that are perceived as relevant for attaining the session's goal. The parent-focused components of BTIA include include education about the effects of antecedents and consequences on disruptive behavior, developing strategies for reducing or altering antecedent events that may lead to disruptive reactions and helping parents to use reinforcement of competent and calm responses in potentially frustrating situations.

BEHAVIORAL

Psychoeducation and Supportive Therapy (PST)

Each PST session will start with a review of events of the past week and include queries of topics such as school, interests, hobbies, and family with an overarching goal of enhancing subjective well-being. A major objective is to enables the participant to discuss his or her concerns with a therapist toward a goal of enhancing overall psychological wellbeing. Education about autism diagnosis and services is also provided to families as part of PST.

Sponsors & Collaborators

  • Congressionally Directed Medical Research Programs

    collaborator FED
  • Yale University

    lead OTHER

Principal Investigators

  • Denis Sukhodolsky, Ph.D. · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-10
Primary Completion
2026-02-28
Completion
2026-02-28

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04654260 on ClinicalTrials.gov