CompletedNot Applicable

Behavior Therapy for Irritability in Autism

United States65 participantsStarted 2020-12-10

Plain-language 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.

Who can participate

Age range

12 Years – 19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Boys and girls, ages 12 to 18 years inclusive * Diagnosis of autism spectrum disorder * Presence of disruptive behaviors such as irritability and anger outbursts * No planned changes in the intensity of current treatment(s) * Medication free or on stable medication * Sufficient language for participation in verbal therapy * Lives within driving distance from New Haven, CT Exclusion Criteria: * Presence of a medical condition that would interfere with participation in the study * Presence of a current psychiatric disorder that requires immediate clinical attention

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Modified Overt Aggression Scale (MOAS)

Timeframe: baseline (week 0)

Modified Overt Aggression Scale (MOAS)

Timeframe: midpoint (week 8)

Modified Overt Aggression Scale (MOAS)

Timeframe: endpoint (week 16)

Modified Overt Aggression Scale (MOAS)

Timeframe: six-month follow up (week 42)

The Clinical Global Impression - Improvement Score (CGI-I)

Timeframe: baseline (week 0)

The Clinical Global Impression - Improvement Score (CGI-I)

Timeframe: midpoint (week 8)

The Clinical Global Impression - Improvement Score (CGI-I)

Timeframe: endpoint (week 16)

Trial details

NCT IDNCT04654260

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-01

View on ClinicalTrials.gov More Autism Spectrum Disorder trials

Plain-language summary

Who can participate

Age range

12 Years – 19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Modified Overt Aggression Scale (MOAS)

Timeframe: baseline (week 0)

Modified Overt Aggression Scale (MOAS)

Timeframe: midpoint (week 8)

Modified Overt Aggression Scale (MOAS)

Timeframe: endpoint (week 16)

Modified Overt Aggression Scale (MOAS)

Timeframe: six-month follow up (week 42)

The Clinical Global Impression - Improvement Score (CGI-I)

Timeframe: baseline (week 0)

The Clinical Global Impression - Improvement Score (CGI-I)

Timeframe: midpoint (week 8)

The Clinical Global Impression - Improvement Score (CGI-I)

Timeframe: endpoint (week 16)