Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation … (NCT07640802) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
United States300 participantsStarted 2026-07-01
Plain-language summary
Background:
Irritability is defined as proneness to anger that may impair a person s ability to function. It is a common reason for why some children need mental health care. Yet no therapies have been developed just to target irritability. Researchers want to compare different types of therapy for irritability.
Objective:
To test different types of therapy for children and teens with severe irritability.
Eligibility:
People aged 8 to 16.5 years with severe irritability. Their parents are also needed.
Design:
Participants will have 28 study visits in 18 months.
They will have a baseline visit. They will answer questions about their mood, behavior, and daily life.
All parents and children will have 12 therapy sessions. Sessions will be once a week; they will last 30 to 60 minutes. Some of the child sessions may be done by telehealth.
Each parent and child will have 1 of 3 therapy types:
Exposure therapy (child). Participants will face things that make them angry. A therapist will help them practice managing their anger.
Management therapy (parent). Therapists will coach parents on ways to manage their child s behaviors.
Psychoeducation/supportive psychotherapy (child and/or parent). Participants will talk with therapists about their or their child s feelings and behaviors. They will list their problems and goals; build coping skills; learn to relax; improve communication; and work on managing stress.
Sessions may be videotaped. Participants may opt out of being recorded.
Participants will have phone calls every 2 weeks during therapy. They will answer questions about how they are doing. Follow-up calls will continue for 1 year after therapy.
Who can participate
Age range
8 Years – 17 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
. Age 8-16.5 years
. Caregiver and/or child reports irritability as a primary clinical concern. Specifically, compared to his/her peers, the child exhibits markedly increased reactivity to negative emotional stimuli that manifests verbally or behaviorally. For example, the child responds to frustration with extended temper tantrums (inappropriate for age and/or precipitating event), verbal rages, and/or aggression toward people or property.
. Parent of a child eligible for this protocol that can attend 12 parent sessions
. Fluent in English
Exclusion criteria
. Active major depressive disorder or history of psychosis, bipolar I disorder, Level 2 or 3 autism spectrum disorder, active severe substance use disorders (within the last month), conduct disorder, have active suicidal intent or plan as detected on screening instruments.
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.
1This trial is comparing an active psychotherapy to something called 'nonactive psychoeducation supportive psychotherapy' — can you explain what my child would actually experience in each group, and how we'd feel about it if they were assigned to the less intensive one?
2Since this trial hasn't started recruiting yet, what are my child's best options right now for managing irritability or DMDD while we wait to see if it opens, and would joining this study later delay any standard treatments they might need sooner?
3The trial seems to be measuring things like therapist-child alliance and how well the therapy is being delivered, not just symptom improvement — does that mean it's more focused on testing whether the therapy works as designed rather than proving it helps kids feel better, and what should I understand about that?
4My child might have ADHD alongside the irritability or ODD — would that affect whether this trial might be a good fit to discuss with you, or could it complicate how their progress is measured?
5Since this is listed as Phase NA, which I think means it may be a behavioral or psychotherapy study rather than a drug trial, can you help me understand what the known risks are for my child participating, and whether there's any concern about withholding a more proven treatment during the study period?
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
1
Clinician Affective Reactivity Index (CL-ARI)
Timeframe: Bi-weekly and f/u
2
Clinical Global Impressions Improvement (CGI-I)
Timeframe: Relative to pre-treatment anchor and pre, mid, post and f/u
3
CBT for Irritability-Adherence Scale
Timeframe: Post each psychotherapy session
4
Working Alliance Inventory (WAI)
Timeframe: Post each psychotherapy session
5
Therapeutic Alliance Scale for Children-revised (TASC-r)
. Past or present medical or neurological condition, disease, disorder, genetic finding, or injury that, in the opinion of the Investigator, may significantly increase the potential risks of study participation, reduce or compromise a subject s ability to fully comply with all study requirements for the duration of the study or may compromise the integrity of the data.
. IQ \< 70
. Have any serious medical, mental health, or any condition that interferes with participation, such as active psychosis.
. Current alcohol or substance use or dependence (excluding nicotine) within the past 3 months of sufficient magnitude to require independent, concurrent treatment intervention (e.g. Antabuse or opiate treatment but not including self-help groups).