Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Mental Health (NIMH)
Study ID
NCT07640802
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
8 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Psychotherapy — BEHAVIORAL
    Participants will receive either exposure-based cognitive behavioral therapy, parent management training, or psychoeducation supportive psychotherapy.

Study Details

Background: Irritability is defined as proneness to anger that may impair a person s ability to function. It is the number one reason 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.

Key Dates

Start date
Jun 16, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2036
Completion
Dec 31, 2037

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: Children/Adolescents with severe irritability
    Children/Adolescents with severe irritability
  • Arm: Parents/Caregivers of children/adolescents with severe irritability
    Parents/Caregivers of children/adolescents with severe irritability

Primary Outcome Measure

Clinician Affective Reactivity Index (CL-ARI) [ Time Frame: Bi-weekly and f/u ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
NIH Clinical Center Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

Find similar trials in Bethesda, MD

By condition
ADHD
By specialty
PsychiatryMental healthBehavioral health
By research site
National Institutes of Health Clinical Center· Bethesda, MD

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