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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-17
SponsorNational Institute of Mental Health (NIMH)

About this trial

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.

Eligibility criteria

Qualifiers

FOR YOUTH

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

Disqualifiers

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.

IQ < 70

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

Trial design

Treatments tested in this trial

  • Psychotherapy

Treatment groups

300 Participants
are divided into 2 treatment groups