Psychotherapy for Irritability in Youth: Comparing Active Treatment to Non-Active Psychoeducation Supportive Psychotherapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 410
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
Study Description:
This study will be a randomized psychotherapy study comparing the efficacy of learning-based active treatment teaching children/parent specific skills (either exposure therapy for irritability plus parental psychoeducation supportive psychotherapy or parent management therapy plus child psychoeducation supportive psychotherapy) vs. non active control treatment match on time with a therapist without skill advancement (child- and parent- psychoeducation supportive psychotherapy, typical current standard of care). A prior IRB protocol (15-M-0182) demonstrated efficacy of exposure therapy for irritability with parent management training. Here, we compare the learning-based active treatment (exposure with child or parent management training with parent) to non-active psychoeducation supportive psychotherapy sessions matched on time with a therapist.
Objectives:
Primary Objectives:
1. Compare the efficacy of learning based active treatment (arm 1, exposure therapy for irritability plus parental psychoeducation supportive psychotherapy or parent management therapy plus child psychoeducation supportive psychotherapy) vs. non-active support matched on time with a therapist (arm 2, child psychoeducation supportive psychotherapy plus parent psychoeducation supportive psychotherapy).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA 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.
- •2a. Such events occur, on average, at least three times a week.
- •2b. This irritability is impairing in at least two of three domains (home, school, peers)
- •3. Patients must be fluent in English
- •3a. Participants must be able to speak and read English. This study evaluates English language, manualized psychotherapies. The intervention materials, therapist and rater training and supervision procedures, fidelity ratings, and primary outcome measure are
- •currently available and validated only in English. Because psychotherapy relies on nuanced verbal exchange, use of translation or interpreters could alter treatment content, affect therapeutic alliance, compromise fidelity, and limit accurate clinical risk assessment. Examining fidelity and alliance/support are our primary and secondary objective in this study. Therefore, enrolling non-English speakers can introduce a confound to these research questions. Restricting enrollment to English-speaking participants is therefore necessary to ensure participant safety and scientific validity in this trial. Critically, this eligibility criterion is based solely on the language requirements of the intervention and study procedures and is not intended to exclude participants on the basis of race or ethnicity or any other factors.
- •4. On the basis of record review and interviews with child and parent, the research team agrees that the child s response to his/her current treatment is no more than minimal (i.e. CGI-S of 3 or more).
- •5. Must have no planned changes in outpatient psychiatric treatment regimen, which can include psychotropic medications and/or psychotherapeutic interventions, two weeks prior to enrollment.
- •INCLUSION CRITERIA FOR PARENT:
- •Parent of a child eligible for this protocol that can attend 12 parent sessions
- •Fluent in English
排除标准
- •Participants will be screened to exclude participants who would not be able to engage in psychotherapy.
- •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 as assessed by a WASI or assessment by trained clinical staff
- •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.
- •EXCLUSION CRITERIA FOR PARENTS:
- •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).
研究组 & 干预措施
Children/Adolescents with severe irritability
Children/Adolescents with severe irritability
干预措施: Psychotherapy (Behavioral)
Parents/Caregivers of children/adolescents with severe irritability
Parents/Caregivers of children/adolescents with severe irritability
干预措施: Psychotherapy (Behavioral)