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
- 主要终点
- Clinician Affective Reactivity Index (CL-ARI)
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
- 观察性
- 观察模型
- 其他
- 时间视角
- 前瞻性
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)
- 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.
- 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).
- 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
- FOR YOUTH:
- 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:
- 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).
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)
结局指标
主要结局
Clinician Affective Reactivity Index (CL-ARI)
时间窗: Bi-weekly and f/u
A 12-item clinician-administered measure of temper outbursts, irritable mood, and impairment over the past week, based on parent and child report.
Clinical Global Impressions Improvement (CGI-I)
时间窗: Relative to pre-treatment anchor and pre, mid, post and f/u
A clinician-rated, diagnosis-independent measure of overall treatment response, assessing change from relative to a baseline on a 7-point scale (1 = very much improved to 7 = very much worse)
CBT for Irritability-Adherence Scale
时间窗: Post each psychotherapy session
The CBT for irritability- Adherence Scale was developed specifically for the exposure-based CBT treatment we developed. The measure contains 26 items focused on standard elements of cognitive behavioral therapy (e.g., setting agenda, homework, motivation), treatment-specific elements (e.g., exposure for the child and parent skills training for the parent), and mode of delivery elements (e.g., modeling, rehearsal, coaching). Each item is phrased as to the extent to which the therapist adheres to that task; for instance, Therapist encourages child participation in one or more exposure tasks. Therapist completes each measure for child and parent after each of the 12 sessions and rating each item on a 7-point scale: 1 = not at all, 4 = considerably, 7 = extensively.
Working Alliance Inventory (WAI)
时间窗: Post each psychotherapy session
The WAI (Horvath \& Greenberg, 1989) is 12-item, 7-point Likert-scale measure of alliance in the therapist-client dyad. We plan to use this measure to assess the alliance between therapist and parent. Individual item responses range from 0 ( Never ) to 6 ( Always ). Items are worded as statements on the dyadic relationship between therapist and parent. The WAI contains 3 subscales based on Bordin s (1979) analysis of the primary components of therapeutic alliance: Goal, Task, and Bond, which assess the degree to which the parent feels they agree with the therapist on the primary goals of therapy, the usefulness of the tasks completed in therapy, and feelings of trust and compatibility with the therapist, respectively. The WAI has demonstrated good reliability and validity in previous studies (Hatcher et al., 2020; Munder et al., 2010). This measure takes about 5 minutes to complete and will be administered at each session.
Therapeutic Alliance Scale for Children-revised (TASC-r)
时间窗: Post each psychotherapy session
The TASC-R (Shirk \& Saiz, 1992) is a 12-item measure of therapeutic alliance, as reported by the child. The TASC-r contains 2 subscales based on Bordin s (1979) therapeutic alliance research: Bond, or the degree to which the child feels a bond with the therapist, and Task, the child s assessment of whether therapy is a productive and collaborative endeavor (Bordin, 1979). The TASC-r scores have demonstrated good reliability and validity in previous studies (Creed \& Kendall, 2005; DeVet et al., 2003). This measure takes about 5 minutes to complete and will be administered at each session.
次要结局
- Affective Reactivity Index (ARI)(Weekly)
- Brief Irritability Test (BITe)(Pre, mid, post)
- Pediatric Anxiety Rating Scale (PARS)(Pre, mid, post, and f/u)
- Screen for Child Anxiety Related Emotional Disorders (SCARED)(Pre, mid, post)
- ADHD Rating Scale (ADHD-RS)(Pre, mid, post, and f/u)
- Conners Parent Rating Scale Revised (CPRS-R)(Pre, mid, post)
- Child Depression Rating Scale Revised (CDRS-R)(Pre, mid, post, and f/u)
- Mood and Feelings Questionnaire (MFQ)(Pre, mid, post)
- Children s Global Assessment Scale (CGAS):(Pre, mid, post, and f/u)
- Clinical Global Impressions Severity (CGI-S)(Pre, mid, post, and f/u)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT07640802
- 其他研究编号
- 10002713, 002713-M
日期
- 首次提交
- (3个月前)
- 首次发布
- (3个月前)
- 主要完成日期
- (10年后)
- 研究完成日期
- (11年后)
- 最近核实
- (22天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 是
- 是否有结果
- 否
In compliance with current NIH data-sharing policies, de-identified data from participants who have consented to data sharing will be made available in a public repository.