Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Non-Active Psychoeducation Supportive Psychotherapy
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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).
2. In each of two arms (arm 1, exposure plus parental support and parent training plus child support vs. arm 2, child and parent support), examine the degree of therapeutic adherence to exposure and parent management training, as well as support experienced by the child and parent.
Secondary Objective:
- Examine if adherence to learning principles skills (i.e., exposure or parent management training) and/or support (i.e., alliance) are associated with symptom improvement in anxiety, depression, and attention deficit hyperactivity symptoms. In the exposure plus parental psychoeducation supportive psychotherapy condition, determine if the degree of exposure (e.g., number of exposures) is associated with level of clinical improvement.
- Explore if the degree of implementation of concrete learning-based skills (e.g., exposure, active ignore, praise, parental consistency) is associated with the level of clinical response.
- In all conditions, examine therapeutic support (measured by child/parent and clinician working alliance inventory measure).
- Upon completion of the 12 sessions, conduct follow-up clinical assessments within 14 days and 3, 6, and 12 months later to determine stability of clinical improvement.
Exploratory Objective:
1. Use natural language processing to derive features/themes of sessions and determine:
1a. Similarities and differences between two treatment conditions.
1b. If specific learning related themes at specific times in treatment are associated with improvement.
2. Determine if there are specific clinical features of the child (e.g., co-occurring attention deficit hyperactivity disorder, anxiety, demographic characteristics) or the parent that are associated with improvement differentially across two active treatment conditions.
Endpoints:
Primary Endpoint:
- Clinical response measured by parent, child, and clinical irritability metrics (affective reactivity index and clinical severity/improvement metrics) in each treatment condition (Primary Objective 1).
- Association between adherence to manualized procedures (i.e., learning based skills) and alliance (i.e., degree of therapeutic support) with each treatment condition (Primary Objective 2)
Secondary Endpoints:
- Association between adherence to manualized procedures (i.e., learning based skills) and alliance (i.e., degree of therapeutic support) with end of treatment anxiety, depression and attention deficit hyperactivity clinical response (Secondary Objective 1)
- Determine if degree of exposure in exposure plus parental psychoeducation supportive psychotherapy condition is associated with level of clinical improvement (Secondary Objective 2).
- Determine if degree of therapeutic support (measured by child/parent and clinician working alliance inventory measure) is associated with clinical response (Secondary Objective 3).
- Determine stability of clinical assessments 3, 6, and 12 months later (Secondary Objective 4).
Exploratory Endpoint:
1. Using natural language processing to derive features/themes of sessions (Exploratory Endpoint 1).
1a. Examine similarities and differences between two treatment conditions
1b. Determine if specific learning related themes at specific times in treatment are associated with improvement.
2. In the pursuit of precision medicine, examine the clinical features of the child (e.g., co-occurring attention deficit hyperactivity disorder, anxiety, demographic characteristics) and the parent to assess if there is differential improvement across the two active treatment conditions associated with baseline factors (Exploratory Endpoint 2).
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Melissa A Brotman, Ph.D.
- Número de teléfono: (301) 496-8281
- Correo electrónico: irritablekids@mail.nih.gov
Ubicaciones de estudio
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Maryland
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Bethesda, Maryland, Estados Unidos, 20892
- National Institutes of Health Clinical Center
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Contacto:
- NIH Clinical Center Office of Patient Recruitment (OPR)
- Número de teléfono: TTY dial 711 800-411-1222
- Correo electrónico: ccopr@nih.gov
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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
EXCLUSION CRITERIA
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
- 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).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Children/Adolescents with severe irritability
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Participants will receive either exposure-based cognitive behavioral therapy, parent management training, or psychoeducation supportive psychotherapy.
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Parents/Caregivers of children/adolescents with severe irritability
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Participants will receive either exposure-based cognitive behavioral therapy, parent management training, or psychoeducation supportive psychotherapy.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Clinician Affective Reactivity Index (CL-ARI)
Periodo de tiempo: 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.
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Bi-weekly and f/u
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Clinical Global Impressions Improvement (CGI-I)
Periodo de tiempo: 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)
|
Relative to pre-treatment anchor and pre, mid, post and f/u
|
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CBT for Irritability-Adherence Scale
Periodo de tiempo: 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.
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Post each psychotherapy session
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Working Alliance Inventory (WAI)
Periodo de tiempo: Post each psychotherapy session
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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.
|
Post each psychotherapy session
|
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Therapeutic Alliance Scale for Children-revised (TASC-r)
Periodo de tiempo: 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.
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Post each psychotherapy session
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Affective Reactivity Index (ARI)
Periodo de tiempo: Weekly
|
A brief parent- and self-report measure of irritability with 6 core items (score range 0 12) and an additional impairment item not included in the total.
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Weekly
|
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Brief Irritability Test (BITe)
Periodo de tiempo: Pre, mid, post
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A 5-item self-report measure assessing irritability over the past two weeks on a 6-point scale, designed to minimize overlap with related constructs.
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Pre, mid, post
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Pediatric Anxiety Rating Scale (PARS)
Periodo de tiempo: Pre, mid, post, and f/u
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A clinician-administered measure of past-week anxiety severity across major domains, using a symptom checklist and severity ratings based on child and parent report.
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Pre, mid, post, and f/u
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Screen for Child Anxiety Related Emotional Disorders (SCARED)
Periodo de tiempo: Pre, mid, post
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A 41-item parent- and child-report measure of recent anxiety symptoms rated on a 3-point scale, with total and subscale scores.
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Pre, mid, post
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ADHD Rating Scale (ADHD-RS)
Periodo de tiempo: Pre, mid, post, and f/u
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A parent-reported, clinician-administered measure of DSM-based ADHD symptoms, with inattention and hyperactivity impulsivity subscales and a total score.
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Pre, mid, post, and f/u
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Conners Parent Rating Scale Revised (CPRS-R)
Periodo de tiempo: Pre, mid, post
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A 28-item parent-report measure of child behavior problems (e.g., oppositionality, hyperactivity, cognitive and anxious traits), rated on a 4-point frequency scale
|
Pre, mid, post
|
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Child Depression Rating Scale Revised (CDRS-R)
Periodo de tiempo: Pre, mid, post, and f/u
|
A 17-item clinician-rated measure of depressive symptom severity in youth, based on child and parent report, with higher scores indicating greater severity.
|
Pre, mid, post, and f/u
|
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Mood and Feelings Questionnaire (MFQ)
Periodo de tiempo: Pre, mid, post
|
A 13-item parent- and child-report measure of depressive symptoms over the past 2 weeks, rated on a 3-point scale; scores (Bullet)29 indicate clinically significant depression.
|
Pre, mid, post
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Children s Global Assessment Scale (CGAS):
Periodo de tiempo: Pre, mid, post, and f/u
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A clinician-rated measure of overall functioning in youth, scored from 1 100, with higher scores indicating better functioning.
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Pre, mid, post, and f/u
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Clinical Global Impressions Severity (CGI-S)
Periodo de tiempo: Pre, mid, post, and f/u
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A clinician-rated, diagnosis-independent measure of current illness severity, scored on a 7-point scale from 1 (not ill) to 7 (extremely ill).
|
Pre, mid, post, and f/u
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Melissa A Brotman, Ph.D., National Institute of Mental Health (NIMH)
Publicaciones y enlaces útiles
Enlaces Útiles
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Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
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Términos relacionados con este estudio
Palabras clave
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Otros números de identificación del estudio
- 10002713
- 002713-M
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
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Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- CIF
- CÓDIGO_ANALÍTICO
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