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

Overview

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.

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: 1. 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. 2. 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. 3. In all conditions, examine therapeutic support (measured by child/parent and clinician working alliance inventory measure). 4. 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: 1. 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). 2. 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: 1. 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) 2. Determine if degree of exposure in exposure plus parental psychoeducation supportive psychotherapy condition is associated with level of clinical improvement (Secondary Objective 2). 3. Determine if degree of therapeutic support (measured by child/parent and clinician working alliance inventory measure) is associated with clinical response (Secondary Objective 3). 4. 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).