Parent Management Training to Treat Irritability

Официальное название

The Efficacy of Parent Management Training to Treat Irritability

Обзор

The goal of this clinical trial is to see if 12 sessions of a Parent Management Training program can treat irritability in children aged 10-14 years old. The main question it aims to answer are: * Can a Parent Management Training for parents reduce anger outbursts and cranky moods in their children? * Can Parent Management Training be done in an outpatient clinic and do parents like it? Up to 24 families can join this study. Parent participants will complete 12 sessions of Parent Management Training for Irritability. Each session will be 45-55 minutes weekly. They will also participate in the assessments of their child before, during and after treatment. Child participants will do assessments before, during and after the Parent Management Training treatment.

Подробное описание

Up to 24 families will be consented for this Parent Management Training (PMT) to Treat Irritability study in order to meet the aim of having 12 families complete the study. The child and a parent will complete pre-treatment evaluations about the child's mental health, behavior and cognitive functioning. Participants who meet inclusion criteria (age 10-14 with significant irritability) and do not meet exclusion criteria (e.g. Autism, Bipolar disorder, active PTSD, serious medical issues or Intellectual disability) will be invited to join the trial. All participants will receive the 12 PMT sessions from a licensed mental health professional. The PMT sessions will focus on the parents only, but both the parent and child will complete standardized measures and interview with a clinician in the middle of the treatment. After the 12 sessions of PMT, the parent and child will complete a post-treatment assessment. Pre and post treatments assessments will be compared to determine changes in the child's irritability and other areas of functioning.

Вмешательства

• Поведенческое Parent Management Training
  developing parenting skills and competencies dealing with oppositional and irritable behaviors in the child.

Первичные конечные точки

• Demonstrate the feasibility of Parent Management Training (PMT) procedures [Срок оценки: 5 months]

Вторичные конечные точки (1)

• Change in irritability [Срок оценки: 5 months]

Критерии участия

Критерии включения

• clinically significant irritability (Clinician Affective Reactivity Index 30 or greater)
• parent or guardian with whom the child resides for at least 50% of the time is willing to participate in treatment with the child

Критерии исключения

• psychiatric instability (danger to self/others, risky substance abuse)
• current active Post-Traumatic Stress Disorder (PTSD) or a severe active stressor (e.g. child abuse)
• history of severe psychopathology with an established alternate treatment (e.g. autism spectrum disorder, bipolar disorder, schizophrenia, intellectual disability)
• general medical condition that may be driving irritability or prevent generalizable physiologic measures.
• screen positive for an intellectual disability via Wechsler Abbreviated Scale of Intelligence Second Edition (WASI II) estimated Intelligence Quotient (IQ)<70.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Childrens Hospital Colorado — Aurora

Идентификаторы

NCT: NCT06020261 · 23-0065

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗