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Идёт набор NCT07749521

Optimizing Treatment for Depressed Parents of Children With Emotional and Behavioural Problems

Без фазы С лечением Depression / Major Depressive Disorder Conduct Disorders in Children Disruptive Behaviour in Children Parenting Intervention

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: ADAPT Treatment, Incredible Years Parenting Program (IYPP).
Кому может быть актуально
Состояния в реестре: Depression / Major Depressive Disorder, Conduct Disorders in Children, Disruptive Behaviour in Children, Parenting Intervention. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
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Официальное название

Optimizing Treatment for Depressed Parents of Children With Emotional and Behavioural Problems (OPTED): A Randomized and Controlled Trial

Обзор

Standard Behavioral Parent Training (BPT) is often less effective for parents experiencing depression. As such, the Addressing Depression and Positive Parenting Techniques (ADAPT) intervention is a novel BPT tailored to address the unique emotional and cognitive needs of depressed parents to improve treatment outcomes. The objective of this study is to determine the efficacy of ADAPT in reducing child emotional and behavioral difficulties compared to the gold-standard Incredible Years Parenting Program (IYPP). This study is a 4-year, individually-randomized group treatment (IRGT), parallel-group trial. We aim to recruit 180 caregivers and their children (aged 6-11 years) seeking treatment for their child's emotional and behavioral difficulties from multiple mental health centres across Toronto, including but not limited to the University of Toronto, Centre for Addiction and Mental Health (CAMH), and Women's College Hospital (WCH). Participants will be asked to complete research measures: * before randomization * post-treatment * 6 months after the end of treatment Participants will be randomized to either the experimental ADAPT intervention - A 10-session virtual program (1 individual, 9 group) focused on emotion regulation, distress tolerance, and cognitive restructuring, or the control intervention: Incredible Years Parent Program (IYPP) - A 12-session gold-standard BPT delivered virtually.

Вмешательства

  • Поведенческое ADAPT Treatment
    ADAPT is a 10-session virtual caregiver program (one individual engagement session and nine group sessions) that was developed with clinician and parent input. The initial engagement session is an individual meeting between the group facilitator and parent to build rapport and learn about the parent's unique challenges and parenting needs. Based on a motivational interviewing framework, this session is designed to gather information, discuss readiness for treatment and goals. The questions and t
  • Поведенческое Incredible Years Parenting Program (IYPP)
    The 12-session manualized treatment is considered a gold-standard treatment because it has shown efficacy in large-scale randomized and controlled trials and meta-analyses. Parents are helped to shift their children's emotional and behavioral difficulties through improved parental skills and competencies with behaviour management, and a parental problem-solving approach. IYPP will be delivered virtually.

Первичные конечные точки

  • Changes in child emotional and behavioral difficulties [Срок оценки: Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up]
Вторичные конечные точки (4)
  • Changes in parental depression [Срок оценки: Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up]
  • Changes in parental quality of life [Срок оценки: Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up]
  • Changes in broad parenting practices [Срок оценки: Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up]
  • Changes in parental stress [Срок оценки: Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up]

Критерии участия

Критерии включения

  • 18 years of age or above
  • has a child aged 6-11 years with clinically elevated emotional and behavioural disorders (Abnormal Range, 93rd percentile) on the Total Difficulties Scale of the Strength and Difficulties Questionnaire (SDQ)
  • parent shows clinical elevations for mild-moderate depression on the Patient Health Questionnaire-8 (PHQ-8) (>4 and <15)
  • capacity to tolerate a virtual group context assessed by clinical interview

Критерии исключения

  • Parent shows active suicidal ideation, substance use disorder, or psychosis
  • they cannot communicate in English
  • child previously diagnosed with autism or an intellectual disability

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Канада · 1 центр
  • Ontario Institute for Studies in Education (OISE) — Toronto

Идентификаторы

NCT: NCT07749521 · 50526

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗