Optimizing Treatment for Depressed Parents of Children With Emotional and Behavioural Problems (OPTED)
4 августа 2026 г. обновлено: Brendan Andrade, University of Toronto
Optimizing Treatment for Depressed Parents of Children With Emotional and Behavioural Problems (OPTED): A Randomized and Controlled Trial
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.
Обзор исследования
Статус
Рекрутинг
Условия
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Оцененный)
180
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Brendan Andrade, PhD
- Номер телефона: 416-946-5905
- Электронная почта: brendan.andrade@utoronto.ca
Места учебы
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Ontario
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Toronto, Ontario, Канада
- Рекрутинг
- Ontario Institute for Studies in Education (OISE)
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Контакт:
- Madison Moloney
- Номер телефона: 30525 416-535-8501
- Электронная почта: madison.moloney@utoronto.ca
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
Inclusion Criteria:
- 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
Exclusion Criteria:
- Parent shows active suicidal ideation, substance use disorder, or psychosis
- they cannot communicate in English
- child previously diagnosed with autism or an intellectual disability
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: ADAPT Treatment
Participants in the experimental arm will receive the novel Addressing Depression and Positiving Parenting Techniques (ADAPT) treatment.
ADAPT is a targeted treatment adapted by the Co-PI based on the Parenting a Child Who Has Intense Emotions program.
The treatment has modules that help parents build emotion regulation skills, distress tolerance skills, and helpful ways of thinking about their parenting.
The program also contains components of standard behavioural parent training, including strategies to build family structure, routines, and predictable parenting responses to children's behavioral challenges.
Additionally, ADAPT includes elements of Dialectical Behaviour Therapy (DBT), an effective intervention for the treatment of adults and youth with dysregulated emotion and behavior.
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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 tools used in this session help to build a collaborative understanding of unique child and parent needs that may be addressed through ADAPT and leave the parent with the hope that ADAPT can be helpful.
The 9 virtual group treatment sessions that follow include modules to help parents understand the multiple potential contributions to their child's emotional/behavioral challenges, build their own emotion regulation skills, distress tolerance skills, and more helpful ways of thinking.
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Активный компаратор: Incredible Years Parenting Program (IYPP)
Participants randomized to the control arm will receive the Incredible Years Parenting Program (IYPP).
IYPP is a best-practice and widely used treatment for parents of children with EBD.
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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.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Changes in child emotional and behavioral difficulties
Временное ограничение: Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
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Child emotional and behavioural difficulties are assessed using the Behaviour and Feelings Survey (BFS).
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Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Changes in parental depression
Временное ограничение: Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
|
Parental depression is assessed using the Patient Health Questionnaire (PHQ-8).
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Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
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Changes in parental quality of life
Временное ограничение: Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
|
Quality of life is assessed using the World Health Organization Disability Assessment 2.0 (WHODAS).
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Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
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Changes in broad parenting practices
Временное ограничение: Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
|
Parenting practices are assessed using the Multidimensional Assessment of Parenting (MAPS).
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Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
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Changes in parental stress
Временное ограничение: Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
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Parental stress is assessed using the self-reported scores on items of the Stress subscale of the Depression, Anxiety, and Stress Scale (DASS-21).
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Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Changes in parental cognition
Временное ограничение: Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
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Parent cognition is assessed using the Parent Cognition Scale (PCS).
The PCS will be examined as a predictor of initial symptom severity and potential treatment mechanism.
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Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
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Changes in parent emotion regulation
Временное ограничение: Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
|
Parent emotion regulaiton is assessed using the Affect Regulation Checklist (ARC).
The PCS will be examined as a predictor of initial symptom severity and potential treatment mechanism.
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Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
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Changes in real-time parent-reported child emotional and behavioral difficulties
Временное ограничение: Baseline (pre-randomization) and post-treatment (12-weeks post-randomization)
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Real-time parent-reported child emotional and behavioral difficulties will be assessed via ecological momentary assessment (EMA) at pre- and post-treatment, capturing momentary ratings of child symptoms.
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Baseline (pre-randomization) and post-treatment (12-weeks post-randomization)
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Changes in the implementation of parenting skills
Временное ограничение: Baseline (pre-randomization) and post-treatment (12-weeks post-randomization).
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Implementation of parenting skills is assessed using the Parenting Skill Use Diary (PSUD).
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Baseline (pre-randomization) and post-treatment (12-weeks post-randomization).
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Changes in child depressive symptoms
Временное ограничение: Baseline (pre-randomization) and post-treatment (12-weeks post-randomization).
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Child depressive symptoms will be assessed using the child-reported Short Mood and Feelings Questionnaire (SMFQ).
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Baseline (pre-randomization) and post-treatment (12-weeks post-randomization).
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Changes in child irritability
Временное ограничение: Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
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Child irritability will be assessed using the parent-reported Affective Reactivity Index (ARI).
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Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
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Changes in child perceptions of parenting behaviour
Временное ограничение: Baseline (pre-randomization) and post-treatment (12-weeks post-randomization)
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Child perceptions of parenting behaviour will be assessed using the Children's Report of Parenting Behavior Inventory (CRPBI).
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Baseline (pre-randomization) and post-treatment (12-weeks post-randomization)
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Changes in parental competence need satisfaction and frustration
Временное ограничение: Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
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Parental competence need satisfaction and frustration will be assessed using the relevant subscales of the Basic Psychological Need Satisfaction and Frustration Scale (BPNSFS).
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Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
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Changes in child callous-unemotional traits
Временное ограничение: Baseline (pre-randomization), post-treatment (12 weeks post-randomization), and 6-month follow-up
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Child callous-unemotional traits will be assessed using the Inventory of Callous-Unemotional Traits (ICU).
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Baseline (pre-randomization), post-treatment (12 weeks post-randomization), and 6-month follow-up
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Changes in child self-reported emotion-regulation
Временное ограничение: Baseline (pre-randomization) and post-treatment (12 weeks post-randomization)
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Child self-reported emotion-regulation will be assessed using the Children's Emotion Management Scales (CEMS).
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Baseline (pre-randomization) and post-treatment (12 weeks post-randomization)
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Changes in parental self-efficacy
Временное ограничение: Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
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Parental self-efficacy is assessed using the Parenting Sense of Competence Scale (PSOC).
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Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
1 августа 2026 г.
Первичное завершение (Оцененный)
1 августа 2030 г.
Завершение исследования (Оцененный)
1 августа 2030 г.
Даты регистрации исследования
Первый отправленный
8 июня 2026 г.
Впервые представлено, что соответствует критериям контроля качества
4 августа 2026 г.
Первый опубликованный (Действительный)
6 августа 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
6 августа 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
4 августа 2026 г.
Последняя проверка
1 августа 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 50526 (SMART IRB)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана IPD
De-identified study data may be shared with other reseachers upon request at the disrection of the PI.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .