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

2026年8月4日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

180

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • カナダ
    • Ontario
      • Toronto、Ontario、カナダ
        • 募集
        • Ontario Institute for Studies in Education (OISE)
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  1. 18 years of age or above
  2. 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)
  3. parent shows clinical elevations for mild-moderate depression on the Patient Health Questionnaire-8 (PHQ-8) (>4 and <15)
  4. capacity to tolerate a virtual group context assessed by clinical interview

Exclusion Criteria:

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
行動：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 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.
アクティブコンパレータ：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.
行動：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Changes in child emotional and behavioral difficulties
時間枠：Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
Child emotional and behavioural difficulties are assessed using the Behaviour and Feelings Survey (BFS).
Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up

二次結果の測定

結果測定
メジャーの説明
時間枠
Changes in parental depression
時間枠：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).
Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
Changes in parental quality of life
時間枠：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).
Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
Changes in broad parenting practices
時間枠：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).
Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
Changes in parental stress
時間枠：Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
Parental stress is assessed using the self-reported scores on items of the Stress subscale of the Depression, Anxiety, and Stress Scale (DASS-21).
Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up

その他の成果指標

結果測定
メジャーの説明
時間枠
Changes in parental cognition
時間枠：Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
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.
Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
Changes in parent emotion regulation
時間枠：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.
Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
Changes in real-time parent-reported child emotional and behavioral difficulties
時間枠：Baseline (pre-randomization) and post-treatment (12-weeks post-randomization)
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.
Baseline (pre-randomization) and post-treatment (12-weeks post-randomization)
Changes in the implementation of parenting skills
時間枠：Baseline (pre-randomization) and post-treatment (12-weeks post-randomization).
Implementation of parenting skills is assessed using the Parenting Skill Use Diary (PSUD).
Baseline (pre-randomization) and post-treatment (12-weeks post-randomization).
Changes in child depressive symptoms
時間枠：Baseline (pre-randomization) and post-treatment (12-weeks post-randomization).
Child depressive symptoms will be assessed using the child-reported Short Mood and Feelings Questionnaire (SMFQ).
Baseline (pre-randomization) and post-treatment (12-weeks post-randomization).
Changes in child irritability
時間枠：Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
Child irritability will be assessed using the parent-reported Affective Reactivity Index (ARI).
Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
Changes in child perceptions of parenting behaviour
時間枠：Baseline (pre-randomization) and post-treatment (12-weeks post-randomization)
Child perceptions of parenting behaviour will be assessed using the Children's Report of Parenting Behavior Inventory (CRPBI).
Baseline (pre-randomization) and post-treatment (12-weeks post-randomization)
Changes in parental competence need satisfaction and frustration
時間枠：Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
Parental competence need satisfaction and frustration will be assessed using the relevant subscales of the Basic Psychological Need Satisfaction and Frustration Scale (BPNSFS).
Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
Changes in child callous-unemotional traits
時間枠：Baseline (pre-randomization), post-treatment (12 weeks post-randomization), and 6-month follow-up
Child callous-unemotional traits will be assessed using the Inventory of Callous-Unemotional Traits (ICU).
Baseline (pre-randomization), post-treatment (12 weeks post-randomization), and 6-month follow-up
Changes in child self-reported emotion-regulation
時間枠：Baseline (pre-randomization) and post-treatment (12 weeks post-randomization)
Child self-reported emotion-regulation will be assessed using the Children's Emotion Management Scales (CEMS).
Baseline (pre-randomization) and post-treatment (12 weeks post-randomization)
Changes in parental self-efficacy
時間枠：Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
Parental self-efficacy is assessed using the Parenting Sense of Competence Scale (PSOC).
Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University of Toronto

協力者

Centre for Addiction and Mental Health
Women's College Hospital

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年8月1日

一次修了 (推定)

2030年8月1日

研究の完了 (推定)

2030年8月1日

試験登録日

最初に提出

2026年6月8日

QC基準を満たした最初の提出物

2026年8月4日

最初の投稿 (実際)

2026年8月6日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月6日

QC基準を満たした最後の更新が送信されました

2026年8月4日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 50526 (SMART IRB)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

De-identified study data may be shared with other reseachers upon request at the disrection of the PI.

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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