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

2026년 8월 4일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

180

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 캐나다
    • Ontario
      • Toronto, Ontario, 캐나다
        • 모병
        • Ontario Institute for Studies in Education (OISE)
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
행동: 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.
활성 비교기: 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.
행동: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Changes in child emotional and behavioral difficulties
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Changes in parental depression
기간: 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
기간: 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
기간: 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
기간: 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

기타 결과 측정

결과 측정
측정값 설명
기간
Changes in parental cognition
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Toronto

협력자

Centre for Addiction and Mental Health
Women's College Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 8월 1일

기본 완료 (추정된)

2030년 8월 1일

연구 완료 (추정된)

2030년 8월 1일

연구 등록 날짜

최초 제출

2026년 6월 8일

QC 기준을 충족하는 최초 제출

2026년 8월 4일

처음 게시됨 (실제)

2026년 8월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 4일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 50526 (SMART IRB)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다