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

4 sierpnia 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

180

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Kanada
    • Ontario
      • Toronto, Ontario, Kanada
        • Rekrutacyjny
        • Ontario Institute for Studies in Education (OISE)
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Behawioralne: 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.
Aktywny komparator: 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.
Behawioralne: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Changes in child emotional and behavioral difficulties
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Changes in parental depression
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Changes in parental cognition
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Toronto

Współpracownicy

Centre for Addiction and Mental Health
Women's College Hospital

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 sierpnia 2026

Zakończenie podstawowe (Szacowany)

1 sierpnia 2030

Ukończenie studiów (Szacowany)

1 sierpnia 2030

Daty rejestracji na studia

Pierwszy przesłany

8 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

4 sierpnia 2026

Pierwszy wysłany (Rzeczywisty)

6 sierpnia 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

6 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

4 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 50526 (SMART IRB)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

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

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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