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

4 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

180

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Werving
        • Ontario Institute for Studies in Education (OISE)
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: 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.
Actieve vergelijker: 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.
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Changes in child emotional and behavioral difficulties
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Changes in parental depression
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Changes in parental cognition
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Toronto

Medewerkers

Centre for Addiction and Mental Health
Women's College Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 augustus 2026

Primaire voltooiing (Geschat)

1 augustus 2030

Studie voltooiing (Geschat)

1 augustus 2030

Studieregistratiedata

Eerst ingediend

8 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

4 augustus 2026

Eerst geplaatst (Werkelijk)

6 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

4 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 50526 (SMART IRB)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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