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

tiistai 4. elokuuta 2026 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Rekrytointi

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Arvioitu)

180

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

Opiskelupaikat

  • Kanada
    • Ontario
      • Toronto, Ontario, Kanada
        • Rekrytointi
        • Ontario Institute for Studies in Education (OISE)
        • Ottaa yhteyttä:

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Aikuinen
  • Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Ei

Kuvaus

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

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Kaksinkertainen

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: 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.
Käyttäytyminen: 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.
Active Comparator: 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.
Käyttäytyminen: 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.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Changes in child emotional and behavioral difficulties
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Changes in parental depression
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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

Muut tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Changes in parental cognition
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

University of Toronto

Yhteistyökumppanit

Centre for Addiction and Mental Health
Women's College Hospital

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

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Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • 50526 (SMART IRB)

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

JOO

IPD-suunnitelman kuvaus

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

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