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NCT Number: NCT07749521

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

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.

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Key information

Conditions

Depression / Major Depressive Disorder Behavior Behavioral Symptoms Conduct Disorders in Children Depression Depressive Disorder Depressive Disorder, Major Disruptive Behaviour in Children Mental Disorders Mood Disorders Parenting Intervention

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ontario Institute for Studies in Education (OISE)

Toronto, Ontario, Canada

Location status: Recruiting

Location contact

Madison Moloney

CONTACT

[email protected]

416-535-8501 ext. 30525

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

ADAPT Treatment

Behavioral

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.

Incredible Years Parenting Program (IYPP)

Behavioral

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.

Primary outcomes

  1. Changes in child emotional and behavioral difficulties

    Time frame: 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).

Secondary outcomes

  1. Changes in parental depression

    Time frame: 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).

  2. Changes in parental quality of life

    Time frame: 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).

  3. Changes in broad parenting practices

    Time frame: 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).

  4. Changes in parental stress

    Time frame: 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).

Other outcomes

  1. Changes in parental cognition

    Time frame: 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.

  2. Changes in parent emotion regulation

    Time frame: 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.

  3. Changes in real-time parent-reported child emotional and behavioral difficulties

    Time frame: 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.

  4. Changes in the implementation of parenting skills

    Time frame: Baseline (pre-randomization) and post-treatment (12-weeks post-randomization).

    Implementation of parenting skills is assessed using the Parenting Skill Use Diary (PSUD).

  5. Changes in child depressive symptoms

    Time frame: 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).

  6. Changes in child irritability

    Time frame: 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).

  7. Changes in child perceptions of parenting behaviour

    Time frame: 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).

  8. Changes in parental competence need satisfaction and frustration

    Time frame: 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).

  9. Changes in child callous-unemotional traits

    Time frame: 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).

  10. Changes in child self-reported emotion-regulation

    Time frame: 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).

  11. Changes in parental self-efficacy

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Brendan Andrade, PhD

CONTACT

[email protected]

416-946-5905

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Collaborators

  • Centre for Addiction and Mental Health
  • Women's College Hospital

Registry information

Official study title

Optimizing Treatment for Depressed Parents of Children With Emotional and Behavioural Problems (OPTED): A Randomized and Controlled Trial

Acronym: OPTED

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Aug 6, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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