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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07749521
Acronym
OPTED
Enrollment
180
Registered
2026-08-06
Start date
2026-08-01
Completion date
2030-08-01
Last updated
2026-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Conduct Disorders in Children, Depression / Major Depressive Disorder, Disruptive Behaviour in Children, Parenting Intervention

Keywords

behavioural parent training, depression, parenting skills, child disruptive behaviour

Brief summary

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.

Interventions

BEHAVIORALADAPT 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.

BEHAVIORALIncredible 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.

Sponsors

University of Toronto
Lead SponsorOTHER
Centre for Addiction and Mental Health
CollaboratorOTHER
Women's College Hospital
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in child emotional and behavioral difficultiesBaseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-upChild emotional and behavioural difficulties are assessed using the Behaviour and Feelings Survey (BFS).

Secondary

MeasureTime frameDescription
Changes in parental depressionBaseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-upParental depression is assessed using the Patient Health Questionnaire (PHQ-8).
Changes in parental quality of lifeBaseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-upQuality of life is assessed using the World Health Organization Disability Assessment 2.0 (WHODAS).
Changes in broad parenting practicesBaseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-upParenting practices are assessed using the Multidimensional Assessment of Parenting (MAPS).
Changes in parental stressBaseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-upParental stress is assessed using the self-reported scores on items of the Stress subscale of the Depression, Anxiety, and Stress Scale (DASS-21).

Countries

Canada

Contacts

CONTACTBrendan Andrade, PhD
brendan.andrade@utoronto.ca416-946-5905

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 7, 2026