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Recruiting NCT07749521

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

No phase Interventional Depression / Major Depressive Disorder Conduct Disorders in Children Disruptive Behaviour in Children Parenting Intervention

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ADAPT Treatment, Incredible Years Parenting Program (IYPP).
Who it may be relevant to
Registry conditions: Depression / Major Depressive Disorder, Conduct Disorders in Children, Disruptive Behaviour in Children, Parenting Intervention. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Behavioral 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 t
  • Behavioral 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.

Primary outcome measures

  • Changes in child emotional and behavioral difficulties [Time frame: Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up]
Secondary outcome measures (4)
  • Changes in parental depression [Time frame: Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up]
  • Changes in parental quality of life [Time frame: Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up]
  • Changes in broad parenting practices [Time frame: Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up]
  • Changes in parental stress [Time frame: Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Ontario Institute for Studies in Education (OISE) — Toronto

Identifiers

NCT: NCT07749521 · 50526

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗