Optimizing Treatment for Depressed Parents of Children With Emotional and Behavioural Problems (OPTED): A Randomized and Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Toronto
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Changes in child emotional and behavioral difficulties
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: ADAPT Treatment (Behavioral)
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.
Intervention: Incredible Years Parenting Program (IYPP) (Behavioral)
Outcomes
Primary Outcomes
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
- Changes in parental depression(Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up)
- Changes in parental quality of life(Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up)
- Changes in broad parenting practices(Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up)
- Changes in parental stress(Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up)
Investigators
Brendan Andrade
Associate Professor
University of Toronto