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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Toronto

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Parent shows active suicidal ideation, substance use disorder, or psychosis

they cannot communicate in English

child previously diagnosed with autism or an intellectual disability

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: ADAPT TreatmentExperimental treatment 1 intervention
Group B: Incredible Years Parenting Program (IYPP)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Changes in child emotional and behavioral difficulties

Child emotional and behavioural difficulties are assessed using the Behaviour and Feelings Survey (BFS).

Time frame
Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up

Secondary outcomes

1

Changes in parental depression

Parental depression is assessed using the Patient Health Questionnaire (PHQ-8).

Time frame
Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
2

Changes in parental quality of life

Quality of life is assessed using the World Health Organization Disability Assessment 2.0 (WHODAS).

Time frame
Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
3

Changes in broad parenting practices

Parenting practices are assessed using the Multidimensional Assessment of Parenting (MAPS).

Time frame
Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
4

Changes in parental stress

Parental stress is assessed using the self-reported scores on items of the Stress subscale of the Depression, Anxiety, and Stress Scale (DASS-21).

Time frame
Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up

Other outcomes

1

Changes in parental cognition

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.

Time frame
Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
2

Changes in parent emotion regulation

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.

Time frame
Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
3

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

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.

Time frame
Baseline (pre-randomization) and post-treatment (12-weeks post-randomization)
4

Changes in the implementation of parenting skills

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

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

Sponsors and contacts

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University of Toronto

Lead sponsor

Centre for Addiction and Mental Health

Collaborator

Women's College Hospital

Collaborator