Enhancing Preschool Children's Attention and Behaviour: Parent-Focused Program (BRIDGE-McGill)

McGill University

Status: Enrolling

Conditions: Child Development; Maternal Depression; Behaviour Problems; Parental Stress; Self-Regulation, Emotion; Attention Problems; Child Mental Disorder

Treatments: Behavioral: Building Regulation in Dual Generations (BRIDGE; DBT + Parenting)

Study type: Interventional

Funder types: Other

Identifiers

NCT07083037

430-2024-00718 (Other Grant/Funding Number)

24-06-073

Details and patient eligibility

About

This study aims to evaluate the feasibility and efficacy of the Building Regulation in Dual Generations (BRIDGE) program for caregivers with significant mental health concerns and preschool and young children (3-7 years old) with elevated attention and/or behavior problems. The BRIDGE program focuses on supporting parental psychological distress and improving young children's self-regulation (SR), thereby reducing their attention and behavior problems (Bridgett et al., 2015; Brikell et al., 2015; Landstedt and Almquist, 2019). The long-term goal of this work is to improve family well-being and social-emotional development for young children by implementing an accessible and scalable dual-regulation program. We will achieve this through the following key objectives:

1. Assess the feasibility and accessibility of BRIDGE for preschool and young children (3-7 years old) with significant attention and behavior programs through questionnaires asking about attendance, satisfaction, and unmet needs.
2. Examine the efficacy of BRIDGE compared to control group at improving maternal mental health and child attention and behavioral difficulties in young children (primary outcomes). We will also examine parenting stress (secondary outcome).
3. Identify predictors of academic readiness skills in preschool and young children. We hypothesize that an increase in parental and child emotion-regulation skills and reduced attention, as well as behavioral problems, will lead to increased pre-academic skills in children.

Full description

Early exposure to parent psychological distress and mental health challenges (e.g. elevated depression, anxiety, sleep problems and parenting stress) is as a crucial risk factor for the development of children's own difficulties through the intergenerational transmission of maternal mental health framework (Landstedt and Almquist, 2019). The Building Regulation in Dual Generations (BRIDGE) program was designed to improve maternal mental health challenges (e.g. depression, anxiety, trauma, stress) and promote positive parenting thereby improving child behavior and mental health. It brings together evidence-based programs, including Dialectical Behavior Therapy (DBT), behavior management, emotion socialization and mindfulness parenting strategies, and has made significant improvement in maternal depression, as well as the mental health of their children, with greater changes observed in mothers with higher psychological distress (Penner-Goeke et al., 2023).

This project addresses a gap in the current literature by focusing on parent-focused support for preschool and young children with attention and behavior problems. It aims to empower parents with tools and strategies to positively impact their children's behavior. The expected contribution includes understanding effective family-focused supports that address both parental and child challenges early on, promoting positive family well-being. This research has broader implications for clinicians, educators and policymakers by offering practical strategies to improve young children's' behaviors and manage parental mental health challenges, ultimately enhancing overall child well-being and aligning with broader goals in child development and early education. The results will be disseminated through academic publication, and directly communicated within our network of community agencies, programs, clinics and school-systems in both Quebec, Ontario and Manitoba.

The current study will conduct a non-randomized parallel assignment feasibility pilot design to evaluate the feasibility and potential efficacy of the BRIDGE program in addressing parents' mental health difficulties and children's attentional and behavioral problems. We aim to recruit sixty parent-child dyads (30 participants and 30 controls) to take part in the study. Participants in the intervention group will complete the 12-week online BRIDGE program, along with in-person assessments at three time points: pre-intervention (week 0-1;T1), post-intervention (week 12; T2), and follow-up (3 months; T3). The control group will complete the same in-person assessments without participating in the intervention.

Our primary aim is to examine the feasibility of BRIDGE on maternal mental health and their children's mental wellbeing, executive functioning, and social-emotional development. Our secondary aims are to evaluate the efficacy of BRIDGE therapy in improving parenting stress and decreasing harsh parenting tendencies. Supplementary aims of this study include observing differences or changes for both mothers and children, in sleep quality, mental wellbeing, relationships, as well as child academic readiness before and after the BRIDGE program.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

BRIDGE Therapy Group:

Participants are deemed eligible for the BRIDGE therapy group if they meet the following criteria:

1. Above the age of 18.
2. Self-identify as a mother of a child between the age of 3-7 years old.
3. Currently living in Quebec, Ontario, or Manitoba
4. Fluency in English.
5. Mothers must have clinically significant symptoms of depression (mild to moderate on the Patient Health Questionnaire and indicate symptoms to "somewhat cause difficulties") currently affecting them. Participants also need to report symptoms of depression during pregnancy or shortly after birth.
6. Their child has attention and/or behavior problems (T-score > 65 on the Child Behavior Checklist (CBCL) ADHD subscales) or confirmed attention and/or behavior problems through clinical interview.

Control Group:

Participants are deemed eligible for the Control group if they meet the following criteria:

1. Above the age of 18
2. Self-identify as a mother of a child between the age of 3-7 years old
3. Currently living in Quebec, Ontario, or Manitoba
4. Fluency in English or bilingual
5. Mothers must NOT have clinically significant symptoms of depression (mild to moderate on the Patient Health Questionnaire)
6. Their child DOES NOT have attention and/or behavior problems (T-score > 65 on the Child Behavior Checklist (CBCL) ADHD subscales).

Exclusion criteria

BRIDGE Therapy Group:

Participants were excluded if they A) did not meet the inclusion criteria listed above or B) were unable to attend the weekly BRIDGE group therapy sessions.

Furthermore, eligible participants were invited to complete a semi-structured intake interview with principal investigator (PI) Dr. Tasmia Hai or a graduate student trainee under Dr. Hai's supervision, during which further questions about their mental health and child behavior were asked to ensure their eligibility. Based on the clinical suitability interview, participants may be excluded if they are deemed to be ineligible based on A) the mother's absence of clinically significant mental health symptoms, and/or B) the child's absence of attention and/or behavior problems. When relevant, participants may be identified to participate in the control group instead if eligibility is met.

Control Group:

Participants were excluded if they did not meet the inclusion criteria listed above. Furthermore, eligible participants were invited to complete a semi-structured intake interview with principal investigator (PI) Dr. Tasmia Hai, during which further questions about their mental health and child behavior were asked to ensure their eligibility. Based on the clinical suitability interview, participants may be excluded if they are deemed to be ineligible based on a) the mother's presence of clinically significant mental health symptoms, and/or B) the child's presence of attention and/or behavior problems. When relevant, participants may be identified to participate in the BRIDGE therapy group instead if eligibility is met.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

BRIDGE arm

Experimental group

Description:

The BRIDGE program is a manualized therapy program that provides participants with parenting and DBT skills through video training modules and in-group sessions. Participants in the BRIDGE arm will participate in 12 weeks of 20-60-minute DBT and parenting skills training that will be delivered asynchronously via video (participants will access these by logging onto a password-protected website). The BRIDGE condition also includes weekly synchronous 1-hour virtual group therapy sessions as well as DBT and parenting skills worksheets to complete between sessions.

Treatment:

Behavioral: Building Regulation in Dual Generations (BRIDGE; DBT + Parenting)

Support As Usual

No Intervention group

Description:

Control group participants in the SAU arm will receive a list of local mental health and parenting resources, curated by our research team. Participants can access any intervention or resource participants would like throughout the duration of the program.