Trials / Recruiting

RecruitingNCT07083037

Enhancing Preschool Children's Attention and Behaviour: Parent-Focused Program

Status: Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 60 (estimated)

Sponsor: McGill University · Academic / Other
Sex: Female
Age: 18 Years
Healthy volunteers: Accepted

Summary

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. 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. The investigators 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). The investigators will also examine parenting stress (secondary outcome). 3. Identify predictors of academic readiness skills in preschool and young children. The investigators 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.

Detailed description

Early exposure to parents' psychological distress and mental health challenges (e.g. elevated depression, anxiety, sleep problems and parenting stress) is a crucial risk factor for the development of children's own difficulties through the intergenerational transmission of a maternal mental health framework. 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. 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 the investigator's 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. The investigators 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. The investigator's 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. The investigator's 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.

Conditions

Interventions

Type	Name	Description
BEHAVIORAL	Building Regulation in Dual Generations (BRIDGE; DBT + Parenting)	The BRIDGE intervention includes 12 weeks of 20-60-minute DBT and parenting skills training videos, delivered asynchronously via an online website requiring a participant login. Video content was drawn from concepts outlined in the DBT Skills Training Manual 2nd Edition (Linehan, 2015). Parenting videos will provide mothers with parenting skills education based on best practices in evidence-based positive parenting interventions (e.g., Parent Management Training, Positive Parenting, Kazdin, 1997; Sanders et al., 2014). The BRIDGE condition also includes weekly synchronous 1-hour virtual group therapy sessions and worksheets to complete weekly (as an opportunity to practice skill use).

Timeline

Start date: 2025-02-01
Primary completion: 2027-07-31
Completion: 2027-08-31
First posted: 2025-07-24
Last updated: 2026-04-08

Locations

2 sites across 1 country: Canada

Source: ClinicalTrials.gov record NCT07083037. Inclusion in this directory is not an endorsement.