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

NCT07083037 | Recruiting

• 2 other identifiers: 24-06-073430-2024-00718
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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. 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. 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. 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.

Conditions

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

Keywords

maternal depression; child attention problems; child behaviour problems; parental stress

Outcome Measures

Primary Outcomes (4)

• Changes in child mental illness symptoms

  Changes in child mental illness symptoms will be assessed using the Child Behavior Checklist (CBCL) for ages 1.5-5 and 6-18. The CBCL is a parent-report questionnaire that measures child functioning across internalizing and externalizing symptoms. The CBCL contains 100 items, with scores ranging from 0-200. Higher scores indicated greater symptom severity. We will be analyzing changes in children's A) Total problem behaviors B) ADHD problems subscale scores C) Internalizing behaviors D) Externalizing Behaviors

  The CBCL 1.5-5 and 6-18 will be assessed during eligibility screening (T0), pre-intervention (T1), within a month following the intervention (T2), and at 3-month follow-up (T3).

• Changes in parent report measures of their children's executive function skills

  Changes in children's executive functioning skills will be measured using the Behavior rating Inventory of Executive Function - Preschool Edition (BRIEF-P) or Behavior rating Inventory of Executive Function - Second Edition. The BRIEF-P is a 63-item parent-report measure and it assesses executive functioning in young children (ages 2-5) across five key areas: Inhibit, Shift, Emotional Control, Working Memory, and Plan/Organize, evaluating skills such as impulse control, emotional regulation, flexibility, and memory for tasks. The BRIEF-2 is a 63-item parent-report measure and is designed for older children (ages 5-18). It includes similar scales, as well as additional ones such as Initiate, Self-Monitor, and Organization of Materials, to capture more complex executive functions required in school and daily life. Both scales' scores range from 63 to 189. Higher scores reflect more frequent or severe executive functioning difficulties.

  Assessed at pre-intervention (T1) and within a month following the intervention (T2), and at 3-month follow-up (T3).

• Changes in maternal mental health symptoms

  Depressive symptoms will be measured using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item self-report questionnaire with possible scores ranging from 0 to 27, with higher scores indicating greater symptom severity.

  The PHQ-9 will be assessed during eligibility screening (T0) , pre-intervention (T1), immediately after the intervention (T2), and at 3-month follow-up (T3).

• Program Engagement

  Program engagement will be assessed in a variety of ways. Clinicians will take attendance during therapy sessions. At post-intervention, the investigators will ask participants to report on their use of the videos and homework assignments throughout the intervention. Participants will also complete a program acceptability questionnaire at post-intervention, which was created by the investigators for this project. The program acceptability questionnaire asks participants to rate how important various program components were to them and includes several open-ended questions for participants to describe their experiences in the program.

  Attendance is measured weekly throughout the 12-week program and immediately after the intervention (T2).

Secondary Outcomes (2)

• Changes in parenting stress

  Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 3-month follow-up (T3).

• Changes in harsh parenting

  Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 3-month follow-up (T3).

Other Outcomes (13)

• Changes in maternal anger

  Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 3-month follow-up (T3).

• Changes in maternal sleep problems

  Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 3-month follow-up (T3).

• Changes in anxiety symptoms

  Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 3-month follow-up (T3).

Study Arms (2)

BRIDGE arm

EXPERIMENTAL

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.

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

Support As Usual

NO INTERVENTION

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.

Interventions

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

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).

BRIDGE arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants who self-identify as a mother or female primary caregiver (e.g., grandmothers raising grandchildren, gender diverse caregivers who identify as mothers) will be eligible to participate. The terms "mother" or "maternal" will be used throughout reports to describe all participants.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BRIDGE Therapy Group:
• Participants are deemed eligible for the BRIDGE therapy group if they meet the following criteria:
• Above the age of 18.
• Self-identify as a mother of a child between the age of 3-7 years old.
• Currently living in Quebec, Ontario, or Manitoba
• Fluency in English.
• 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.
• 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:
• Above the age of 18
• Self-identify as a mother of a child between the age of 3-7 years old
• Currently living in Quebec, Ontario, or Manitoba
• Fluency in English or bilingual
• Mothers must NOT have clinically significant symptoms of depression (mild to moderate on the Patient Health Questionnaire)

You may not qualify if:

• BRIDGE Therapy Group:
• 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:

Sponsors & Collaborators

• McGill University: lead
• University of Manitoba: collaborator
• Social Sciences and Humanities Research Council of Canada: collaborator

Study Sites (2)

University of Manitoba - Department of Psychology

Winnipeg, Manitoba, R3T 2N2, Canada

ENROLLING BY INVITATION

McGill University - Department of Education and Counselling Psychology

Montreal, Quebec, H3A 1G1, Canada

RECRUITING

Related Publications (4)

• Penner-Goeke L,Belows M,Kristjanson A,Andrade BF,Cameron EE,Giuliano R,Katz LY,Kelly LE,Letourneau N,Mota N,Reynolds K,Zalewski M,Pharazyn A,Roos LE

  BACKGROUND

• Landstedt E,Almquist YB

  BACKGROUND

• Brikell I, Kuja-Halkola R, Larsson H. Heritability of attention-deficit hyperactivity disorder in adults. Am J Med Genet B Neuropsychiatr Genet. 2015 Sep;168(6):406-413. doi: 10.1002/ajmg.b.32335. Epub 2015 Jun 30.

  PMID: 26129777 BACKGROUND

• Bridgett DJ,Burt NM,Edwards ES,Deater-Deckard K

  BACKGROUND

MeSH Terms

Conditions

Emotional Regulation; Neurodevelopmental Disorders; Mental Disorders

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Central Study Contacts

Tasmia Hai, PhD

CONTACT

204-474- 8258; tasmia.hai@umanitoba.ca

Kayley Leurquin, BA Hons

CONTACT

kayley.leurquin@umanitoba.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The study will recruit a group of caregivers who meet the current criteria for elevated symptoms of psychological distress as measured by a score of 5 and indicate symptoms to "somewhat cause difficulties" above on the Patient Health Questionnaire 9-item, AND who have children with elevated levels of attention and/or behavior problems as measured by a CBCL ADHD subscale T-Score score of \> 65 OR confirmation of attention/behavior problems through a clinical interview. Eligible female caregivers (mothers, grandmothers, aunts, guardians) will be recruited, and the recruitment will occur concurrently over 12 weeks, will incorporate intervention materials from Dialectical Behavior Therapy (DBT) and parent skills training (BRIDGE).

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 24, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

CA (2)