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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMcGill University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: BRIDGE armExperimental treatment 1 intervention
Group B: Support As UsualNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
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).
2

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.

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

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.

Time frame
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).
4

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.

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

Secondary outcomes

1

Changes in parenting stress

Parenting stress will be measured using the Parenting Stress Index-Short Form (PSI-SF). The PSI-SF is a self-report questionnaire that requires respondents to answer questions regarding their overall experience with parenting stress using a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Scores range from 36-180. Higher scores indicate higher levels of stress.

Time frame
Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 3-month follow-up (T3).
2

Changes in harsh parenting

Harsh parenting will be measured using the Overreactivity subscale of the Parenting Scale (PS). The Overreactivity subscale contains 10 items related to harsh parenting behaviors. Harsh parenting includes expressing inappropriate anger, irritability, or meanness towards one's child. Totals scores range from 10 to 70, with higher scores indicating higher levels of harsh parenting.

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

Other outcomes

1

Changes in maternal anger

Changes in anger will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Anger subscale. The subscale contains 5-items with scores ranging from 5-25. Higher scores indicate more anger.

Time frame
Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 3-month follow-up (T3).
2

Changes in maternal sleep problems

The Patient-Reported Outcomes Measurement Information System-Sleep Disturbance Subscale Short Form will be used to measure change in sleep disturbances. The subscale contains 8 items. Total scores range from 8 to 40 with higher scores indicating greater severity of sleep disturbance.

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

Changes in anxiety symptoms

Anxiety symptoms will be measured using the Generalized Anxiety Disorder 7-Item Scale (GAD-7). The GAD-7 contains 7 items with possible scores ranging from 0 to 21. Higher scores represent higher levels of anxiety symptoms.

Time frame
Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 3-month follow-up (T3).
4

Changes in ADHD Symptoms in parents

The Adult ADHD Self Report Scale (ASRS) will be used to measure attention problems and hyperactive behaviours in parents. The ASRS is an 18-item questionnaire that screens for ADHD symptoms in adults, based on DSM criteria. It includes two parts: Part A (6 questions) screens for the most predictive symptoms, while Part B adds more detail. Respondents rate how often they experience symptoms like inattention, impulsivity, and restlessness. The scale has a minimum score of 0 and a maximum score of 72. Higher scores indicate greater severity and frequency of adult ADHD symptoms.

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

Sponsors and contacts

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McGill University

Lead sponsor

University of Manitoba

Collaborator

Social Sciences and Humanities Research Council of Canada

Collaborator