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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

• Changes in child mental illness symptoms [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Attendance is measured weekly throughout the 12-week program and immediately after the intervention (T2).]

Вторичные конечные точки (2)

• Changes in parenting stress [Срок оценки: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 3-month follow-up (T3).]
• Changes in harsh parenting [Срок оценки: Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 3-month follow-up (T3).]

Критерии участия

Критерии включения

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)
• Their child DOES NOT have attention and/or behavior problems (T-score > 65 on the Child Behavior Checklist (CBCL) ADHD subscales).

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 2 центра

• University of Manitoba - Department of Psychology — Winnipeg
• McGill University - Department of Education and Counselling Psychology — Montreal

Публикации

• 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. Protocol for a randomized control trial of the Building Regulation in Dual Generations Program (BRIDGE): preventing the intergenerational transmission of mental illness in at-risk preschool children. Trials. 2023 Sep 19;24(1):597. doi: 1 PMID 37726821
• Landstedt E, Almquist YB. Intergenerational patterns of mental health problems: the role of childhood peer status position. BMC Psychiatry. 2019 Sep 18;19(1):286. doi: 10.1186/s12888-019-2278-1. PMID 31533680
• 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
• Bridgett DJ, Burt NM, Edwards ES, Deater-Deckard K. Intergenerational transmission of self-regulation: A multidisciplinary review and integrative conceptual framework. Psychol Bull. 2015 May;141(3):602-654. doi: 10.1037/a0038662. PMID 25938878

Идентификаторы

NCT: NCT07083037 · 24-06-073 · 430-2024-00718

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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