NCT07083037 Enhancing Preschool Children's Attention and Behaviour: Parent-Focused Program
| NCT ID | NCT07083037 |
| Status | Recruiting |
| Phase | — |
| Sponsor | McGill University |
| Condition | Maternal Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-02-01 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07083037 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Maternal Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07083037 currently recruiting?
Yes, NCT07083037 is actively recruiting participants. Contact the research team at tasmia.hai@umanitoba.ca for enrollment information.
Where is the NCT07083037 trial being conducted?
This trial is being conducted at Winnipeg, Canada, Montreal, Canada.
Who is sponsoring the NCT07083037 clinical trial?
NCT07083037 is sponsored by McGill University. The trial plans to enroll 60 participants.
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