Viewing Study NCT05796466


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Study NCT ID: NCT05796466
Status: RECRUITING
Last Update Posted: 2024-06-03
First Post: 2023-03-04
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Improving Preschoolers' Mental Health: A RCT Assessing Two Parenting Programs
Sponsor: Mireille Joussemet
Organization:

Study Overview

Official Title: Improving Vulnerable Preschoolers' Mental Health: A Superiority Trial Assessing the How-to Parenting Program
Status: RECRUITING
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The goal of this randomized control trial (RCT) is to assess the superiority of the How-to Parenting Program in improving autonomy support and preschoolers' mental health (i.e., decreases externalizing problems) among vulnerable families. The main question it aims to answer is: Can teaching concrete parenting skills that target empirically-based parenting dimensions (via the How-to Parenting Program) have an added value for improving parental autonomy support and child mental health, compared to a parenting program that does not focus on teaching parenting skills (Nobody's Perfect program \[NP\])? Early childhood centers providing services to parents of 3-4 years olds will be randomly assigned to one of two 6-week programs. Parents will fill out questionnaires before (T1) and after (T2) programs delivery as well as at 6-month (T3) and 1-year follow-ups (T4). They and their child will also engage in filmed parent-child interactions at T1 and T3 during predetermined activities, to obtain observational measures of parenting and child socioemotional competences. Researchers will compare the How-to and NP conditions to see if there was an accentuated increase in parental autonomy support and child mental health in the How-to condition. As secondary analyses, researchers will compare the How-to and NP conditions on parenting quality, child socioemotional competences, and parental cognitions as well as explore the conditions in which NP could be equal (or superior) to the How-to Parenting Program.
Detailed Description: This RCT with a 1-year follow-up aims to assess the superiority of the How-to Parenting Program in improving parental autonomy support and preschoolers' mental health (i.e., decreases externalizing problems) among vulnerable families. One out of five children younger than age 7 presents mental disorders. Without proper help, such difficulties impede later health and functioning, making early intervention aimed to reduce mental health problems a social imperative.

Among environmental factors, parenting quality is the most widely accepted predictor of child mental health. Decades of parenting research show that parenting quality has three components fostering child development and mental health: affiliation, structure, and autonomy support. Investigators aim to assess the impact of the How-to Parenting Program, an accessible program that addresses all components of parenting quality. Reseacrhers will compare it to the Nobody's Perfect (NP) program, a program delivered in communities across Canada that is similar in format (6 weekly group sessions), similar in cost (no costly certification), but different in content (NP does not focus on parenting skills).

In a prior wait-list RCT with school-aged children, investigators found that the How-to Parenting Program improved both parenting quality and child mental health. The present RCT aims to test whether teaching concrete parenting skills that target empirically-based parenting dimensions (via the How-to Parenting Program) improves parental autonomy support and the mental health of younger children to a greater extent than the NP Program.

Investigators will recruit 320 parents of 3- and 4-year-olds from a large pool of early childhood centers (ECCs; i.e., family resource centers and daycares). At each of five yearly waves, ECCs will be randomized to the experimental condition (4 How-to groups; ≈ 32 parents) or the active control condition (4 NP groups; ≈ 32 parents). Parents will fill out questionnaires before (T1) and after programs delivery (T2) and at 6-month (T3) and 1-year follow-ups (T4). Both programs will be delivered online, by two trained facilitators. Parents, blind to their condition allocation, will rate their child's mental health problems and their autonomy-supportive behaviors (primary outcomes) as well as their child's socio-emotional competencies, and other parental behaviors and cognitions. Parent-child filmed interactions will allow observational measures of child self-regulated behaviors and parenting quality). Based on prior findings, investigators expect greater improvements in parental autonomy support and child mental health in the How-to condition compared to the NP condition. Investigators also expect larger improvements on secondary outcomes in the How-to condition, with the exception of the parental cognitions specifically targeted by NP (problem-solving; social support). Finally, researchers expect both programs to have similar benefits for among more vulnerable parents.

By evaluating the added benefits of the How-to Parenting Program, this research will reduce the know-do gap, helping practitioners and other stakeholders to make evidence-based decisions regarding the delivery of helpful parenting interventions to improve preschoolers' mental health.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: