Clinical trial NCT05796466: Improving Preschoolers' Mental Health: A RCT Assessing Two Parenting Programs
Official title: Improving Vulnerable Preschoolers' Mental Health: A Superiority Trial Assessing the How-to Parenting Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health Issue
Parenting
Keywords: Parenting program
Lead sponsor: Université de Montréal
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2023-04-03
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

- Parents need to have at least one child aged between between 36 and 59 months at pre-intervention.

Exclusion Criteria:

* Parents will be excluded if they have previously attended a How-to Parenting Program
* Parents who are unable to communicate in French will be excluded.

Recruitment procedure:

- To target more more vulnerable families, parents will primarily be recruited in ECCs located in low- or middle-income neighbourhoods of the greater Montreal (Canada) according to the Montreal's 2018 Poverty Map of Families with Children.

Primary outcomes:
measure: Change in children's externalizing problems
timeFrame: Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.
measure: Change in parental autonomy support
timeFrame: Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.
Secondary outcomes:
measure: Change in observed parenting practices
timeFrame: Baseline and 8-month follow-up.
measure: Change in observed child committed compliance
timeFrame: Baseline and 8-month follow-up.
measure: Change in children's socio-emotional competencies
timeFrame: Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.
measure: Change in children's internalizing problems
timeFrame: Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.
measure: Change in parental self-compassion
timeFrame: Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.
measure: Change in parental efficacy
timeFrame: Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.
measure: Change in parental guilt
timeFrame: Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.
measure: Change in parental stress
timeFrame: Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.
measure: Change in parental social support
timeFrame: Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.
measure: Change in parental problem solving strategies
timeFrame: Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.
Other outcomes:
measure: Change in parental perspective taking
timeFrame: Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.
measure: Change in parental emotional regulation
timeFrame: Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.
measure: Change in parental social cohesion
timeFrame: Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.
measure: Change in autonomy-supportive practices
timeFrame: Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.
measure: Change in parental affiliation
timeFrame: Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.
measure: Change in parental structure
timeFrame: Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.
Locations:
city: Montréal
country: Canada
facility: Université de Montréal
state: Quebec
Study officials:
affiliation: Université de Montréal
name: Joussemet Mireille, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Joussemet M, Mageau GA, Larose MP, Briand M, Vitaro F. How to talk so kids will listen & listen so kids will talk: a randomized controlled trial evaluating the efficacy of the how-to parenting program on children's mental health compared to a wait-list control group. BMC Pediatr. 2018 Aug 2;18(1):257. doi: 10.1186/s12887-018-1227-3.