NCT05796466

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
50mo left

Started Apr 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Apr 2023Jun 2030

First Submitted

Initial submission to the registry

March 4, 2023

Completed
28 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2023

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2030

Last Updated

June 3, 2024

Status Verified

May 1, 2024

Enrollment Period

6.2 years

First QC Date

March 4, 2023

Last Update Submit

May 31, 2024

Conditions

Mental Health IssueParenting

Keywords

Parenting program

Outcome Measures

Primary Outcomes (2)

  • Change in children's externalizing problems

    Parents will complete the externalizing scale of the Child Behavior Checklist (Achenbach et al. 2001) for ages 1.5 to 5. The scale is answered on a 3-anchor rating scale ranging from "does not apply (as far as you know)" to "always or often applies". The externalizing scale comprises 24 items on aggressive and attention problems.

    Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.

  • Change in parental autonomy support

    Parents will answer seven items of the Parental Attitude Scale (Grolnick et al., 1997) to rate their attitude toward autonomy support and controlling parenting. This scale has predictive validity and has been associated with observational measures of autonomy-supportive and controlling behaviors. The scale is answered on a 7-anchor Likert scale ranging from "do not agree at all" to "very strongly agree".

    Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.

Secondary Outcomes (10)

  • Change in observed parenting practices

    Baseline and 8-month follow-up.

  • Change in observed child committed compliance

    Baseline and 8-month follow-up.

  • Change in children's socio-emotional competencies

    Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.

  • Change in children's internalizing problems

    Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.

  • Change in parental self-compassion

    Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.

  • +5 more secondary outcomes

Other Outcomes (6)

  • Change in parental perspective taking

    Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.

  • Change in parental emotional regulation

    Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.

  • Change in parental social cohesion

    Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.

  • +3 more other outcomes

Study Arms (2)

How-to Parenting Program

EXPERIMENTAL

The How-to Parenting Program is a highly structured and skill-based program. It is manualized, teaches 30 concrete, specific, easy-to-grasp (e.g., taught using comic strips), and readily applicable skills. It also optimizes learning with exercises (e.g., perspective taking; role-playing) and practice, and addresses parents' readiness and motivation to change. The program is delivered over six consecutive 2-hour weekly sessions (12 hours in total).

Behavioral: How-to talk so kids will listen and listen so kids will talk

Nobody's Perfect Program

ACTIVE COMPARATOR

Based on andragogy principles, parents following the Nobody's Perfect curriculum will learn how to solve problems with their child and engage in theme-related activities meant to increase awareness of parents' own needs, child behaviors, development, health, and safety. There is no pre-determined order for themes and time devoted to each one varies according to parents' needs. The program is delivered over six consecutive 2-hour weekly sessions (12 hours in total).

Behavioral: Nobody's Perfect

Interventions

How-to talk so kids will listen and listen so kids will talkBEHAVIORAL

The How-to Parenting Program focuses on how expectations, rules, and values are better communicated (vs. what rules ought to be). It includes skills related to the three components of authoritative parenting, namely affiliation, structure, and autonomy support. 1) Affiliation: Parents learn how to listen and respond to their children in a way that helps them feel accepted unconditionally. 2) Structure: Parents learn how to communicate expectations, give feedback, follow through, and use joint problem-solving in a factual, non-judgmental way. 3) Autonomy support: Parents learn how to validate emotions, encourage initiatives, and free children from roles. Finally, the How-to program can be endorsed by parents of various cultural backgrounds, as suggested by the large number (\> 30) of languages in which the material is translated. This advantage is crucial in ethnically diverse regions such as Canada.

Also known as: How-to Parenting Program
How-to Parenting Program
Nobody's PerfectBEHAVIORAL

Nobody's Perfect is delivered in family resource centers across Canada to support parents of infants and preschoolers. Its focus is on developing parents' capacity to problem solve, providing child development information, and helping parents recognize their strengths and find their own positive ways to interact with their children. It thus does not teach specific parenting skills and does not suggest specific rules to put into practice in the home-environment.

Nobody's Perfect Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université de Montréal

Montreal, Quebec, Canada

RECRUITING

Related Publications (1)

  • 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.

    PMID: 30071843BACKGROUND

Related Links

Study Officials

  • Joussemet Mireille, Ph.D.

    Université de Montréal

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mireille Joussemet, Ph.D.

CONTACT

514 343-5745m.joussemet@umontreal.ca

Mageau Geneviève, Ph.D.

CONTACT

514 343-2460g.mageau@umontreal.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Participants will only know the name of the parenting program they are taking part of, but the name of the other program will not be disclosed. All research assistants who will conduct evaluations (i.e., observational tasks) or code parent-child interactions will be blind to experimental assignment.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 4, 2023

First Posted

April 3, 2023

Study Start

April 1, 2023

Primary Completion (Estimated)

June 15, 2029

Study Completion (Estimated)

June 15, 2030

Last Updated

June 3, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

Individual participant data is not planned to be openly available, yet the study is open to collaboration and shared initiatives.

Locations

CA(1)