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View on ClinicalTrials.gov

Comparing How-to talk so kids will listen and with Nobody's Perfect for mental health issue

Official title: Improving Preschoolers' Mental Health: A RCT Assessing Two Parenting Programs

Improving Vulnerable Preschoolers' Mental Health: A Superiority Trial Assessing the How-to Parenting Program

Condition: Mental Health IssueSponsor: Mireille JoussemetTarget enrollment: 320
  • 2 groups
  • One site, in Montreal
  • Recruiting
Université de Montréal, Montreal, Quebec

Interventions

  • Behavioural therapy

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

    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.

  • Behavioural therapy

    Nobody's Perfect

    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.

Canadian Sites (1)

1 of 1 recruiting

  • Université de Montréal

    Montreal, Quebec

    Recruiting

Eligibility Criteria

See who this study is looking for5 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

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

Exclusion

  • 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.
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a way to prevent a condition from developing.

This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 2 groups in this study.

Group A receives How-to talk so kids will listen and listen so kids will talk.

Registry label: A: How-to Parenting Program

Group B, the comparison group, receives Nobody's Perfect.

Registry label: B: Nobody's Perfect Program

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

One group of people involved — usually the participants — is not told which treatment is which.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives an existing treatment, so the two can be compared.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists a minimum age of 18 years, with no upper limit given.

The study is open to people of any sex.

The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 320 people.

The study is currently expected to finish around June 2030.

The main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, 2-month follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →, 8-month follow-up, and 14-moth follow-up.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Change in children's externalizing problems — measured over BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, 2-month follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →, 8-month follow-up, and 14-moth follow-up.

Change in parental autonomy support — measured over Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT05796466 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About How-to talk so kids will listen and listen so kids will talkBehavioural

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.

From the trial registry — its own words, unedited.

What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.

Read the full explanation → · in clinical review

About Nobody's PerfectBehavioural

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.

From the trial registry — its own words, unedited.

What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: a minimum age of 18 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives an existing treatment so the two can be compared.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

One group of people involved — usually the participants — is not told which treatment is which.

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists a minimum age of 18 years, with no upper limit given.

It is open to people of any sex.

It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, 2-month follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →, 8-month follow-up, and 14-moth follow-up..

The study as a whole is currently expected to finish around 2030-06-15.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 320 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists one location: Montreal, Quebec, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About This Trial

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.

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.