Mental Health IssueNCT05796466
Improving Preschoolers' Mental Health: A RCT Assessing Two Parenting Programs
A study testing How-to talk so kids will listen and listen so kids will talk and Nobody's Perfect in people with Mental Health Issue and Parenting, run by Mireille Joussemet at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue, Parenting
- What is being tested?
- How-to talk so kids will listen and listen so kids will talk and Nobody's Perfect
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2023to 15 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parents need to have at least one child aged between between 36 and 59 months at pre-intervention.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Université de Montréal
Montreal, Quebec
Mireille Joussemet, Ph.D., 514 343-5745, m.joussemet@umontreal.ca
Joussemet Mireille, Ph.D.
About this study
Official title: Improving Vulnerable Preschoolers' Mental Health: A Superiority Trial Assessing the How-to Parenting Program
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.
Read the 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.
- Conditions
- Mental Health Issue, Parenting
- Being tested
- How-to talk so kids will listen and listen so kids will talk, Nobody's Perfect
- Keywords
- Parenting program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
How-to talk so kids will listen and listen so kids will talkBehavioural
Also called How-to Parenting Program
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Behavioral: Nobody's Perfect |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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".
Measured: Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.
Secondary outcomes (10)
Change in observed parenting practices
Parents' verbal and non-verbal behaviors will be coded using a time-sampling coding scheme with mutually exclusive categories. To control for parents' propensity toward social interactions, each parenting component will be examined in relation to the number of coded behaviors.
A total of 50 behaviors will be coded (Labelle et al., 2023), selected based on previous coding systems (Eisenberg et al., 2010; Robinson \& Eyberg, 1981; Laurin \& Joussemet, 2017) and past literature (e.g., Reeve, 2009).
Affiliation: Parental sensitive availability/warmth.
Rejection: Cold and rejecting behaviors.
Structure: Feedback (Confirming), non-solicited guidance (Non-solicited questions) \& solicited guidance (Solicited information or hints).
Chaos: Incompetent/chaotic guidance (Misleading guidance)
Autonomy support: Empathic behaviors \& choice (Following child's initiative).
Controlling behaviors: Task-related (Directives) \& psychological control (Task-related criticisms; Orders).
Measured: Baseline and 8-month follow-up.
Change in observed child committed compliance
We will use Kochanska's coding scheme to code committed compliance (eagerly or spontaneously pick up toys, beams or claps hands after putting toys in the box), situational compliance (halfheartedly cooperates after being prompted, attention shifts back to playing), and defiance (ignores parental prompts, negotiations, resistance, and oppositional behaviors).
Measured: Baseline and 8-month follow-up.
Change in children's socio-emotional competencies
Parents will fill the Devereux Early Childhood Assessment (DECA; LeBuffe \& Naglieri, 1999). The DECA is a standardized, norm-referenced, behavior rating scale for ages 2 to 5. It evaluates child social and emotional competences (initiative, self-control, and trust) with 26 items. Parents are asked to respond on a 7-point rating scale (ranging from "almost never" to "almost always") how often their child exhibits specific behaviors.
Measured: Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.
Change in children's internalizing problems
Parents will complete three of the internalizing subscales of the Child Behavior Checklist (Achenbach et al. 2001) for ages 1.5 to 5. Items are answered on a 3-anchor rating scale ranging from "does not apply (as far as you know)" to "always or often applies". The global internalizing score will comprise 25 items, the 3 subscales are anxious/depressed, emotionally reactive, and withdrawn.
Measured: Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.
Change in parental self-compassion
Parents will report their levels of self-compassion with the short version of the Self-Compassion Scale (Raes et al., 2011), which includes 12 items. The items are answered on a 7-anchor scale ranging from "almost never " to "almost always".
Measured: Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.
Change in parental efficacy
Parents will complete the efficacy subscale of the Parenting Sense of Competence scale (PSOC). Parents indicate their level of agreement with each item (e.g. I honestly believe I have all the skills necessary to be a good mother/father to my child) by rating a 7-anchor Likert scale ranging from "do not agree at all" and "very strongly agree".
Measured: Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.
Change in parental guilt
Parents will answer a questionnaire assessing their parental guilt by filling an Expanded Form of the Positive and Negative Affect Schedule (PANAS-X) Guilt subscale (Watson \& Clark, 1991, 1994). The questionnaire includes 6 items and is answered on a 5-anchor scale ranging from "very little or not at all" to "extremely".
Measured: Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.
Change in parental stress
Parents will report the extent to which they experience stress in their daily lives using 4 items of the Perceived Stress Scale (e.g. Have you felt difficulties were piling up so high that you could not overcome them?") by rating a 7-anchor scale ranging from "almost never " to "almost always".
Measured: Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.
Change in parental social support
Parents will answer 4 questions of the Social Provisions Scale (Cutrona \& Russell, 1987) to assess their perceived social support. The items are answered on a 7-anchor Likert scale ranging from "do not agree at all" to "very strongly agree".
Measured: Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.
Change in parental problem solving strategies
Parents will answer 4 questions on the Social Problem-Solving Scale (D'Zurilla, et al., 2002) to assess their problem solving strategies with their child. The items are answered on a 7-anchor scale ranging from "almost never" to "almost always".
Measured: Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start1 Apr 2023
- Primary completion15 Jun 2029 (estimated)
- Study completion15 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mireille Joussemet
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor-investigator, Mireille Joussemet, Université de Montréal
- Investigators
- Joussemet Mireille, Ph.D., Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05796466
- Sponsor's protocol ID
- How-to_preschool
- Status last verified
- May 2024
- First submitted
- 4 Mar 2023
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data is not planned to be openly available, yet the study is open to collaboration and shared initiatives.
Publications
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.
PubMed 30071843
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Vulnerable Preschoolers' Mental Health: A Superiority Trial Assessing the How-to Parenting Program
- ClinicalTrials.gov ID
- NCT05796466
- Acronym / sponsor ID
- How-to_preschool
- Conditions
- Mental Health Issue, Parenting
- Keywords
- Parenting program
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Mireille JoussemetUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 15 Jun 2029 (estimated)
- Study completion
- 15 Jun 2030 (estimated)
- First posted
- 3 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| How-to Parenting Program | Experimental | Behavioral: How-to talk so kids will listen and listen so kids will talkThe 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). |
| Nobody's Perfect Program | Active comparator | Behavioral: Nobody's PerfectBased 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Parents need to have at least one child aged between between 36 and 59 months at pre-intervention.
Key exclusion criteria (4 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| How-to talk so kids will listen and listen so kids will talkAlso: How-to Parenting ProgramThe 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 | How-to Parenting Program |
| Nobody's PerfectNobody'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. | Behavioural | Nobody's Perfect Program |
Primary outcome
Change in children's externalizing problems
Time frame: Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.
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.
Change in parental autonomy support
Time frame: Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.
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".
10 secondary outcomes
Change in observed parenting practices
Time frame: Baseline and 8-month follow-up.
Change in observed child committed compliance
Time frame: Baseline and 8-month follow-up.
Change in children's socio-emotional competencies
Time frame: Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.
Change in children's internalizing problems
Time frame: Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.
Change in parental self-compassion
Time frame: Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.
Change in parental efficacy
Time frame: Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.
Change in parental guilt
Time frame: Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.
Change in parental stress
Time frame: Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.
Change in parental social support
Time frame: Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.
Change in parental problem solving strategies
Time frame: Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Background: PubMed 30071843Joussemet 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.
- Protocol of a waitlist RCT assessing the How-to Parenting Program on school-aged children and their parentsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data is not planned to be openly available, yet the study is open to collaboration and shared initiatives.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joussemet Mireille, Ph.D. principal investigator
Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing How-to talk so kids will listen and listen so kids will talk and Nobody's Perfect in people with Mental Health Issue and Parenting, run by Mireille Joussemet at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mireille Joussemet, Ph.D. (514 343-5745, m.joussemet@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in children's externalizing problems (time frame: Baseline, 2-month follow-up, 8-month follow-up, and 14-moth follow-up.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05796466, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2024.