- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05770427
Evaluating an Online Parenting Intervention in a Community-Based Sample of Parents
Can We Still Make the Connection? Evaluating an Online Parenting Intervention in a Community-Based Sample of Parents of Infants and Young Children
The goal of this clinical trial is to evaluate the effectiveness of the online modality of the Make the Connection (MTC) program in a community-based sample of parents not at-risk for parenting difficulties. The main questions it aims to answer are:
- Does the MTC online program result in improvements in parent-child bond, parent self-efficacy, parental stress, and parental depression among parents who are not at-risk for parent-child relationship difficulties?
- What are some of the barriers, facilitators, perceived benefits and risks to participating in the MTC online program from the perspective of parents?
Participants will be asked to complete a pre-intervention questionnaire, will be invited to complete the 8-week MTC online program consisting of a weekly 15-minute module, and will lastly be asked to complete a post-intervention questionnaire.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nicole Racine, PhD, C.Psych
- Phone Number: 403-992-7869
- Email: nracine2@uottawa.ca
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada, K1N 6N5
- University of Ottawa
-
Contact:
- Nicole Racine, PhD, C.Psych
- Phone Number: 403-992-7869
- Email: nracine2@uottawa.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- parents with children between the ages of 0-3 years old
- parents are primarily responsible for the children
Exclusion Criteria:
- parents are at-risk for parent-child relationship difficulties (i.e., endorse two of the following criteria: being a first-time caregiver, socially isolated, low education, caregiving alone, lack of confidence or self-efficacy, at risk for poor infant sensitivity, or at-risk for depression)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
|
Make the Connection® (MTC) is an evidence-based parenting program offered by Strong Minds Strong Kids, Psychology Canada. Recently, the MTC program has been adapted to an online platform to help increase scalability and accessibility across Canada. The online modality is self-administered by parents and consist of 8 weekly, 15-minute modules. MTC is an attachment-focused, evidence-informed, parent training program that is designed to support the development of positive parent-child relationships by teaching parents to understand their infant's cues. The overarching goal of the program is to enhance parental attitudes and cognitions towards their infants, which have been shown to be associated with sensitive parenting behaviour, and in turn, secure child attachment. Ultimately, by improving parenting skills and attitudes, the program seeks to support secure infant attachment. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parent-child bond will be measured using the Maternal Postnatal Attachment Scale (MPAS)
Time Frame: Change from pre-intervention scores at baseline and post-intervention scores at week 8
|
The MPAS is a 19-item questionnaire that assesses parents' relational attitudes towards their infant.
There are three main subscales derived from the measure: Quality of Attachment, Pleasure in Interaction, and Absence of Hostility.
The MPAS has shown strong psychometric properties for use in community samples and can be used with mothers and fathers.
|
Change from pre-intervention scores at baseline and post-intervention scores at week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parent self-efficacy will be measured using the Parent Sense of Competence Questionnaire (PSOC)
Time Frame: Change from pre-intervention scores at baseline and post-intervention scores at week 8
|
The PSOC has 14-items and measures a parent's experiences in their role as a parent.
There are three substances including Interest, Efficacy, and Satisfaction.
The questionnaire has been widely used to assess parenting attitudes and has adequate psychometric properties.
|
Change from pre-intervention scores at baseline and post-intervention scores at week 8
|
Parental stress will be measured using the Parenting Stress Scale (PSS)
Time Frame: Change from pre-intervention scores at baseline and post-intervention scores at week 8
|
Change from pre-intervention scores at baseline and post-intervention scores at week 8
|
|
Parental depression will be measured using the Centre for Epidemiological Studies Depression Scale (CES-D)
Time Frame: Change from pre-intervention scores at baseline and post-intervention scores at week 8
|
Change from pre-intervention scores at baseline and post-intervention scores at week 8
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- H-02-23-8888-2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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