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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05770427
Other study ID # H-02-23-8888-2
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date June 2023
Est. completion date September 2024

Study information

Verified date May 2023
Source University of Ottawa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date September 2024
Est. primary completion date June 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Make the Connection® Online Program
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.

Locations

Country Name City State
Canada University of Ottawa Ottawa Ontario

Sponsors (1)

Lead Sponsor Collaborator
University of Ottawa

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Parent-child bond will be measured using the Maternal Postnatal Attachment Scale (MPAS) 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 Parent self-efficacy will be measured using the Parent Sense of Competence Questionnaire (PSOC) 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
Secondary Parental stress will be measured using the Parenting Stress Scale (PSS) Change from pre-intervention scores at baseline and post-intervention scores at week 8
Secondary Parental depression will be measured using the Centre for Epidemiological Studies Depression Scale (CES-D) Change from pre-intervention scores at baseline and post-intervention scores at week 8
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