NCT05770427

Brief 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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 15, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

May 12, 2023

Status Verified

May 1, 2023

Enrollment Period

1 year

First QC Date

February 21, 2023

Last Update Submit

May 10, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Parent self-efficacy will be measured using the Parent Sense of Competence Questionnaire (PSOC)

    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)

    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)

    Change from pre-intervention scores at baseline and post-intervention scores at week 8

Study Arms (1)

Intervention group

EXPERIMENTAL
Behavioral: Make the Connection® Online Program

Interventions

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.

Intervention group

Eligibility Criteria

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

You may qualify if:

  • parents with children between the ages of 0-3 years old
  • parents are primarily responsible for the children

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa

Ottawa, Ontario, K1N 6N5, Canada

Location
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2023

First Posted

March 15, 2023

Study Start

June 1, 2023

Primary Completion

June 1, 2024

Study Completion

September 1, 2024

Last Updated

May 12, 2023

Record last verified: 2023-05

Locations