Evaluating an Online Parenting Intervention for Caregivers of Infants and Young Children

March 26, 2024 updated by: University of Ottawa

Can We Still Make the Connection? Evaluating an Online Parenting Intervention for Caregivers 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 caregivers of infants and young children. The main questions it aims to answer are:

  • Does the MTC online program result in changes in the child-caregiver relationship, caregiver self-competence, caregiver stress, caregiver depression, as well as caregiver and child emotion regulation, as compared to a waitlist control?
  • Are caregivers who experience psychosocial risks (e.g., elevated depression scores, social isolation) deriving similar benefits in the child-caregiver relationship, caregiver self-competence, caregiver stress, caregiver depression, as well as caregiver and child emotion regulation as caregivers who are not?
  • What are some of the barriers, facilitators, perceived benefits, and risks to participating in the MTC online program from the perspective of caregivers?

Participants will be randomly placed into either the intervention group or the waitlist control group. Both groups will be asked to complete a pre-intervention questionnaire, the intervention group will be invited to complete the 8-week MTC online program consisting of a weekly 15-minute module, and both groups will lastly be asked to complete a post-intervention questionnaire.

Researchers will compare the intervention group and the waitlist control group to see if the MTC online program results in improved caregiver-child bond, caregiver self-efficacy, caregiver stress, and caregiver depression.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1N 6N5
        • Recruiting
        • University of Ottawa
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • caregivers with children between the ages of 0-3 years old
  • caregivers are primarily responsible for the children
  • caregivers are over 18 years of age
  • caregivers are able to complete the questionnaires and understand the program content in English

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Participants assigned to this group will receive the MTC online program after completing the pre-intervention questionnaire.
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 caregivers 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 caregivers 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.
No Intervention: Waitlist control group
Participants assigned to this group will not receive the MTC online program during the study period. At the end of the 8 weeks and after the post-questionnaire is completed, they will have the option to receive the MTC online program if they wish.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caregiver-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 caregivers' 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. The minimum score is 19 while the maximum score is 95. Lower scores indicate more problematic responses and there is no cut off points for problematic or concerning relationships.
Change from pre-intervention scores at baseline and post-intervention scores at week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caregivers' emotion regulation will be assessed using three items from the Difficulties in Emotion Regulation Scale (DERS)
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
Infant emotion regulation will be assessed using two items from the Ages & stages questionnaire: Social-Emotional, Second Edition (ASQ-SE)
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
Caregivers' 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 caregiver'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. A higher score indicates a higher parenting sense of competency. There are no average scores or 'cut-off's' for this tool.
Change from pre-intervention scores at baseline and post-intervention scores at week 8
Caregivers' 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
The PSS is an 18-item questionnaire that assesses both positive and negative perceptions and feelings associated with being a parent. The PSS has been widely used and has been found to have strong psychometric properties. Parental stress scores range from 18 to 90, with lower scores indicating lower levels of parental stress. There is no cut-off score.
Change from pre-intervention scores at baseline and post-intervention scores at week 8
Caregivers' 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
The CES-D contains 20 items and requires individuals to rate how often they experienced symptoms of depression over the past week. This scale has demonstrated good reliability and validity. Possible range of scores is 0 to 60, with higher scores indicating the presence of more symptomatology. A score of 16 or greater is considered a risk for clinical depression.
Change from pre-intervention scores at baseline and post-intervention scores at week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ottawa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

February 21, 2023

First Submitted That Met QC Criteria

March 3, 2023

First Posted (Actual)

March 15, 2023

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • H-02-23-8888

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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