Recruiting

Observational Study

Sponsor:

University of Ottawa

Code:

NCT05770414

Conditions

Parent-Child Relations

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Make the Connection® Online Program

Study Details

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 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.

Conditions

Parent-Child Relations

Study ID

NCT05770414

Start date

Jun 8, 2023

Status verified date

Mar, 2024

Completion date

Sep, 2024

Anticipated

Primary completion date

Jun, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention group

Participants assigned to this group will receive the MTC online program after completing the pre-intervention questionnaire.

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.

Interventions

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Nicole Racine, PhD, C.Psych

403-992-7869nracine2@uottawa.ca

Locations

University of Ottawa

Recruiting

Ottawa, Ontario, Canada, K1N 6N5

Contacts

Nicole Racine, PhD, C.Psych

403-992-7869nracine2@uottawa.ca

More Information

Sponsor

University of Ottawa

Last update posted

Mar 28, 2024

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Ottawa on 2024-03-28.