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

University of Ottawa

Status: Enrolling

Conditions: Parent-Child Relations

Treatments: Behavioral: Make the Connection® Online Program

Study type: Interventional

Funder types: Other

Identifiers

NCT05770414

H-02-23-8888

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Intervention group

Experimental group

Description:

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

Treatment:

Behavioral: Make the Connection® Online Program

Waitlist control group

No Intervention group

Description:

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.