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

NCT05770414 | Recruiting DMC

• 1 other identifier: H-02-23-8888
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Caregiver-child bond will be measured using the Maternal Postnatal Attachment Scale (MPAS)

  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 Outcomes (5)

• Caregivers' 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

• Caregivers' stress will be measured using the Parenting Stress Scale (PSS)

  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)

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

• Caregivers' emotion regulation will be assessed using three items from the Difficulties in Emotion Regulation Scale (DERS)

  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)

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

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Behavioral: Make the Connection® Online Program

Waitlist control group

NO INTERVENTION

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 BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Ottawa: lead

Study Sites (1)

University of Ottawa

Ottawa, Ontario, K1N 6N5, Canada

RECRUITING

Related Publications (1)

• Barriault S, Deneault AA, Kempe S, Madigan S, Lovegrove A, Dimitropoulos G, Riddell RP, Racine N. A randomized waitlist control trial of the Make the Connection(R) online program for caregivers of infants and young children: Study protocol. Digit Health. 2024 Jan 9;10:20552076231221053. doi: 10.1177/20552076231221053. eCollection 2024 Jan-Dec.

  PMID: 38205035 DERIVED

Central Study Contacts

Nicole Racine, PhD, C.Psych

CONTACT

403-992-7869; nracine2@uottawa.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 15, 2023
• Study Start: June 8, 2023
• Primary Completion: June 1, 2024
• Study Completion: September 1, 2024
• Last Updated: March 28, 2024

Record last verified: 2024-03

Locations

CA (1)