Clinical trial NCT05770414: Evaluating an Online Parenting Intervention for Caregivers of Infants and Young Children
Official title: Can We Still Make the Connection? Evaluating an Online Parenting Intervention for Caregivers of Infants and Young Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parent-Child Relations
Lead sponsor: University of Ottawa
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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:

-

Primary outcomes:
measure: Caregiver-child bond will be measured using the Maternal Postnatal Attachment Scale (MPAS)
timeFrame: Change from pre-intervention scores at baseline and post-intervention scores at week 8
Secondary outcomes:
measure: Caregivers' self-efficacy will be measured using the Parent Sense of Competence Questionnaire (PSOC)
timeFrame: Change from pre-intervention scores at baseline and post-intervention scores at week 8
measure: Caregivers' stress will be measured using the Parenting Stress Scale (PSS)
timeFrame: Change from pre-intervention scores at baseline and post-intervention scores at week 8
measure: Caregivers' depression will be measured using the Centre for Epidemiological Studies Depression Scale (CES-D)
timeFrame: Change from pre-intervention scores at baseline and post-intervention scores at week 8
measure: Caregivers' emotion regulation will be assessed using three items from the Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Change from pre-intervention scores at baseline and post-intervention scores at week 8
measure: Infant emotion regulation will be assessed using two items from the Ages & stages questionnaire: Social-Emotional, Second Edition (ASQ-SE)
timeFrame: Change from pre-intervention scores at baseline and post-intervention scores at week 8
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa
state: Ontario
Study officials:
References: