Evaluating an Online Parenting Intervention in Parents At-Risk for Parent-Child Relationship Difficulties

Sponsor
University of Ottawa (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05770414
Collaborator
(none)
200
1
2
13.6
14.7

Study Details

Study Description

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 parents who are at-risk for parent-child relationship difficulties. The main questions it aims to answer are:

  • Does the MTC online program result in improvements in parent-child bond, parent self-efficacy, parental stress, and parental depression as compared to a waitlist control among parents at-risk for parent-child relationship difficulties?

  • What are some of the barriers, facilitators, perceived benefits and risks to participating in the MTC online program from the perspective of parents?

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 parent-child bond, parent self-efficacy, parental stress, and parental depression.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Make the Connection® Online Program
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Can We Still Make the Connection? Evaluating an Online Parenting Intervention for Parents of Infants and Young Children At-Risk for Parent-Child Relationship Difficulties
Anticipated Study Start Date :
Mar 15, 2023
Anticipated Primary Completion Date :
Mar 15, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

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 parents 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 parents 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.

Outcome Measures

Primary Outcome Measures

  1. Parent-child bond will be measured using the Maternal Postnatal Attachment Scale (MPAS) [Change from pre-intervention scores at baseline and post-intervention scores at week 8]

    The MPAS is a 19-item questionnaire that assesses parents' 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.

Secondary Outcome Measures

  1. Parent 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]

    The PSOC has 14-items and measures a parent'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.

  2. Parental stress will be measured using the Parenting Stress Scale (PSS) [Change from pre-intervention scores at baseline and post-intervention scores at week 8]

  3. Parental 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • parents with children between the ages of 0-3 years old

  • parents are primarily responsible for the children

  • parents are at-risk for parent-child relationship difficulties (must endorse two of the following criteria: being a first-time caregiver, socially isolated, low education, caregiving alone, lack of confidence or self-efficacy, at risk for poor infant sensitivity, or at-risk for depression)

Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Ottawa Ottawa Ontario Canada K1N 6N5

Sponsors and Collaborators

  • University of Ottawa

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Ottawa
ClinicalTrials.gov Identifier:
NCT05770414
Other Study ID Numbers:
  • H-02-23-8888-1
First Posted:
Mar 15, 2023
Last Update Posted:
Mar 15, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 15, 2023