Parent-Child RelationsNCT05770414
Evaluating an Online Parenting Intervention for Caregivers of Infants and Young Children
A study testing Make the Connection® Online Program in people with Parent-Child Relations, run by University of Ottawa at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parent-Child Relations
- What is being tested?
- Make the Connection® Online Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 8 Jun 2023to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of Ottawa
Ottawa, Ontario, K1N 6N5
Nicole Racine, PhD, C.Psych, 403-992-7869, nracine2@uottawa.ca
About this study
Official title: Can We Still Make the Connection? Evaluating an Online Parenting Intervention for Caregivers of Infants and Young Children
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?
Read more
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
- Being tested
- Make the Connection® Online Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Make the Connection® Online ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants assigned to this group will receive the MTC online program after completing the pre-intervention questionnaire. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
The PSOC has 14-items and measures a caregiver'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. A higher score indicates a higher parenting sense of competency. There are no average scores or 'cut-off's' for this tool.
Measured: 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)
The PSS is an 18-item questionnaire that assesses both positive and negative perceptions and feelings associated with being a parent. The PSS has been widely used and has been found to have strong psychometric properties. Parental stress scores range from 18 to 90, with lower scores indicating lower levels of parental stress. There is no cut-off score.
Measured: 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)
The CES-D contains 20 items and requires individuals to rate how often they experienced symptoms of depression over the past week. This scale has demonstrated good reliability and validity. Possible range of scores is 0 to 60, with higher scores indicating the presence of more symptomatology. A score of 16 or greater is considered a risk for clinical depression.
Measured: 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)
Measured: 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)
Measured: Change from pre-intervention scores at baseline and post-intervention scores at week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start8 Jun 2023
- Primary completionJun 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parent-Child RelationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770414
- Sponsor's protocol ID
- H-02-23-8888
- Status last verified
- Mar 2024
- First submitted
- 21 Feb 2023
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38205035
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can We Still Make the Connection? Evaluating an Online Parenting Intervention for Caregivers of Infants and Young Children
- ClinicalTrials.gov ID
- NCT05770414
- Acronym / sponsor ID
- H-02-23-8888
- Conditions
- Parent-Child Relations
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 15 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Make the Connection® Online ProgramParticipants assigned to this group will receive the MTC online program after completing the pre-intervention questionnaire. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Make the Connection® Online ProgramMake 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. | Behavioural | Intervention group |
Primary outcome
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
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.
5 secondary outcomes
Caregivers' self-efficacy will be measured using the Parent Sense of Competence Questionnaire (PSOC)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Change from pre-intervention scores at baseline and post-intervention scores at week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Derived from this study: PubMed 38205035Barriault 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Make the Connection® Online Program in people with Parent-Child Relations, run by University of Ottawa at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicole Racine, PhD, C.Psych (403-992-7869, nracine2@uottawa.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05770414, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.