Parent-Child RelationsNCT05770427
Evaluating an Online Parenting Intervention in a Community-Based Sample of Parents
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 a community-based sample of parents not at-risk for parenting difficulties. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- 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
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- parents with children between the ages of 0-3 years old
- parents are primarily responsible for the children
Who cannot join
- parents are at-risk for parent-child relationship difficulties (i.e., 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can We Still Make the Connection? Evaluating an Online Parenting Intervention in a Community-Based Sample of Parents 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 a community-based sample of parents not at-risk for parenting 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 among parents who are not 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 asked to complete a pre-intervention questionnaire, will be invited to complete the 8-week MTC online program consisting of a weekly 15-minute module, and will lastly be asked to complete a post-intervention questionnaire.
- 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 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Behavioral: Make the Connection® Online Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent-child bond will be measured using the Maternal Postnatal Attachment Scale (MPAS)
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.
Measured: Change from pre-intervention scores at baseline and post-intervention scores at week 8
Secondary outcomes (3)
Parent self-efficacy will be measured using the Parent Sense of Competence Questionnaire (PSOC)
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.
Measured: Change from pre-intervention scores at baseline and post-intervention scores at week 8
Parental stress will be measured using the Parenting Stress Scale (PSS)
Measured: Change from pre-intervention scores at baseline and post-intervention scores at week 8
Parental depression will be measured using the Centre for Epidemiological Studies Depression Scale (CES-D)
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 startJun 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionSep 2024 (estimated)
Why it stopped: Change in study design (see NCT05770414 for current and active trial).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770427
- Sponsor's protocol ID
- H-02-23-8888-2
- Status last verified
- May 2023
- First submitted
- 21 Feb 2023
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. 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 in a Community-Based Sample of Parents of Infants and Young Children
- ClinicalTrials.gov ID
- NCT05770427
- Acronym / sponsor ID
- H-02-23-8888-2
- Conditions
- Parent-Child Relations
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in study design (see NCT05770414 for current and active trial).
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- 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 a community-based sample of parents not at-risk for parenting 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 among parents who are not 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 asked to complete a pre-intervention questionnaire, will be invited to complete the 8-week MTC online program consisting of a weekly 15-minute module, and will lastly be asked to complete a post-intervention questionnaire.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Make the Connection® Online Program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- parents with children between the ages of 0-3 years old
- parents are primarily responsible for the children
Key exclusion criteria (1 listed)
- parents are at-risk for parent-child relationship difficulties (i.e., 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)
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 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. | Behavioural | Intervention group |
Primary outcome
Parent-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 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.
3 secondary outcomes
Parent 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
Parental 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
Parental 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
Related trials for Parent-Child Relations
Active, not recruiting
A Mobile App to Improve 24-Hour Movement Guideline Adherence in Preschoolers
Healthy, 24-Hour Movement Guidelines
Recruiting
Online Feeding Education for Fathers of Children With Feeding Problems
Feeding Problems, Parent Training
Active, not recruiting
Parent-Educator Action Response
Attention Deficit and Disruptive Behavior Disorders
Not yet recruiting
Hybrid Pilot of Personalized Parent-Child Interaction Therapy
Disruptive Behaviors
Active, not recruiting
Adapting the Sensory Environment to Reduce Stress in Children With Autism During Dental Visits
Autism, Autism Disorders and Maternal Stress
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.
The record lists no contact. Use the official record to reach the sponsor.
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 2 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: withdrawn, as of the sponsor's last update on 12 May 2023. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent-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?
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 12 May 2023.