Internet-Based InterventionNCT04902404
Evaluation of the First Pathways Game on Parent-child Interactions and Development for Vulnerable Children
A study testing First Pathways Game in people with Internet-Based Intervention, run by University of Calgary at 1 site in Canada.
Trial summary
Children's brains develop quickly in the first three years of life and are particularly sensitive to their environment. Adverse experiences, such as exposure to abuse and neglect, can increase children's risk for behavioral, mental health (e.g., depression, anxiety), and developmental struggles. Read more about this study
- Who is it for?
- Ages 3 to 36 months
- Conditions the study is for
- Internet-Based Intervention
- What is being tested?
- First Pathways Game
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 22 Jun 2021to 9 Mar 2022
- 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 3 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child is aged 3-36 months
- Parent has a device (e.g. cellphone, laptop) to access the internet
- Parent has internet access
- Parent can provide informed written consent in English
Who cannot join
- Child has a neurodevelopmental (e.g., cerebral palsy) disorder or motor or language impairment
- Family plans to move out of Calgary and surrounding areas within two months of study enrollment
- Parent has received Working for Kids: Building Skills Training
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial to Evaluate the Effectiveness of the First Pathways Game on Parent-child Interaction Quality and Children's Development for Children Aged 3-36 Months Experiencing Adversity in Calgary
Children's brains develop quickly in the first three years of life and are particularly sensitive to their environment. Adverse experiences, such as exposure to abuse and neglect, can increase children's risk for behavioral, mental health (e.g., depression, anxiety), and developmental struggles. Fortunately, supportive, nurturing parents can help protect children from these poor health and developmental outcomes. In-person parenting programs have been shown to improve parents' interactions with their children. However, many parents struggle to access these programs due to competing life demands and accessibility barriers (e.g., lack of transportation and childcare). The First Pathways Game is a free, online tool that was created by an expert in brain development to provide parents with games and activities for playtime with their child, based on their child's age. The investigators plan to study the impact of the First Pathways Game on parent-child interactions and development of children aged 3-36 months. The investigators will recruit families in Calgary that are experiencing adversity, such as poverty and homelessness. Parent-child pairs will be randomly assigned to the (1) First Pathways group that is reminded to play the First Pathways Game daily for a month or (2) wait-list control group, to allow for comparisons. Before, immediately after, and 2 months after the month-long program, the investigators will collect information on parent-child interactions and children's development with reliable and valid tools to examine the effectiveness of the First Pathways Game. This free, online tool has the potential to empower parents in supporting their children's health and development and could be ideal for families experiencing vulnerability, due to its accessibility. If found effective, this tool could improve both short- and long-term health outcomes for children with experiences of adversity.
Read the detailed description
Background and Rationale: Exposure to early adverse childhood experiences (ACEs), such as abuse and neglect, increase children's risk for detrimental health (e.g., physical, mental, behavioral) and developmental (e.g., milestones, academic) consequences. Since children's brains develop rapidly within the first few years of life, they are remarkably sensitive to ACEs, yet positive parent-child interactions can buffer the impacts of early adversities. Although numerous, efficacious in-person parenting interventions are available, barriers (e.g., transportation, childcare) limit accessibility. Recent research has shown that families are interested in accessing parenting and child development information online, and over 80% of low-income families have internet access and internet-enabled devices. Furthermore, online interventions are of particular importance during the novel coronavirus (COVID-19) pandemic when limited in-person resources are available. The First Pathways Game (www.firstpathwaysgame.com) is a free online tool aimed at improving parent-child interactions and children's development by providing parents with age-appropriate, interactive activities. The First Pathways Game was developed by neuroscientist Dr. Judy Cameron to promote parent-child interactions and children's development by sharing neuroscience knowledge and age-appropriate game ideas for parents and children to play together. A pilot study of 16 low-income families in Pittsburgh showed improved parent-child interaction scores for children at the highest risk, offering evidence of promise as a feasible intervention.
Objective: The investigators will examine the effect of the First Pathways Game on parent-child interactions and children's developmental milestones for disadvantaged (e.g., low-income) families with children aged 3-36 months in Calgary, Alberta.
Methods: The investigators will conduct a multi-center, two-arm, parallel-group, superiority randomized controlled trial with a 1:1 allocation ratio. Parent-child pairs will be recruited from Calgary agencies that provide services for families facing adversity, such as families who have experienced domestic violence and low-income families. Data collection will be facilitated by REDCap with integrated computer-aided block randomization. Both groups will be assessed at baseline, and one and two months later with observational and parent-reported questionnaire measures. Participants will be randomized to the First Pathways group or wait-list control group after the baseline data assessment is complete. Parents in the First Pathways group will receive their choice of daily reminders (e.g., phone call, email, text message) to access the First Pathways website daily for the first month and their game utilization will be tracked by their device (phone, tablet, computer) for the two-month study duration. Parent-child pairs in the wait-list control group will receive access to the First Pathways website after the final two-month assessment.
- Conditions
- Internet-Based Intervention
- Being tested
- First Pathways Game
- Keywords
- randomized controlled trial, digital parenting intervention, parent-child interactions, children's developmental milestones, adverse childhood experiences, vulnerable population, infants/young children, health promotion, community-based research
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First Pathways GameOther
The First Pathways Game is a free, online parenting education program. Parents watch short videos (approximately 30 seconds) on the First Pathways Game website to receive neuroscience knowledge and ideas for age-appropriate game ideas to play with their child. The game ideas employ common household items, such as measuring cups and paper.
| Study group | Role | What they receive |
|---|---|---|
| First Pathways Group | Experimental | Parents in the First Pathways Game group will be instructed to log into the First Pathways website daily and play First Pathways games with their child. They will receive daily reminders for the first month after randomization but will not receive reminders for the second month. Receives: Other: First Pathways Game |
| Wait-list Control | No intervention | Parents in the wait-list control group will receive access to the First Pathways game after completing their final two-month study assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent-Child Interaction Quality
The observational Parent-Child Interaction Teaching Scale will be utilized to measure parent-child interaction quality. Parent-child interactions are assessed while parents teach their child a new skill, with 73 binary (yes, no) observational measures. The Parent-Child Interaction Teaching scale provides total scores for parent (i.e., sensitivity to cues, responsiveness to distress, social-emotional growth fostering, cognitive growth fostering) and child (i.e., clarity of cues, responsiveness to parent) behaviors. Parental scores range from 0-50, and child behaviors range from 0-23; high scores represent optimal parent-child interactions.
Measured: Parent-child interactions will be measured with the Parent-Child Interaction Teaching Scale at baseline and one and two months post randomization to assess change in parent-child interaction scores over time.
Parent-Child Interaction Quality
The Simple Interactions tool will be utilized as a second observational measure of parent-child interactions, and data from this research will inform the convergent validity between the Simple Interactions and Parent-Child Interaction Teaching Scale. Parent-child pairs are evaluated on three outcomes: (1) parent-child mutual social and emotional connection; (2) balanced back and forth interactions called reciprocity; and (3) parental willingness to offer appropriate challenges to their child to provide them with an opportunity to grow. Parent-child pairs can receive scores ranging from 100-500 for each outcome (i.e., connection, reciprocity, opportunity to grow), with a score of 500 indicating high optimal parent-child interactions. Additionally, an overall composite score is created by averaging the connection, reciprocity, and opportunity to grow scores.
Measured: Parent-child interactions will be measured with the Simple Interactions tool at baseline and one and two months post randomization to assess change in parent-child interaction scores over time.
Secondary outcomes (2)
Children's gross and fine motor, communication, personal-social, and problem-solving skills.
The Ages and Stages Questionnaires Third Edition will be utilized to measure children's gross and fine motor, communication, personal-social, and problem-solving skills. This parent-reported screening tool is comprised of 21 questionnaires for children aged 1-66 months. Each developmental domain (i.e., communication, gross motor, fine motor, problem-solving, personal-social) is comprised of six questions and scores range from 0-60; children who score below an age-determined threshold for each developmental domain are considered to have a developmental concern.
Measured: The Ages and Stages Questionnaire Third edition will be administered at baseline and one and two months post randomization to determine if children's gross motor, fine motor, communication, personal-social, and problem-solving skills change over time.
Children's social-emotional development
The parent-reported Ages and Stages Questionnaire Social-Emotional Second edition will be utilized to measure children's social-emotional development; this tool is employed for children aged 1-72 months and is comprised of 9 questionnaires. Score ranges differ per age group as the number of items varies between questionnaires. For example, the 6-month questionnaire includes 23 items and the 18-month questionnaire includes 31 items. Per item, scores range from 0-15, with lower scores indicative of more optimal social-emotional development. Children who score above an age-specific cut-off are considered to have a social-emotional developmental concern.
Measured: The Ages and Stages Questionnaire Social-Emotional Second Edition will be administered at baseline and one and two months post randomization to determine if children's social-emotional development changes over time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start22 Jun 2021
- Primary completion9 Mar 2022
- Study completion9 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Internet-Based InterventionStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- International Society of Psychiatric-Mental Health Nurses
- Responsible party
- Principal investigator, Nicole Letourneau, University of Calgary
- Investigators
- Jelena Komanchuk, BN, Principal investigator, University of CalgaryNicole Letourneau, PhD, Principal investigator, University of CalgaryJudy L Cameron, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04902404
- Sponsor's protocol ID
- REB21-0415
- Status last verified
- May 2024
- First submitted
- 10 Apr 2021
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate the Effectiveness of the First Pathways Game on Parent-child Interaction Quality and Children's Development for Children Aged 3-36 Months Experiencing Adversity in Calgary
- ClinicalTrials.gov ID
- NCT04902404
- Acronym / sponsor ID
- REB21-0415
- Conditions
- Internet-Based Intervention
- Keywords
- randomized controlled trial, digital parenting intervention, parent-child interactions, children's developmental milestones, adverse childhood experiences, vulnerable population, infants/young children, health promotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- International Society of Psychiatric-Mental Health Nurses
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- 9 Mar 2022 (actual)
- Study completion
- 9 Mar 2022 (actual)
- First posted
- 26 May 2021 (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.
Children's brains develop quickly in the first three years of life and are particularly sensitive to their environment. Adverse experiences, such as exposure to abuse and neglect, can increase children's risk for behavioral, mental health (e.g., depression, anxiety), and developmental struggles. Fortunately, supportive, nurturing parents can help protect children from these poor health and developmental outcomes. In-person parenting programs have been shown to improve parents' interactions with their children. However, many parents struggle to access these programs due to competing life demands and accessibility barriers (e.g., lack of transportation and childcare). The First Pathways Game is a free, online tool that was created by an expert in brain development to provide parents with games and activities for playtime with their child, based on their child's age. The investigators plan to study the impact of the First Pathways Game on parent-child interactions and development of children aged 3-36 months. The investigators will recruit families in Calgary that are experiencing adversity, such as poverty and homelessness. Parent-child pairs will be randomly assigned to the (1) First Pathways group that is reminded to play the First Pathways Game daily for a month or (2) wait-list control group, to allow for comparisons. Before, immediately after, and 2 months after the month-long program, the investigators will collect information on parent-child interactions and children's development with reliable and valid tools to examine the effectiveness of the First Pathways Game. This free, online tool has the potential to empower parents in supporting their children's health and development and could be ideal for families experiencing vulnerability, due to its accessibility. If found effective, this tool could improve both short- and long-term health outcomes for children with experiences of adversity.
Detailed description
Background and Rationale: Exposure to early adverse childhood experiences (ACEs), such as abuse and neglect, increase children's risk for detrimental health (e.g., physical, mental, behavioral) and developmental (e.g., milestones, academic) consequences. Since children's brains develop rapidly within the first few years of life, they are remarkably sensitive to ACEs, yet positive parent-child interactions can buffer the impacts of early adversities. Although numerous, efficacious in-person parenting interventions are available, barriers (e.g., transportation, childcare) limit accessibility. Recent research has shown that families are interested in accessing parenting and child development information online, and over 80% of low-income families have internet access and internet-enabled devices. Furthermore, online interventions are of particular importance during the novel coronavirus (COVID-19) pandemic when limited in-person resources are available. The First Pathways Game (www.firstpathwaysgame.com) is a free online tool aimed at improving parent-child interactions and children's development by providing parents with age-appropriate, interactive activities. The First Pathways Game was developed by neuroscientist Dr. Judy Cameron to promote parent-child interactions and children's development by sharing neuroscience knowledge and age-appropriate game ideas for parents and children to play together. A pilot study of 16 low-income families in Pittsburgh showed improved parent-child interaction scores for children at the highest risk, offering evidence of promise as a feasible intervention.
Objective: The investigators will examine the effect of the First Pathways Game on parent-child interactions and children's developmental milestones for disadvantaged (e.g., low-income) families with children aged 3-36 months in Calgary, Alberta.
Methods: The investigators will conduct a multi-center, two-arm, parallel-group, superiority randomized controlled trial with a 1:1 allocation ratio. Parent-child pairs will be recruited from Calgary agencies that provide services for families facing adversity, such as families who have experienced domestic violence and low-income families. Data collection will be facilitated by REDCap with integrated computer-aided block randomization. Both groups will be assessed at baseline, and one and two months later with observational and parent-reported questionnaire measures. Participants will be randomized to the First Pathways group or wait-list control group after the baseline data assessment is complete. Parents in the First Pathways group will receive their choice of daily reminders (e.g., phone call, email, text message) to access the First Pathways website daily for the first month and their game utilization will be tracked by their device (phone, tablet, computer) for the two-month study duration. Parent-child pairs in the wait-list control group will receive access to the First Pathways website after the final two-month assessment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First Pathways Group | Experimental | Other: First Pathways GameParents in the First Pathways Game group will be instructed to log into the First Pathways website daily and play First Pathways games with their child. They will receive daily reminders for the first month after randomization but will not receive reminders for the second month. |
| Wait-list Control | No intervention | –Parents in the wait-list control group will receive access to the First Pathways game after completing their final two-month study assessment. |
Who may qualify
- Ages
- 3 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Child is aged 3-36 months
- Parent has a device (e.g. cellphone, laptop) to access the internet
- Parent has internet access
- Parent can provide informed written consent in English
Key exclusion criteria (3 listed)
- Child has a neurodevelopmental (e.g., cerebral palsy) disorder or motor or language impairment
- Family plans to move out of Calgary and surrounding areas within two months of study enrollment
- Parent has received Working for Kids: Building Skills Training
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 |
|---|---|---|
| First Pathways GameThe First Pathways Game is a free, online parenting education program. Parents watch short videos (approximately 30 seconds) on the First Pathways Game website to receive neuroscience knowledge and ideas for age-appropriate game ideas to play with their child. The game ideas employ common household items, such as measuring cups and paper. | Other | First Pathways Group |
Primary outcome
Parent-Child Interaction Quality
Time frame: Parent-child interactions will be measured with the Parent-Child Interaction Teaching Scale at baseline and one and two months post randomization to assess change in parent-child interaction scores over time.
The observational Parent-Child Interaction Teaching Scale will be utilized to measure parent-child interaction quality. Parent-child interactions are assessed while parents teach their child a new skill, with 73 binary (yes, no) observational measures. The Parent-Child Interaction Teaching scale provides total scores for parent (i.e., sensitivity to cues, responsiveness to distress, social-emotional growth fostering, cognitive growth fostering) and child (i.e., clarity of cues, responsiveness to parent) behaviors. Parental scores range from 0-50, and child behaviors range from 0-23; high scores represent optimal parent-child interactions.
Parent-Child Interaction Quality
Time frame: Parent-child interactions will be measured with the Simple Interactions tool at baseline and one and two months post randomization to assess change in parent-child interaction scores over time.
The Simple Interactions tool will be utilized as a second observational measure of parent-child interactions, and data from this research will inform the convergent validity between the Simple Interactions and Parent-Child Interaction Teaching Scale. Parent-child pairs are evaluated on three outcomes: (1) parent-child mutual social and emotional connection; (2) balanced back and forth interactions called reciprocity; and (3) parental willingness to offer appropriate challenges to their child to provide them with an opportunity to grow. Parent-child pairs can receive scores ranging from 100-500 for each outcome (i.e., connection, reciprocity, opportunity to grow), with a score of 500 indicating high optimal parent-child interactions. Additionally, an overall composite score is created by averaging the connection, reciprocity, and opportunity to grow scores.
2 secondary outcomes
Children's gross and fine motor, communication, personal-social, and problem-solving skills.
Time frame: The Ages and Stages Questionnaire Third edition will be administered at baseline and one and two months post randomization to determine if children's gross motor, fine motor, communication, personal-social, and problem-solving skills change over time.
Children's social-emotional development
Time frame: The Ages and Stages Questionnaire Social-Emotional Second Edition will be administered at baseline and one and two months post randomization to determine if children's social-emotional development changes over time.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Individual participant dataSharing planned: No
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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.
Jelena Komanchuk, BN principal investigator
University of Calgary
Nicole Letourneau, PhD principal investigator
University of Calgary
Judy L Cameron, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing First Pathways Game in people with Internet-Based Intervention, run by University of Calgary 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 3 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: finished, as of the sponsor's last update on 10 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Interaction Quality (time frame: Parent-child interactions will be measured with the Parent-Child Interaction Teaching Scale at baseline and one and two months post randomization to assess change in parent-child interaction scores over time.). The study lists 2 primary outcomes in all. 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 10 May 2024.