Clinical trial NCT04902404: Evaluation of the First Pathways Game on Parent-child Interactions and Development for Vulnerable Children
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
community-based research
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: International Society of Psychiatric-Mental Health Nurses
First posted: 2021-05-26
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Child is aged 3-36 months
2. Parent has a device (e.g. cellphone, laptop) to access the internet
3. Parent has internet access
4. Parent can provide informed written consent in English

Exclusion Criteria:

1. Child has a neurodevelopmental (e.g., cerebral palsy) disorder or motor or language impairment
2. Family plans to move out of Calgary and surrounding areas within two months of study enrollment
3. Parent has received Working for Kids: Building Skills Training

Primary outcomes:
measure: Parent-Child Interaction Quality
timeFrame: 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.
measure: Parent-Child Interaction Quality
timeFrame: 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:
measure: Children's gross and fine motor, communication, personal-social, and problem-solving skills.
timeFrame: 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.
measure: Children's social-emotional development
timeFrame: 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.
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Community Agencies
state: Alberta
Study officials:
affiliation: University of Calgary
name: Jelena Komanchuk, BN
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: Nicole Letourneau, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: Judy L Cameron, PhD
role: PRINCIPAL_INVESTIGATOR
References: