Evaluation of the First Pathways Game on Parent-child Interactions and Development for Vulnerable Children

NCT ID: NCT04902404

Last Updated: 2024-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-22
• Study Completion Date: 2022-03-09

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.

Conditions

Internet-Based Intervention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

First Pathways Group

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.

Group Type: EXPERIMENTAL

First Pathways Game

Intervention Type: OTHER

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.

Wait-list Control

Parents in the wait-list control group will receive access to the First Pathways game after completing their final two-month study assessment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

First Pathways Game

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 36 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

International Society of Psychiatric-Mental Health Nurses

UNKNOWN

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Nicole Letourneau

Professor in the Faculty of Nursing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jelena Komanchuk, BN

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Nicole Letourneau, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Judy L Cameron, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

Community Agencies

Calgary, Alberta, Canada

Countries

Canada

Other Identifiers

REB21-0415

Identifier Type: -

Identifier Source: org_study_id