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

NCT04902404 | Completed

• 1 other identifier: REB21-0415
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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 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 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.

Study Arms (2)

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.

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.

Interventions

First Pathways Game 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.

First Pathways Group

Eligibility Criteria

• Age: 3 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead
• International Society of Psychiatric-Mental Health Nurses: collaborator

Study Sites (1)

Community Agencies

Calgary, Alberta, Canada

Location

Study Officials

• Jelena Komanchuk, BN

  University of Calgary

  PRINCIPAL INVESTIGATOR

• Nicole Letourneau, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

• Judy L Cameron, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in the Faculty of Nursing

Study Record Dates

• First Submitted: April 10, 2021
• First Posted: May 26, 2021
• Study Start: June 22, 2021
• Primary Completion: March 9, 2022
• Study Completion: March 9, 2022
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)