Clinical trial NCT04925258: Supporting Parent and Child Engagement
Official title: Supporting Parent and Child Engagement - SPACE Parenting Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress, Psychological
Parenting
Covid19
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2021-06-14
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will recruit a group of parents and primary caregivers (e.g., mothers, fathers, adoptive parents, grandparents) who report elevated levels of parenting stress (above the 50th percentile of population norms on the Parenting Stress Index), and are the legal guardians of a child in the 3- to 4-year-old age range. Those parents will be randomly assigned to one treatment condition or the control condition. Parents in the treatment condition will participate in an 8-week parenting program that includes a combination of activities, parenting training, as well as drop-in sessions with a trained psychology student (MA-level or higher) or psychologist. The control group will receive services-as-usual (referral list for online and telehealth parenting and family mental health services).
Primary purpose: TREATMENT

Brief summary: The COVID-19 pandemic and measures aimed at reducing the spread of the virus have created unique challenges and stresses for Canadian families. Balancing work, family, and daily life has become extremely difficult for many families. Economic uncertainty is widespread as many parents are dealing with increased demands such as working from home, running the household, and homeschooling and caring for their children without the support of their social networks. Recent findings from a study on the impact of the COVID-19 pandemic on young families conducted by our lab found that parents reported increased levels of stress, difficulties in following through with their parenting duties, and challenges managing their children's behaviour. Accessible programs are urgently needed to help parents cultivate supportive family relationships during and in recovery from the COVID-19 pandemic as physical distancing and public health requirements have further decreased the accessibility of existing programming. The proposed research aims to test the relative value of multiple light-touch parenting supports (developed through the REB-approved BRIDGE program, NCT04347707 and NCT04639557) in a 2-arm randomized control trial including behaviour management and emotion-focused strategies delivered through psychoeducational parenting videos, structured family activities, and an online parenting support group. The investigators plan to evaluate the efficacy of this program at reducing parenting stress (primary outcome) and promoting family well-being (secondary outcomes).

Detailed description: Supportive parent-child relationships are increasingly understood to be the single most important predictor of resilient child development because they shape children's ability to build relationships and navigate the world around them. The emergence of emotion regulation skills during the preschool years serves as a key step in adaptive trajectories through which children learn to communicate their needs, engage in prosocial behaviour, and prepare for learning opportunities at school and beyond. Unfortunately, the COVID-19 pandemic has placed striking pressure on parents' capacities to engage in consistently supportive interactions due to factors such as limited childcare, financial strain, and poor mental health, which each present risks for child development.

The team of investigators designed the SPACE Program (Supporting Parent And Child Emotional well-being) to directly and immediately respond to family needs, with the potential for long-term impacts through its highly scalable approach. SPACE brings together best practices in emotion-focused parenting in a format guided by our Parent Advisory Board and over 1000 families who described their unmet needs in our rapid-response Parenting During the Pandemic survey. SPACE includes the provision of materials (i.e., psychoeducational videos and hands-on emotion-focused activities) alongside a virtual and interactive, facilitator-led parenting group to re-enforce skill acquisition and provide social support. The investigators' mixed-methods assessments are designed to understand the impacts of SPACE across multiple indicators of family function. The long-term goal is to create an accessible evidence-based online parenting program to promote child emotional development and well-being.

There are three objectives for the SPACE parenting project:

1. Assess the benefits of the novel SPACE program on parenting stress and parenting quality compared to services as usual (SAU): free provincial parenting resource guides and parenting sheets.
2. Determine the extent to which the SPACE program impacts child emotion-regulation development and if this relationship is mediated by parents' emotional and behavioural change.
3. Identify baseline factors linked to differential efficacy of SPACE. Hypothesis: SPACE will have higher efficacy for improving outcomes for children who a) identify as girls, b) exhibit higher cognitive performance, and c) exhibit greater cardiac flexibility.

Eligibility criteria: Inclusion Criteria:

* Manitoba residence, parenting status (i.e., legal guardianship)
* Parents 18 years old or older
* Child/children's age group (ages 3-4)
* Elevated Parenting Stress Index- Short form (PSI-SF) scores (falling into the upper 50% range)
* English proficiency
* Access to a device with a camera (Smart phone, tablet, computer)

Exclusion Criteria:

* Resides outside Manitoba
* Parents under 18 years old
* Parents do have not legal guardianship of child
* Child \<3 years or \>4 years
* Parenting Stress Index- Short form (PSI-SF) score in bottom 50% range
* Not proficient in English
* No access to a device with a camera (Smart phone, tablet, computer)

Primary outcomes:
measure: Change in parenting stress
timeFrame: : Time 1 prior to the beginning SPACE Program to ensure participants meet the inclusion criteria (upper 50th percentile on the PSI) and at Time 2 once again after the program is complete (approx. 8 weeks after Time 1), and Time 3 (approx. 3 months after
Secondary outcomes:
measure: Change in child mental health and behaviour
timeFrame: Time 1 prior to the beginning SPACE Program and at Time 2 once again after the program is complete (approx. 8 weeks after Time 1), and Time 3 (approx.. 3 months after Time 2).
measure: Change in child behaviour
timeFrame: Time 1 prior to beginning SPACE Program and at Time 2 once again after the program is complete (approx. 8 weeks after Time 1), and Time 3 (approx. 3 months after Time 2).
measure: Change in parent depressive symptoms
timeFrame: Time 1 prior to the beginning SPACE Program and at Time 2 once again after the program is complete (approx. 8 weeks after Time 1), and Time 3 (approx.. 3 months after Time 2).
measure: Change in parent anxiety symptoms
timeFrame: Time 1 prior to the beginning SPACE Program and at Time 2 once again after the program is complete (approx. 8 weeks after Time 1), and Time 3 (approx.. 3 months after Time 2).
measure: Change in parent anger symptoms
timeFrame: Time 1 prior to the beginning SPACE Program and at Time 2 once again after the program is complete (approx. 8 weeks after Time 1), and Time 3 (approx.. 3 months after Time 2).
measure: Change in emotion-focused parenting practices
timeFrame: Time 1 prior to the beginning SPACE Program and at Time 2 once again after the program is complete (approx. 8 weeks after Time 1), and Time 3 (approx.. 3 months after Time 2)
measure: Change in parenting practices
timeFrame: Time 1: prior to the beginning SPACE Program and at Time 2 once again after the program is complete (approx. 8 weeks after Time 1), and Time 3 (approx. 3 months after Time 2).
measure: Change in mindful parenting practices intervention
timeFrame: Time 1 prior to the beginning SPACE Program and at Time 2 once again after the program is complete (approx. 8 weeks after Time 1), and Time 3 (approx.. 3 months after Time 2).
measure: Changes in perceived parental/caregiver resilience from pre-intervention to post-intervention
timeFrame: Time 1 prior to the beginning SPACE Program and at Time 2 once again after the program is complete (approx. 8 weeks after Time 1), and Time 3 (approx.. 3 months after Time 2).
measure: Changes in parent/child screen time pre and post intervention
timeFrame: Time 1 prior to the beginning SPACE Program and at Time 2 once again after the program is complete (approx. 8 weeks after Time 1), and Time 3 (approx.. 3 months after Time 2).
measure: Changes in parental/caregiver spanking practices from pre to post intervention
timeFrame: Time 1 prior to the beginning SPACE Program and at Time 2 once again after the program is complete (approx. 8 weeks after Time 1), and Time 3 (approx.. 3 months after Time 2).
measure: Changes in family resources measured from pre to post intervention
timeFrame: Time 1 prior to the beginning SPACE Program and at Time 2 once again after the program is complete (approx. 8 weeks after Time 1), and Time 3 (approx.. 3 months after Time 2).
measure: Changes in recent stressful events from pre to post intervention
timeFrame: Time period: Time 1 prior to the beginning SPACE Program and at Time 2 once again after the program is complete (approx. 8 weeks after Time 1), and Time 3 (approx.. 3 months after Time 2).
Other outcomes:
measure: Change in child cognitive function
timeFrame: Time 1 prior to the beginning SPACE Program and at Time 2 once again after the program is complete (approx. 8 weeks after Time 1).
measure: Change in child cardiac flexibility
timeFrame: Time 1 prior to the beginning SPACE Program and at Time 2 once again after the program is complete (approx. 8 weeks after Time 1).
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Leslie E Roos, PhD
role: PRINCIPAL_INVESTIGATOR
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