Supporting Parent and Child Engagement

Study Overview
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Brief Summary
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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
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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: 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. 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. 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.

Official Title
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Supporting Parent and Child Engagement - SPACE Parenting Program

Conditions
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Stress, Psychological, Parenting, Covid19

Intervention / Treatment
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* Behavioral: SPACE Parenting Program


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Services-as-usual<br>Services-as-usual (referral list for online and telehealth parenting and family mental health services). | |
| Experimental: SPACE Parenting Program<br>The experimental groups of Manitoba-based parent-child dyads (children ages 3-4 years old) include: 1. Weekly parenting materials, including online videos and mailed out parenting activities, that were developed for the Building Regulation in Dual Generations (BRIDGE) Therapy program. Also included are weekly drop-in group sessions with other parents facilitated by trained MA-level or higher psychology students or psychologists. | Behavioral: SPACE Parenting Program<br>* The program involves a two-arm randomized trial of differing parenting interventions which include: a service as usual (SAU) cohort, in which parents are provided with local and online parenting and family mental health resources; An intervention group called SPACE that includes weekly parenting materials (i.e., two online  10-minute videos, ten parent-child activities that were developed for the Building Regulation in Dual Generations (BRIDGE) Therapy program (NCT04347707 and NCT04639557) intervention group. Additionally, this group will receive weekly drop-in sessions with a facilitator-led (trained MA-level or higher psychology student or psychologist) interactive parenting group to re-enforce concepts and provide social support.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in parenting stress | The Parenting Stress Index - Short Form (PSI) is a 36-item self-report measure completed by parents to measure stress level within the context of parenting. Participants respond to items on a 5-point Likert scale. Responses to each item in a sub-category are totaled to calculate three subcategory scores, which are summed to represent a total parenting stress score. Higher scores indicate higher levels of parenting stress. Normal scores fall within the 15th to 85th percentile, and scores above the 85th percentile represent clinically elevated levels of stress. | : 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in child mental health and behaviour | Child behaviour from pre-intervention to post-intervention: Strengths and Difficulties Questionnaire (SDQ). A 25-item instrument developed to detect psychosocial problems in children aged 3-16 years. A value is given to each selection of not true, somewhat true, and certainly true. It measures five factors: emotional problems, conduct problems, hyperactivity/inattention problems, peer problems, and prosocial behaviour. All subscales include five items and range from 0-10. A total score can be summed from the first four factors; the total score ranges from 0-40, with higher scores indicating greater difficulties. Scores on the fifth factor of prosocial behaviour range from 0-10, with a lower score on this scale being less favourable. | 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). | 
| Change in child behaviour | The Parent Daily Report will be used to assess parent-reported child behaviors in past 24 hours. This scale assess child behaviour and degree of parental stress through 12-items. These items are reported on a 3-point Likert scale from did not occur (0) to occurred and stressful (2). Higher scores on an item indicate more negative child behaviours and more stressful experiences. | 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). | 
| Change in parent depressive symptoms | The Patient Health Questionnaire - 9 (PHQ-9) is a self-administered diagnostic instrument used to assess symptoms of major depressive disorder. The measure uses a 4-point Likert scale to assess the frequency of symptoms ranging from not at all to nearly every day. A total score ranges from 0 to 27, with higher scores indicating greater depressive symptoms. This measure will be completed by participants weekly throughout the intervention. | 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). | 
| Change in parent anxiety symptoms | Generalized Anxiety Disorder - 7 item scale (GAD-7) is a brief self-report measure to screen for generalized anxiety disorder. Scores range from 0-21, with higher scores indicating more severe anxiety. | 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). | 
| Change in parent anger symptoms | The PROMIS Emotional Distress - Anger - Short-Form is a brief self-report measure used to assess the domain of anger. The items are measured on a 5-point Likert scale from never (1) to always (5). Total scores range from 5 to 25, with higher scores indicating more severe anger. | 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). | 
| Change in emotion-focused parenting practices | The Parenting Scale (PS) is a self-report measure of parenting style. The scale uses 30 items to assess various aspects of parenting/caregiving on a 7-point Likert scale. Scores are measured on a scale of 1-7 on each item, with 7 being less effective measures. The scale produces three subscale scores of Laxness (5-items), Overreactivity (5-items), and Verbosity (3-items), as well as a total score that includes all items. Scores are calculated by summing the items and dividing by the number of items to create a mean score; for example, the total score ranges from 1-7. Higher scores represent less effective parenting. | 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) | 
| Change in parenting practices | The Parenting Young Children (PARYC) scale is a self-report measure containing 21 questions designed to address parenting behaviors relevant to caring for young children. The scale includes three subscales: Supporting Positive Behavior, Setting Limits, and Proactive Parenting. Items are scored on a 5-point Likert scale from never (1) to always (5). Total scores can be calculated for each scale with higher scores indicating more positive parenting behaviors. | 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). | 
| Change in mindful parenting practices intervention | The Mindfulness in Parenting Questionnaire (MIPQ) is a 61-item self-report measure of parenting mindfully. Items are scored on a 5-point Likert scale from never to almost always. Raw summed scores can be converted using the MIPQ conversion table to standardized Rasch scores with a mean of 100 and standard deviation of 15, with higher scores indicating more mindfulness in parenting practices. | 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). | 
| Changes in perceived parental/caregiver resilience from pre-intervention to post-intervention | Connor Davidson Resilience Scale - 2 item (CD-RISC) measures resilience and the ability to bounce back after a tragedy, trauma, or stressful event. The measure includes two items scored on a 5-point Likert scale. Total scores range from 0 to 8, with higher scores indicating greater resilience. | 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). | 
| Changes in parent/child screen time pre and post intervention | Screen Time Questionnaire is a self-reported measure of screen time before and during COVID-19. The scale was created for the current study and contains a combination of open-ended and Likert scale questions. No cumulative score is used; instead, items will be evaluated individually. Higher scores on individual Likert scales generally indicate higher screen time use. | 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). | 
| Changes in parental/caregiver spanking practices from pre to post intervention | Parental Spanking will be assessed using a single-item assessing the frequency of spanking on a child's bottom, restricted to the age 2-5 years due to mandatory reporting guidelines for child maltreatment. Higher scores indicate greater frequency. | 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). | 
| Changes in family resources measured from pre to post intervention | Financial Strain will be assessed using a single-item created for a previous study. The item assess strain of managing unexpected expenses. Likert scores are reverse coded with the final score indicating greater financial strain. | 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). | 
| Changes in recent stressful events from pre to post intervention | Recent Stressful Experiences (RSE) is a self-report measure of recent family stressors and coping. This scale was adapted for the current study and contains a combination of open-ended and Likert scale questions. No cumulative score is used; instead, items will be evaluated individually. Higher scores on individual Likert scales assessing stressors indicate more stressors; higher scores on individual Likert scales assessing coping indicate greater resilience. | 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). |