Stress, PsychologicalSPACENCT04925258
Supporting Parent and Child Engagement
A study testing SPACE Parenting Program in people with Stress, Psychological and Parenting, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 4 years
- Conditions the study is for
- Stress, Psychological, Parenting, Covid19
- What is being tested?
- SPACE Parenting Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2021to 4 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Supporting Parent and Child Engagement - SPACE Parenting Program
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).
Read the 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:
- 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.
- Conditions
- Stress, Psychological, Parenting, Covid19
- Being tested
- SPACE Parenting Program
- Medical subject headings
- Stress, Psychological, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPACE Parenting ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Services-as-usual | No intervention | Services-as-usual (referral list for online and telehealth parenting and family mental health services). |
| SPACE Parenting Program | Experimental | 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. Receives: Behavioral: SPACE Parenting Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: : 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 (13)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start1 Mar 2021
- Primary completion25 Oct 2021
- Study completion4 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leslie E Roos, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04925258
- Sponsor's protocol ID
- SPACE
- Acronym
- SPACE
- Status last verified
- Apr 2021
- First submitted
- 3 May 2021
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators may share data linked only to a de-identified number and without identifiable information (e.g., no videos, birthdates etc.), on online open science data repositories, such as osf.io).
Publications
Abidin, R. R. (2012). Parenting stress index (4th ed.). Lutz, FL: PAR.
Cameron EE, Joyce KM, Delaquis CP, Reynolds K, Protudjer JLP, Roos LE. Maternal psychological distress & mental health service use during the COVID-19 pandemic. J Affect Disord. 2020 Nov 1;276:765-774. doi: 10.1016/j.jad.2020.07.081. Epub 2020 Jul 20.
PubMed 32736186Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113.
PubMed 12964174Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941McCaffrey, S., Reitman, D., & Black, R. (2017). Mindfulness in Parenting Questionnaire (MIPQ): Development and validation of a measure of mindful parenting. Mindfulness, 8(1), 232-246.
Mieloo C, Raat H, van Oort F, Bevaart F, Vogel I, Donker M, Jansen W. Validity and reliability of the strengths and difficulties questionnaire in 5-6 year olds: differences by gender or by parental education? PLoS One. 2012;7(5):e36805. doi: 10.1371/journal.pone.0036805. Epub 2012 May 18.
PubMed 22629332McDaniel, B. T., Everest, J., & White, C. (April 2018). Parent distraction with technology and its impact on parenting quality. Poster presentation: Illinois Council on Family Relations. Normal, IL.
PROMIS Health Organization & PROMIS Cooperative Group. (2012). Level 2 - Anger - Adult: PROMIS Emotional Distress - Anger - Short Form. Evanston: IL
Rideout, V. (2017). The Common Sense census: Media use by kids age zero to eight. San Francisco, CA: Common Sense Media
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Perrin EC, Leslie LK, Boat T. Parenting as Primary Prevention. JAMA Pediatr. 2016 Jul 1;170(7):637-8. doi: 10.1001/jamapediatrics.2016.0225. No abstract available.
PubMed 27182902Luthar SS, Eisenberg N. Resilient Adaptation Among At-Risk Children: Harnessing Science Toward Maximizing Salutary Environments. Child Dev. 2017 Mar;88(2):337-349. doi: 10.1111/cdev.12737. Epub 2017 Feb 1.
PubMed 28144962Blair C, Diamond A. Biological processes in prevention and intervention: the promotion of self-regulation as a means of preventing school failure. Dev Psychopathol. 2008 Summer;20(3):899-911. doi: 10.1017/S0954579408000436.
PubMed 18606037Dixon Jr, W. E., & Smith, P. H. (2000). Links between early temperament and language acquisition. Merrill-Palmer Quarterly (1982-), 417-440.
Eisenberg N, Sadovsky A, Spinrad TL. Associations of emotion-related regulation with language skills, emotion knowledge, and academic outcomes. New Dir Child Adolesc Dev. 2005 Fall;(109):109-18. doi: 10.1002/cd.143.
PubMed 16342899
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Parent and Child Engagement - SPACE Parenting Program
- ClinicalTrials.gov ID
- NCT04925258
- Acronym / sponsor ID
- SPACE / SPACE
- Conditions
- Stress, Psychological, Parenting, Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 25 Oct 2021 (actual)
- Study completion
- 4 Feb 2025 (actual)
- First posted
- 14 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Services-as-usual | No intervention | –Services-as-usual (referral list for online and telehealth parenting and family mental health services). |
| SPACE Parenting Program | Experimental | Behavioral: SPACE Parenting ProgramThe 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. |
Who may qualify
- Ages
- 3 to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPACE Parenting ProgramThe 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. | Behavioural | SPACE Parenting Program |
Primary outcome
Change in parenting stress
Time frame: : 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
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.
13 secondary outcomes
Change in child mental health and behaviour
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- BackgroundAbidin, R. R. (2012). Parenting stress index (4th ed.). Lutz, FL: PAR.
- Background: PubMed 32736186Cameron EE, Joyce KM, Delaquis CP, Reynolds K, Protudjer JLP, Roos LE. Maternal psychological distress & mental health service use during the COVID-19 pandemic. J Affect Disord. 2020 Nov 1;276:765-774. doi: 10.1016/j.jad.2020.07.081. Epub 2020 Jul 20.
- Background: PubMed 12964174Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113.
- Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- BackgroundMcCaffrey, S., Reitman, D., & Black, R. (2017). Mindfulness in Parenting Questionnaire (MIPQ): Development and validation of a measure of mindful parenting. Mindfulness, 8(1), 232-246.
- Background: PubMed 22629332Mieloo C, Raat H, van Oort F, Bevaart F, Vogel I, Donker M, Jansen W. Validity and reliability of the strengths and difficulties questionnaire in 5-6 year olds: differences by gender or by parental education? PLoS One. 2012;7(5):e36805. doi: 10.1371/journal.pone.0036805. Epub 2012 May 18.
- BackgroundMcDaniel, B. T., Everest, J., & White, C. (April 2018). Parent distraction with technology and its impact on parenting quality. Poster presentation: Illinois Council on Family Relations. Normal, IL.
- BackgroundPROMIS Health Organization & PROMIS Cooperative Group. (2012). Level 2 - Anger - Adult: PROMIS Emotional Distress - Anger - Short Form. Evanston: IL
- BackgroundRideout, V. (2017). The Common Sense census: Media use by kids age zero to eight. San Francisco, CA: Common Sense Media
- Background: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Background: PubMed 27182902Perrin EC, Leslie LK, Boat T. Parenting as Primary Prevention. JAMA Pediatr. 2016 Jul 1;170(7):637-8. doi: 10.1001/jamapediatrics.2016.0225. No abstract available.
- Background: PubMed 28144962Luthar SS, Eisenberg N. Resilient Adaptation Among At-Risk Children: Harnessing Science Toward Maximizing Salutary Environments. Child Dev. 2017 Mar;88(2):337-349. doi: 10.1111/cdev.12737. Epub 2017 Feb 1.
- Individual participant dataSharing planned: Yes. The investigators may share data linked only to a de-identified number and without identifiable information (e.g., no videos, birthdates etc.), on online open science data repositories, such as osf.io).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leslie E Roos, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPACE Parenting Program in people with Stress, Psychological and Parenting, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in parenting stress (time frame: : 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04925258, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.