Supporting Parent and Child Engagement

NCT04925258 | Completed

• 1 other identifier: SPACE
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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).

Conditions

Stress, Psychological; Parenting; Covid19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Change in child mental health and behaviour

  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 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 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 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 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 (2)

• Change in child cognitive function

  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).

• Change in child cardiac flexibility

  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).

Study Arms (2)

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.

Behavioral: SPACE Parenting Program

Interventions

SPACE Parenting Program BEHAVIORAL

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.

SPACE Parenting Program

Eligibility Criteria

• Age: 3 Years - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, Canada

Location

Related Publications (20)

• Abidin, R. R. (2012). Parenting stress index (4th ed.). Lutz, FL: PAR.

  BACKGROUND

• 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.

  PMID: 32736186 BACKGROUND

• Connor 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.

  PMID: 12964174 BACKGROUND

• Kroenke 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.

  PMID: 11556941 BACKGROUND

• McCaffrey, 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

• 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.

  PMID: 22629332 BACKGROUND

• McDaniel, 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.

  BACKGROUND

• PROMIS Health Organization & PROMIS Cooperative Group. (2012). Level 2 - Anger - Adult: PROMIS Emotional Distress - Anger - Short Form. Evanston: IL

  BACKGROUND

• Rideout, V. (2017). The Common Sense census: Media use by kids age zero to eight. San Francisco, CA: Common Sense Media

  BACKGROUND

• 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.

  PMID: 16717171 BACKGROUND

• Perrin 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.

  PMID: 27182902 BACKGROUND

• Luthar 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.

  PMID: 28144962 BACKGROUND

• Blair 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.

  PMID: 18606037 BACKGROUND

• Dixon Jr, W. E., & Smith, P. H. (2000). Links between early temperament and language acquisition. Merrill-Palmer Quarterly (1982-), 417-440.

  BACKGROUND

• 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.

  PMID: 16342899 BACKGROUND

• Eisenberg N, Valiente C, Eggum ND. Self-Regulation and School Readiness. Early Educ Dev. 2010 Sep 1;21(5):681-698. doi: 10.1080/10409289.2010.497451.

  PMID: 21234283 BACKGROUND

• Howard SJ, Williams KE. Early Self-Regulation, Early Self-Regulatory Change, and Their Longitudinal Relations to Adolescents' Academic, Health, and Mental Well-Being Outcomes. J Dev Behav Pediatr. 2018 Jul/Aug;39(6):489-496. doi: 10.1097/DBP.0000000000000578.

  PMID: 29781830 BACKGROUND

• Williams, K. E., & Berthelsen, D. (2017). The development of prosocial behaviour in early childhood: Contributions of early parenting and self-regulation. International Journal of Early Childhood, 49(1), 73-94. https ://doi.org/10.1007/s1315 8-017-0185-5.

  BACKGROUND

• Spinelli M, Lionetti F, Setti A, Fasolo M. Parenting Stress During the COVID-19 Outbreak: Socioeconomic and Environmental Risk Factors and Implications for Children Emotion Regulation. Fam Process. 2021 Jun;60(2):639-653. doi: 10.1111/famp.12601. Epub 2020 Sep 28.

  PMID: 32985703 BACKGROUND

• Roos LE, Salisbury M, Penner-Goeke L, Cameron EE, Protudjer JLP, Giuliano R, Afifi TO, Reynolds K. Supporting families to protect child health: Parenting quality and household needs during the COVID-19 pandemic. PLoS One. 2021 May 24;16(5):e0251720. doi: 10.1371/journal.pone.0251720. eCollection 2021.

  PMID: 34029311 BACKGROUND

MeSH Terms

Conditions

Stress, Psychological; COVID-19

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Leslie E Roos, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: June 14, 2021
• Study Start: March 1, 2021
• Primary Completion: October 25, 2021
• Study Completion: February 4, 2025
• Last Updated: July 3, 2025

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: It would become available when the investigators publish the results of the study.
• Access Criteria: Access will be based on the academic journal's level of access and requirements (e.g., subscription). Open access will be preferred at the time of journal selection, as possible, and preprint articles will be submitted online (e.g., psyarxiv) as possible based on journal requirements.

Locations

CA (1)