- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07351630
Building Blocks for Child and Family Well-being (BBFW)
Feasibility, Acceptability, and Program Evaluation of A Parent Group to Support Child and Family Well-being
Background. Understanding emotions, stress, and conflicts within the family context is critical for promoting positive change. However, most support services for families often address child development, parenting, couple relationships separately without considering these as interacting systems that contributes to overall family well-being. This project is to evaluate an existing clinical service in York University Psychology Clinic (YUPC), "Building Blocks for Child and Family Well-being" (BBFW), which provides an integrated understanding of the family context, and equips caregivers with tools to help families connect, problem-solve, cope with stress, and thrive. BBFW is a brief virtual program that promotes experiential learning, provides individually tailored strategies, and builds a community of support for caregivers. The current study aims to examine the feasibility, acceptability, and effectiveness of the BBFW program within the York University Psychology Clinic (YUPC), with four objectives:
- Evaluating the feasibility of implementing the BBWF program into YUPC clinical services, represented by enrolment rates, sample characteristics, retention (i.e., number of sessions attended, % dropout), adherence (i.e., completing in- and out-of-session activities), as well as the acceptability of the program among participants.
- Examining sample and clinical characteristics of those attending the BBFW service
- Exploring the effectiveness of the BBFW program through changes in family functioning and meta-emotion philosophy from pre- to post-intervention, as well as changes at 1- and 3-month follow-ups.
- Evaluating and refining the program quality using participant quantitative and qualitative feedback.
The BBFW program is based on the best evidence from developmental, family, and relationship science. It aims to support family mental health and well-being through a holistic and sustainable approach, viewing the family as a set of multiple, interdependent systems. This program provides a brief, cost-effective, and accessible alternative with the potential to reduce the burden on traditional mental health and support services for Canadian families.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Heather Prime, PhD
- Phone Number: 416-736-5117
- Email: hprime@yorku.ca
Study Contact Backup
- Name: Truong Phuong Anh Nguyen, BA
- Phone Number: 647-892-5519
- Email: anhtpng@yorku.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M3J 1P3
- Not yet recruiting
- York University,
-
Sub-Investigator:
- Gillian Shoychet, MA
-
Contact:
- Heather Prime, PhD
- Phone Number: 416-736-5117
- Email: hprime@yorku.ca
-
Contact:
- Truong Phuong Anh Nguyen, BA
- Phone Number: 647-892-5519
- Email: anhtpng@yorku.ca
-
Sub-Investigator:
- Madison Aitken, PhD
-
Toronto, Ontario, Canada
- Recruiting
- York University Psychology Clinic
-
Contact:
- Jessica Westcott
- Phone Number: (416) 650-8488
- Email: schroede@yorku.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Caregivers aged 18 years or older participating in the BBFW program at York Univeristy's Psychology Clinic in Toronto, Ontario, Canada.
- Caregivers with children 18 years old or under are eligible to participate in the BBFW program.
- Caregivers must be residing in Ontario at the time of their service.
- Caregivers must also have access to a digital device with a screen (e.g., phone, tablet, computer) that can be used for virtual services.
Exclusion Criteria:
- Caregivers who do not consent to participate in research.
- Caregivers whose children are older than 18 years old.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental: Parent Skills Group Program
Caregivers who take part in a 6-week group program on parenting skills
|
BBFW is a 6-week brief virtual program that promotes experiential learning, provides individually tailored strategies, and builds a community of support for caregivers.
The program provides an integrated understanding of the family context, and equips caregivers with tools to help families connect, problem-solve, cope with stress, and thrive.
The following topics are covered over 6 weeks: Introduction to the model; Getting to Know Your Family Members (e.g., temperament); Supporting Child Emotions; Promoting Positive Behaviours; Limit-Setting and Sibling Dynamics; Parenting Teams and Wrap-Up.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participants Enrolled Per month
Time Frame: Week 0
|
Number of participants enrolled per month.
|
Week 0
|
|
Geographic Reach
Time Frame: Week 0
|
Cities/towns in Ontario families accessing the program reside.
Data will be collected through the demographic questionnaire administered at baseline.
|
Week 0
|
|
Retention
Time Frame: Week 0 to Week 18
|
The percentage of participants who remain in study until the end of the follow up session.
|
Week 0 to Week 18
|
|
Adherence
Time Frame: Week 1 to Week 6
|
Number of sessions attended.
|
Week 1 to Week 6
|
|
Adherence
Time Frame: Week 6
|
Completion rate of in session activities.
|
Week 6
|
|
Child Age Groups
Time Frame: Week 0
|
Mean age of child of the parent who is seeking service.
Data will be collected through the demographic questionnaire administered at baseline.
|
Week 0
|
|
Primary Presenting Concern
Time Frame: Week 0
|
Primary presenting concern of parent who is seeking service, collected at baseline using demographic questionnaire.
Options include: child emotion regulation; child behavioural problems; challenging siblings dynamics; challenging co-parenting dynamics (working as a team with second parent); family stress, chaos, and/or conflict; other [please specify].
|
Week 0
|
|
Family Clinical Characteristics
Time Frame: Week 2
|
Family Clinical Characteristics include parent relationship dimension.
The Relationship Dimension Scale (Lafrance, Henderson, & Mayman, 2020) is a 14-item tool for parents to reflect on different aspect of their relationships with their child/children.
This is a qualitative measure that will be examined for themes arising in participating caregivers.
|
Week 2
|
|
Family Clinical Characteristics
Time Frame: Week 1
|
Family Clinical Characteristics include parent stress.
The Family Stress Checklist includes 35 items which measures a parent's level of stress in 7 areas (i.e., financial, professional, physical, relational, environmental, child, parenting, discrimination).
Each item is rated on a 5-item scale.
Mean of items in each area will be calculated, with minimum score=1, maximum score=5.
Higher scores correspond to higher level of stress in each area.
|
Week 1
|
|
Client Satisfaction
Time Frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
|
Client Satisfaction will be measured using surveys and participant qualitative feedback.
A brief satisfaction survey will be administered weekly at the end of each group session.
This survey consists of 4 questions about the content, facilitation, group activities/discussion, as well as an open-ended question for general feedback about the session.
In the end, participant will be asked to complete another satisfaction survey about the program overall.
Means of the survey items will be calculated.
Minimum score=1, maximum score=4.
Higher scores correspond to higher satisfaction.
|
Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
|
|
Client Acceptability
Time Frame: Week 6
|
Percentage of participants reporting at least 'good' on 80 % or more indicators on an Implementation Acceptability Scale that will assess attitude, burden, perceived effectiveness, and ethicality.
Minimum score=7, maximum score=35.
Higher scores correspond to better outcomes.
|
Week 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pre-Post Change in Parent Reported Family Functioning
Time Frame: Changes from Week 0 to Week 6; from Week 0 to Week 10; from Week 0 to Week 18
|
Changes in Family Functioning will be assessed using the McMaster Family Assessment Device (FAD; Epstein et al., 1983).
The scale has 60 items representing 7 subscales: Problem Solving, Communication, Roles, Affective Responsiveness, Affective Involvement, Behavior Control, General Functioning.
Each item is rated on 4 point scale.
Mean of each subscale will be calculated.
For each subscale, minimum score=1, maximum score=4.
Higher scores correspond to worse outcomes (i.e., less healthy family functioning).
|
Changes from Week 0 to Week 6; from Week 0 to Week 10; from Week 0 to Week 18
|
|
Pre-Post Change in Parent Meta-Emotion Philosophy
Time Frame: Changes from Week 0 to Week 6; from Week 0 to Week 10; from Week 0 to Week 18
|
Changes in Parent Meta-Emotion Philosophy will be assessed using the Emotion-Related Parenting Styles Scale-Short Form (ERPS-SF; Paterson et al., 2012). The scale has 20 items, each rated on a 5-point Likert Scale. Mean of items representing 4 parenting styles will be calculated. For each parenting style, minimum score=1, maximum score=5. The style with highest average score indicates the participant's emotion-related parenting style. |
Changes from Week 0 to Week 6; from Week 0 to Week 10; from Week 0 to Week 18
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Heather Prime, PhD, York University
Publications and helpful links
General Publications
- Dishion TJ, Shaw D, Connell A, Gardner F, Weaver C, Wilson M. The family check-up with high-risk indigent families: preventing problem behavior by increasing parents' positive behavior support in early childhood. Child Dev. 2008 Sep-Oct;79(5):1395-414. doi: 10.1111/j.1467-8624.2008.01195.x.
- Philipp DA, Prime H, Darwiche J. An ultra-brief systemic intervention to address child mental health symptomatology. Fam Process. 2023 Jun;62(2):469-482. doi: 10.1111/famp.12875. Epub 2023 Mar 23.
- Lafrance, A., Henderson, K. A., & Mayman, S. (2020). Emotion-focused family therapy: A transdiagnostic model for caregiver-focused interventions. American Psychological Association
- Bennett T, Georgiades K, Gonzalez A, Janus M, Lipman E, Pires P, Prime H, Duku E, Jambon M, McLennan JD, Gross J; Making the Race Fair Study Team. Targeted Child Mental Health Prevention and Parenting Support Within a Canadian Context: A Randomized Controlled Trial Evaluating the U.S.-Developed Family Check-Up(R). Prev Sci. 2025 May;26(4):555-567. doi: 10.1007/s11121-024-01741-3. Epub 2024 Nov 22. Erratum In: Prev Sci. 2025 Jul;26(5):849. doi: 10.1007/s11121-024-01764-w.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 4745
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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