NCT07351630

Brief Summary

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:

  1. 1.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.
  2. 2.Examining sample and clinical characteristics of those attending the BBFW service
  3. 3.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.
  4. 4.Evaluating and refining the program quality using participant quantitative and qualitative feedback.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Oct 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Oct 2025Nov 2026

Study Start

First participant enrolled

October 20, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 27, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

1.1 years

First QC Date

November 27, 2025

Last Update Submit

January 9, 2026

Conditions

Keywords

Program EvaluationFamily SystemsFeasibility StudyParenting InterventionCaregiversParents

Outcome Measures

Primary Outcomes (11)

  • Participants Enrolled Per month

    Number of participants enrolled per month.

    Week 0

  • Geographic Reach

    Cities/towns in Ontario families accessing the program reside. Data will be collected through the demographic questionnaire administered at baseline.

    Week 0

  • Retention

    The percentage of participants who remain in study until the end of the follow up session.

    Week 0 to Week 18

  • Adherence

    Number of sessions attended.

    Week 1 to Week 6

  • Adherence

    Completion rate of in session activities.

    Week 6

  • Child Age Groups

    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

    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

    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

    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

    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

    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 Outcomes (2)

  • Pre-Post Change in Parent Reported 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

    Changes from Week 0 to Week 6; from Week 0 to Week 10; from Week 0 to Week 18

Study Arms (1)

Experimental: Parent Skills Group Program

EXPERIMENTAL

Caregivers who take part in a 6-week group program on parenting skills

Behavioral: Building Blocks for Family Well-being

Interventions

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.

Experimental: Parent Skills Group Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Caregivers who do not consent to participate in research.
  • Caregivers whose children are older than 18 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

York University,

Toronto, Ontario, M3J 1P3, Canada

NOT YET RECRUITING

York University Psychology Clinic

Toronto, Ontario, Canada

RECRUITING

Related Publications (4)

  • 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.

    PMID: 36959726BACKGROUND
  • Lafrance, A., Henderson, K. A., & Mayman, S. (2020). Emotion-focused family therapy: A transdiagnostic model for caregiver-focused interventions. American Psychological Association

    BACKGROUND
  • 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.

    PMID: 18826532BACKGROUND
  • 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.

    PMID: 39572487BACKGROUND

Study Officials

  • Heather Prime, PhD

    York University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather Prime, PhD

CONTACT

Truong Phuong Anh Nguyen, BA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Profesor

Study Record Dates

First Submitted

November 27, 2025

First Posted

January 20, 2026

Study Start

October 20, 2025

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations