- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07161063
- Original Trial
A Program Evaluation of the Brief Family Therapy Program in the York University Psychology Clinic
September 5, 2025 updated by: Heather Prime, York University
Background.
Children are vulnerable to mental health challenges during development.
Given that youth are reliant on their parents for support, understanding the child's symptoms within the family context is critical for promoting positive change.
This proposal focuses on "systemic therapy", or family-based therapy, which seeks to enhance children's mental health by improving the relationships and communication between family members (1).
Most family-based therapies for treating child mental health problems are intense in duration and frequency (2), which is a barrier to access for many families.
Shorter-term family therapies or what will be referred to hereafter as brief family-based therapies are effective in treating a variety of child symptoms, while also minimizing participant burden and therapy dropout (3).
One type of brief family-based therapy model is the Lausanne Family Play - Brief (LFP-B), a three-session service that utilizes a play-based family observational assessment with video feedback to draw attention to and catalyze change in challenging family interactions.
The LFP has been widely researched as a clinical assessment tool and has been implemented as a brief family-based therapy program (4).
The current project represents the implementation and evaluation of the program in the York University Psychology Clinic (YUPC), which services children, adults, couples, and families in the Greater Toronto Area (and Ontario, broadly).
The current study will be the first to evaluate the implementation, acceptability, and effectiveness of the LFP-B as a clinic service.
Objectives.
The aim of this project is to evaluate the LFP-B as a brief family-based clinical service offered in the YUPC.
The first objective is to explore program acceptability for both clients and therapists.
The investigators are interested in whether clients and therapists are satisfied with this clinical service and its processes.
The second objective is to assess program effectiveness, specifically whether coparenting, family functioning, and child mental health problems improve across the course of the program and in the months following.
Importance.
Brief therapies with a systemic lens can increase cost-effectiveness, accessibility, and treatment retention.
They also have potential to fill an apparent gap in service needs as up to three-quarters of youth with psychological concerns never receive treatment (5).
Thus, brief services can provide more timely access to mental health care in Canada which have potential for reducing wait times, preventing further deterioration in mental health, and avoiding more intensive and expensive higher levels of care (e.g., acute inpatient mental health services; (6)).
The LFP-B has potential to be widely used as a brief family-based therapy program with Canadian families to support child and family functioning in a timely and non-intensive manner.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Heather Prime, PhD
- Phone Number: (416)736-5117
- Email: hprime@yorku.ca
Study Contact Backup
- Name: Jessica Abrams, PhD
- Email: schroede@yorku.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M3J 1P3
- York University
-
Contact:
- Heather Prime, PhD
-
Sub-Investigator:
- Jessica Abrams, PhD
-
Sub-Investigator:
- Yvonne Bohr, PhD
-
Sub-Investigator:
- Joëlle Darwiche, PhD
-
Sub-Investigator:
- Diane Philipp, MD
-
Sub-Investigator:
- Gillian Shoychet, MA
-
Sub-Investigator:
- Maya Koven, MA
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Both primary caregivers are over age 18 years
- Families living in Ontario, Canada
- Primary caregivers endorses caring for a child between 2 to 9 years old with a mental health challenge (e.g., anxiety, low mood, behavioural challenges) or mild/moderate levels of family distress
- Both caregivers and child agree to participate
- Family must have access to a screen (phone, tablet, computer) and internet for virtual services and recording.
Exclusion Criteria:
- Families seeking care for child who is at imminent risk of harm to self or others
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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: Brief Family Therapy Program
Families will take part in a four-session video-feedback intervention.
|
The Lausanne Family Play - Brief is a video-feedback intervention adapted for families seeking support for a child two to nine years old with a mental health challenge.
Feedback focuses on engagement, teamwork, conflict, and child-focused issues.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Referral Sources
Time Frame: Week 0
|
Where participants heard about the program (e.g., social media, YUPC, employee, friend)
|
Week 0
|
|
Participants Enrolled Per month
Time Frame: Week 0
|
Number of participants enrolled per month
|
Week 0
|
|
Service Enrollment Rate
Time Frame: Week 0
|
Proportion of participants offered the service versus those who actually sign up
|
Week 0
|
|
Reasons for Non-Enrollment
Time Frame: Week 0
|
Reasons for not joining the service for those who were offered it (e.g., scheduling multiple caregivers, desire for child-focused treatment, cost, time commitment, etc.)
|
Week 0
|
|
Waitlist Duration
Time Frame: Week 0
|
Time in days from initial intake call to first phone call with clinician
|
Week 0
|
|
Participant Education
Time Frame: Week 1
|
The percentage of participants with less than or equal to a high school degree.
|
Week 1
|
|
Geographic Reach
Time Frame: Week 0
|
Cities/towns in Ontario families accessing the program reside
|
Week 0
|
|
Retention
Time Frame: Week 8
|
The percentage of participants who remain in study until the end of the follow up session.
|
Week 8
|
|
Service Uptake
Time Frame: Week 8
|
The percentage of participants reporting some reflection about coparenting outside of sessions.
|
Week 8
|
|
Client Acceptability
Time Frame: Week 8
|
Looking for the 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 8
|
|
Clinician Acceptability
Time Frame: Week 8
|
Looking for the percentage of clinicians 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 8
|
|
Working Alliance Inventory
Time Frame: Longitudinal change across week 1 to week 8
|
Exploratory for pattern of scores across the intervention on a Working Alliance Inventory Scale that will assess client perceptions of goals, tasks, and bonds during intervention.
Scores range from 12-60 with higher scores representing greater self-reported alliance.
|
Longitudinal change across week 1 to week 8
|
|
Pre-Post Change in Parent Reported Coparenting Relationship
Time Frame: Pre-post change from week 1 to week 8
|
Using the Coparenting Scale-Revised (McHale, 1999; unpublished manuscript).
Minimum score=18, maximum score=90.
Higher scores correspond to a greater frequency of outcomes.
|
Pre-post change from week 1 to week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pre-Post Change in Parenting Stress
Time Frame: Pre-post change from week 1 to week 8
|
Using the Parental Stress Scale (PSS; Berry & Jones, 1995).
Minimum score=18, maximum score=90.
Higher scores correspond to worse outcomes (i.e., more stress).
|
Pre-post change from week 1 to week 8
|
|
Pre-Post Change in Child Reported Coparenting Relationship
Time Frame: Pre-post change from week 2 to week 8
|
Using the Child Perspectives on the Coparenting Relationship - Revised (created based on McHale's 1999 Coparenting Scale - Revised).
Minimum score=7, maximum score=21.
Higher scores correspond to a greater frequency of outcomes.
|
Pre-post change from week 2 to week 8
|
|
Pre-Post Change in Parent and Child Family Adjustment
Time Frame: Pre-post change from week 1 to week 8
|
Using the Parenting and Family Adjustment Scale (PAFAS; Sanders & Morawska, 2010).
Minimum score=0, maximum score=90.
Higher scores correspond to worse outcomes (i.e., higher levels of dysfunction).
|
Pre-post change from week 1 to week 8
|
|
Pre-Post Change in Child Emotional Distress (i.e., Anger, Anxiety, and Depressive Symptoms)
Time Frame: Pre-post change from week 0 to week 8
|
Using the subscales of the Emotion Distress scale of the Patient-Reported Outcomes Measurement Information System (NIH) Parent Proxy Domains (ages 5-17) or Early Childhood Parent Report (ages 1-5).
Ages 5-17 minimum score = 19, maximum score = 120 Ages 1-5 minimum score = 24, maximum score = 120.
Higher scores correspond to worse outcomes (i.e., more emotional distress).
|
Pre-post change from week 0 to week 8
|
|
Pre-Post Change in Child Externalizing Problems
Time Frame: Pre-post change from week 1 to week 8
|
Using the Externalizing Problems subscale of the Behavior and Feelings Survey (BFS) Caregiver Report Form (Weisz et al., 2019).
Minimum score=0, maximum score=24.
Higher scores correspond to worse outcomes (i.e., more behavioural problems).
|
Pre-post change from week 1 to week 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Heather Prime, PhD, York University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Schleider JL, Weisz JR. Little Treatments, Promising Effects? Meta-Analysis of Single-Session Interventions for Youth Psychiatric Problems. J Am Acad Child Adolesc Psychiatry. 2017 Feb;56(2):107-115. doi: 10.1016/j.jaac.2016.11.007. Epub 2016 Nov 25.
- Graziano PA, Ros-Demarize R, Hare MM. Condensing parent training: A randomized trial comparing the efficacy of a briefer, more intensive version of Parent-Child Interaction Therapy (I-PCIT). J Consult Clin Psychol. 2020 Jul;88(7):669-679. doi: 10.1037/ccp0000504. Epub 2020 Apr 30.
- 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.
- Carr, A. (2019). Family therapy and systemic interventions for child-focused problems: the current evidence base. Journal of Family Therapy, 41(2), 153-213. https://doi.org/10.1111/1467-6427.12226
- Karam, E. A., Blow, A. J., Wampler, K. S., Seedall, R. B., & Miller, R. B. (2020). Common Factors Underlying Systemic Family Therapy. In The Handbook of Systemic Family Therapy (pp. 147-169). John Wiley & Sons, Ltd. https://doi.org/10.1002/9781119438519.ch7
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2025
Primary Completion (Estimated)
August 1, 2029
Study Completion (Estimated)
August 1, 2029
Study Registration Dates
First Submitted
August 29, 2025
First Submitted That Met QC Criteria
August 29, 2025
First Posted (Estimated)
September 8, 2025
Study Record Updates
Last Update Posted (Estimated)
September 12, 2025
Last Update Submitted That Met QC Criteria
September 5, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- e2025-244
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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