Family RelationshipsNCT07161063
A Program Evaluation of the Brief Family Therapy Program in the York University Psychology Clinic
A study testing Brief Family Therapy Program in people with Family Relationships and Child Mental Health, run by York University at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 9 years
- Conditions the study is for
- Family Relationships, Child Mental Health, Coparenting
- What is being tested?
- Brief Family Therapy Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2025to Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 2 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Families seeking care for child who is at imminent risk of harm to self or others
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jessica Abrams, PhD contact
Canada1 site
York University
Toronto, Ontario, M3J 1P3
Heather Prime, PhD
Jessica Abrams, PhD
About this study
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.
- Conditions
- Family Relationships, Child Mental Health, Coparenting
- Being tested
- Brief Family Therapy Program
- Keywords
- Brief Family Therapy, Family Systems, Coparenting, Feasibility Study, Implementation Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Family Therapy ProgramBehavioural
Also called LFP-B, Lausanne Trilogue Play-Brief (LTP-B)
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.
| Study group | Role | What they receive |
|---|---|---|
| Brief Family Therapy Program | Experimental | Families will take part in a four-session video-feedback intervention. Receives: Behavioral: Brief Family Therapy Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Referral Sources
Where participants heard about the program (e.g., social media, YUPC, employee, friend)
Measured: Week 0
Participants Enrolled Per month
Number of participants enrolled per month
Measured: Week 0
Service Enrollment Rate
Proportion of participants offered the service versus those who actually sign up
Measured: Week 0
Reasons for Non-Enrollment
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.)
Measured: Week 0
Waitlist Duration
Time in days from initial intake call to first phone call with clinician
Measured: Week 0
Participant Education
The percentage of participants with less than or equal to a high school degree.
Measured: Week 1
Geographic Reach
Cities/towns in Ontario families accessing the program reside
Measured: Week 0
Retention
The percentage of participants who remain in study until the end of the follow up session.
Measured: Week 8
Service Uptake
The percentage of participants reporting some reflection about coparenting outside of sessions.
Measured: Week 8
Client Acceptability
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.
Measured: Week 8
Clinician Acceptability
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.
Measured: Week 8
Working Alliance Inventory
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.
Measured: Longitudinal change across week 1 to week 8
Pre-Post Change in Parent Reported Coparenting Relationship
Using the Coparenting Scale-Revised (McHale, 1999; unpublished manuscript). Minimum score=18, maximum score=90. Higher scores correspond to a greater frequency of outcomes.
Measured: Pre-post change from week 1 to week 8
Secondary outcomes (5)
Pre-Post Change in Parenting Stress
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).
Measured: Pre-post change from week 1 to week 8
Pre-Post Change in Child Reported Coparenting Relationship
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.
Measured: Pre-post change from week 2 to week 8
Pre-Post Change in Parent and Child Family Adjustment
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).
Measured: Pre-post change from week 1 to week 8
Pre-Post Change in Child Emotional Distress (i.e., Anger, Anxiety, and Depressive Symptoms)
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).
Measured: Pre-post change from week 0 to week 8
Pre-Post Change in Child Externalizing Problems
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).
Measured: Pre-post change from week 1 to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Family RelationshipsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- York University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne
- Responsible party
- Principal investigator, Heather Prime, York University
- Investigators
- Heather Prime, PhD, Principal investigator, York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161063
- Sponsor's protocol ID
- e2025-244
- Status last verified
- Sep 2025
- First submitted
- 29 Aug 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28117056Graziano 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.
PubMed 32352803Philipp 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.
PubMed 36959726Carr, 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 at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Program Evaluation of the Brief Family Therapy Program in the York University Psychology Clinic
- ClinicalTrials.gov ID
- NCT07161063
- Acronym / sponsor ID
- e2025-244
- Conditions
- Family Relationships, Child Mental Health, Coparenting
- Keywords
- Brief Family Therapy, Family Systems, Coparenting, Feasibility Study, Implementation Study
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- York UniversityUniversity, hospital or other
- Collaborators
- University of Lausanne
- Study start
- Sep 2025 (estimated)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 8 Sep 2025 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brief Family Therapy Program | Experimental | Behavioral: Brief Family Therapy ProgramFamilies will take part in a four-session video-feedback intervention. |
Who may qualify
- Ages
- 2 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Families seeking care for child who is at imminent risk of harm to self or others
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 |
|---|---|---|
| Brief Family Therapy ProgramAlso: LFP-B, Lausanne Trilogue Play-Brief (LTP-B)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. | Behavioural | Brief Family Therapy Program |
Primary outcome
Referral Sources
Time frame: Week 0
Where participants heard about the program (e.g., social media, YUPC, employee, friend)
Participants Enrolled Per month
Time frame: Week 0
Number of participants enrolled per month
Service Enrollment Rate
Time frame: Week 0
Proportion of participants offered the service versus those who actually sign up
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.)
Waitlist Duration
Time frame: Week 0
Time in days from initial intake call to first phone call with clinician
Participant Education
Time frame: Week 1
The percentage of participants with less than or equal to a high school degree.
Geographic Reach
Time frame: Week 0
Cities/towns in Ontario families accessing the program reside
Retention
Time frame: Week 8
The percentage of participants who remain in study until the end of the follow up session.
Service Uptake
Time frame: Week 8
The percentage of participants reporting some reflection about coparenting outside of sessions.
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.
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.
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.
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.
5 secondary outcomes
Pre-Post Change in Parenting Stress
Time frame: 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
Pre-Post Change in Parent and Child Family Adjustment
Time frame: 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
Pre-Post Change in Child Externalizing Problems
Time frame: Pre-post change from week 1 to week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Background: PubMed 28117056Schleider 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.
- Background: PubMed 32352803Graziano 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.
- Background: PubMed 36959726Philipp 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.
- BackgroundCarr, 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
- BackgroundKaram, 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
- Individual participant dataSharing planned: No
Related trials for Family Relationships
Enrolling by invitation
Attitudes, Experience and Adaptation to Family Presence in the ICU
ICU Staff Attitudes Toward Family Presence, ICU Staff Experience of Family Presence
Recruiting
Applying CSNAT in HBPC as an Approach to Elder Mistreatment Risk Reduction
Caregiver Stress, Caregiver Health Related QOL
Recruiting
A SMART Evaluation of an Adaptive Web-based AUD Treatment for Service Members and Their Partners
Alcohol Abuse, Alcohol Use Disorder
Recruiting
Family Spirit Strengths
Depressive Symptoms, Anxiety Disorders and Symptoms
Not yet recruiting
A Mobile App to Support Mood, Daily Routines and Medication Adherence in Adults With Severe Mental Illness
Severe Mental Illness, Bipolar Disorder
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.
Jessica Abrams, PhD contact
Heather Prime, PhD principal investigator
York University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Family Therapy Program in people with Family Relationships and Child Mental Health, run by York University 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 5 inclusion and 1 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: opening soon, as of the sponsor's last update on 12 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heather Prime, PhD ((416)736-5117, hprime@yorku.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Referral Sources (time frame: Week 0). The study lists 13 primary outcomes in all. 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 NCT07161063, which also lists 5 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 12 Sep 2025.