- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05356247
Lausanne Trialogue Paradigm - Brief: A Family Model for Child Mental Health in a Community Setting (LTP-B)
Lausanne Trialogue Paradigm - Brief: A Family Systems Model to Address Child Mental Health in a Community Mental Health Setting
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Heather Prime, PhD
- Phone Number: 4168197331
- Email: hprime@yorku.com
Study Contact Backup
- Name: Diane Philipps, PhD
Study Locations
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Ontario
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Toronto, Ontario, Canada, M3J 1P3
- Recruiting
- York University
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Contact:
- Heather Prime, PhD
- Email: hprime@yorku.ca
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Principal Investigator:
- Heather Prime, PhD
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Principal Investigator:
- Diane Philipps, PhD
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Principal Investigator:
- Joelle Darwiche, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The sample will comprise of families referred to the outpatient mental health services at Sick Kids Center for Community Mental Health (SKCCMH), a non-profit children's mental health treatment centre in Toronto, ON, Canada.
- Participants will include children ages 0 months to 15.11 years old, and their caregivers, though the majority will fall in the range of 3- to 14-years-old.
- The first 25 families to be referred to the LTP-B service and who agree to participate in research will be included.
Exclusion Criteria:
- No exclusion criteria beyond what is standard for the clinical service at SKCCMH.
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: LTP-B Intervention
Families will take part in an online semi-structured assessment and video feedback paradigm of family interactions, with an emphasis on co-parenting and parent-child relations.
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The brief treatment program will consist of an LTP family assessment with video feedback to caregivers to address family interaction patterns and child mental health.
Families will participate in four sessions conducted online using the Zoom for Healthcare platform.
In the first session, families will engage in a family assessment in different groupings that will be recoded on zoom and used later in the treatment.
In the second session, taking place one week later, families will take part in a mini assessment to learn more about the difficulties of the child.
In the third session, the clinical team will share videos of the family assessment to the parents and discuss the families strengths, concerns, and goals for moving forward.
In the fourth session, taking place one month after the third session, families will participate in a check-in session, debriefing the family assessment.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
COVID-19-related Family Stressors
Time Frame: Time 0, 3
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Descriptive (no criterion for success): Family Stressor Scale.
Minimum score=16, maximum score=48.
Higher scores correspond to worse outcomes.
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Time 0, 3
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COVID-19-related Family Positive Adaptation
Time Frame: Time 0, 3
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Descriptive (no criterion for success): COVID-19 Family Positive Adaptation Scale.
Minimum score=14, maximum score=42.
Higher scores correspond to better outcomes.
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Time 0, 3
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Therapeutic Alliance
Time Frame: Time 1, 2, 3, 5
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Descriptive (no criterion for success): Working Alliance Inventory-Short Revised (WAI-SR).
Minimum score=12, maximum score=60.
Higher scores correspond to better outcomes.
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Time 1, 2, 3, 5
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Form Research-Clinical Partnership (1) - Clinical-Research Meetings
Time Frame: Time -1 to end of study
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Criterion for success: Meet once monthly throughout the course of the study.
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Time -1 to end of study
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Form Research-Clinical Partnership (2) - Protocol Development - a
Time Frame: Time -1
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Criterion for success: Administrative approval from SKCCMH for study (via approval of ethics approval).
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Time -1
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Form Research-Clinical Partnership (3) - Protocol Development - b
Time Frame: Time -1
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Criterion for success: Submission of protocol for registration to clinicaltrials.gov
and/or journal publications.
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Time -1
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Research-Clinical Communication (1) - Clients Referred to LTP-B
Time Frame: Time -1
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Criterion for success: 95% of clients referred to LTP-B to be asked permission to be contacted by the research team.
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Time -1
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Research-Clinical Communication (2) - Clients Transferred to Research Team
Time Frame: Time -1
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Criterion for success: 95% of clients that agree to research are transferred to the research team for contact.
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Time -1
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Research-Clinical Communication (3) - Clinical Visits Shared
Time Frame: Time -1 to end of study
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Criterion for success: 95% of participants' scheduled clinical visits to be shared with the research team.
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Time -1 to end of study
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Research-Clinical Communication (4) - Videos Shared
Time Frame: Time 1, 2, 3
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Criterion for success: 95% of participant videos (previously consented) to be successfully shared with the research team.
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Time 1, 2, 3
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Clinical Service Flow (1) - Clients Referred
Time Frame: Time -1
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Criterion for success: 3 families to be referred to the LTP-B per month.
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Time -1
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Clinical Service Flow (2) - Service Provision
Time Frame: Time -1
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Criterion for success: 2 families to be seen by the LTP-B team per month.
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Time -1
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Participant Recruitment (1) - Agree to Research Contact
Time Frame: Time -1
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Criterion for success: 90% of clients referred to LTP-B to agree to be contacted for purposes of research.
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Time -1
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Participant Recruitment (2) - Participants Enrolled
Time Frame: Time -1
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Criterion for success: 90% of clients participating in LTP-B to enroll in the research study.
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Time -1
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Participant Recruitment (3) Families Enrolled Per Month
Time Frame: Time -1
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Criterion for success: 1.8 families enrolled per month.
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Time -1
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Adherence to Intervention
Time Frame: Times 1, 2, 3
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Criterion for success: 90% of participants to complete all three main LTP-B sessions (Family assessment, videofeedback, check in)
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Times 1, 2, 3
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Retention: Post-Intervention
Time Frame: Time 3
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Criterion for success: 90% of participants to remain in study until the end of post-intervention assessment.
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Time 3
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Retention: Follow-Up
Time Frame: Time 4
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Criterion for success: 80% of participants to remain in study until the end of follow-up assessment.
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Time 4
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Retention: Brief Surveys
Time Frame: Time 1, 2, 5
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Criterion for success: 80% of participants to complete all brief surveys.
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Time 1, 2, 5
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Acceptability
Time Frame: Time 3, 4
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Criterion for success: 80 % of participants reporting at least "agree" on indicators of attitude, burden, perceived effectiveness, and ethicality on an Implementation Acceptability Scale.
Minimum score=7, maximum scores=35.
Higher scores correspond to better outcomes.
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Time 3, 4
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Descriptive (no criterion for success): Behavioral Coding of Family Interactions (Frascarolo et al., 2018)
Time Frame: Week 1
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Family interactions will be behaviourally coded by trained coders based on the LTP Assessments (initial family assessment), using previously validated approaches (e.g., Frasarolo et al., 2018).
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Week 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brief Dyadic Adjustment
Time Frame: Time 0, 1, 2, 3, 4, 5
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Using the Brief Dyadic Adjustment Scale (DAS-4).
Minimum score= 0, maximum score=21.
Higher scores correspond to better outcomes.
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Time 0, 1, 2, 3, 4, 5
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Coparenting Relationship Quality
Time Frame: Time 0, 3, 4
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Using the Brief Coparenting Relationship Scale (Feinberg et al., 2012).
Minimum score=0, maximum score=84.
Higher scores correspond to better outcomes.
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Time 0, 3, 4
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Brief Coparenting Relationship Quality
Time Frame: Time 1, 2, 5
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Using the Subset of Brief Coparenting Relationship Quality Scale (Feinberg et al., 2012).
Minimum score=0, maximum score=36.
Higher scores correspond to better outcomes.
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Time 1, 2, 5
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Parent-Child Positivity
Time Frame: Time 0, 3, 4
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Using the 5-item parent-reported positivity subscale of the Parenting Practices Scale.
Minimum score=5, maximum score=25.
Higher scores correspond to better outcomes.
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Time 0, 3, 4
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Parent-Child Negativity
Time Frame: Time 0, 3, 4
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Using the 5-item parent-reported negativity subscale of the Parenting Practices Scale.
Minimum score=5, maximum score=25.
Higher scores correspond to worse outcomes.
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Time 0, 3, 4
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Sibling Relations
Time Frame: Time 0, 3, 4
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Using Parental Expectations and Perceptions of Children's Sibling Relationship Questionnaire (PEPC-SRQ).
Minimum score=8 , maximum score=40.
Higher scores correspond to better outcomes.
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Time 0, 3, 4
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Whole Family Functioning
Time Frame: Time 0, 3, 4
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Using 6-item Family Assessment Device (FAD).
Minimum score=5, maximum score=20.
Higher scores correspond to worse outcomes.
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Time 0, 3, 4
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Parent Mental Health
Time Frame: Time 0, 3, 4
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Using the Kessler Psychological Distress Scale (K10).
Minimum score=10, maximum score=50.
Higher scores correspond to worse outcomes.
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Time 0, 3, 4
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Brief Parent Mental Health
Time Frame: Time 1, 2, 5
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Using the Kessler Psychological Distress Scale (K6).
Minimum score=6, maximum score=30.
Higher scores correspond to worse outcomes.
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Time 1, 2, 5
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Child Emotional and Behavioural Problems (1) - (Children Ages 18 months to 3 years 11 months)
Time Frame: Time 0, 3, 4
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Scores will be standardized within each age group and used as a single outcome variable. The Preschool Pediatric Symptom Checklist (PPSC-17): Minimum score=0, maximum score=36. Higher scores correspond to worse outcomes. |
Time 0, 3, 4
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Child Emotional and Behavioural Problems (2) - (Children Ages 4 to 18 years)
Time Frame: Time 0, 3, 4
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Scores will be standardized within each age group and used as a single outcome variable. The Pediatric Symptom Checklist (PSC-17). Minimum score=0, maximum score=34. Higher scores correspond to worse outcomes. |
Time 0, 3, 4
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Examine Therapy Sessions
Time Frame: Weeks 1, 2, 3
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Examine content and process of all therapy sessions (including therapist and client behaviours) qualitatively for a select number of 'successful' and 'unsuccessful' cases, using a pragmatic case-series analysis (e.g., Liekmeier et al., 2021)
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Weeks 1, 2, 3
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Heather Prime, PhD, York University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-050
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
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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