Lausanne Trialogue Paradigm - Brief: A Family Model for Child Mental Health in a Community Setting (LTP-B)
Primary Purpose
Parent-Child Relations, Family Relations, Internet-Based Intervention
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Lausanne Trialogue Play Brief
Sponsored by
About this trial
This is an interventional treatment trial for Parent-Child Relations focused on measuring Child Mental Health, Family Systems, Coparenting, Single arm pre-post design, COVID-19 Family Recovery
Eligibility Criteria
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.
Sites / Locations
- York UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LTP-B Intervention
Arm Description
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.
Outcomes
Primary Outcome Measures
COVID-19-related Family Stressors
Descriptive (no criterion for success): Family Stressor Scale. Minimum score=16, maximum score=48. Higher scores correspond to worse outcomes.
COVID-19-related Family Positive Adaptation
Descriptive (no criterion for success): COVID-19 Family Positive Adaptation Scale. Minimum score=14, maximum score=42. Higher scores correspond to better outcomes.
Therapeutic Alliance
Descriptive (no criterion for success): Working Alliance Inventory-Short Revised (WAI-SR). Minimum score=12, maximum score=60. Higher scores correspond to better outcomes.
Form Research-Clinical Partnership (1) - Clinical-Research Meetings
Criterion for success: Meet once monthly throughout the course of the study.
Form Research-Clinical Partnership (2) - Protocol Development - a
Criterion for success: Administrative approval from SKCCMH for study (via approval of ethics approval).
Form Research-Clinical Partnership (3) - Protocol Development - b
Criterion for success: Submission of protocol for registration to clinicaltrials.gov and/or journal publications.
Research-Clinical Communication (1) - Clients Referred to LTP-B
Criterion for success: 95% of clients referred to LTP-B to be asked permission to be contacted by the research team.
Research-Clinical Communication (2) - Clients Transferred to Research Team
Criterion for success: 95% of clients that agree to research are transferred to the research team for contact.
Research-Clinical Communication (3) - Clinical Visits Shared
Criterion for success: 95% of participants' scheduled clinical visits to be shared with the research team.
Research-Clinical Communication (4) - Videos Shared
Criterion for success: 95% of participant videos (previously consented) to be successfully shared with the research team.
Clinical Service Flow (1) - Clients Referred
Criterion for success: 3 families to be referred to the LTP-B per month.
Clinical Service Flow (2) - Service Provision
Criterion for success: 2 families to be seen by the LTP-B team per month.
Participant Recruitment (1) - Agree to Research Contact
Criterion for success: 90% of clients referred to LTP-B to agree to be contacted for purposes of research.
Participant Recruitment (2) - Participants Enrolled
Criterion for success: 90% of clients participating in LTP-B to enroll in the research study.
Participant Recruitment (3) Families Enrolled Per Month
Criterion for success: 1.8 families enrolled per month.
Adherence to Intervention
Criterion for success: 90% of participants to complete all three main LTP-B sessions (Family assessment, videofeedback, check in)
Retention: Post-Intervention
Criterion for success: 90% of participants to remain in study until the end of post-intervention assessment.
Retention: Follow-Up
Criterion for success: 80% of participants to remain in study until the end of follow-up assessment.
Retention: Brief Surveys
Criterion for success: 80% of participants to complete all brief surveys.
Acceptability
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.
Descriptive (no criterion for success): Behavioral Coding of Family Interactions (Frascarolo et al., 2018)
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).
Secondary Outcome Measures
Brief Dyadic Adjustment
Using the Brief Dyadic Adjustment Scale (DAS-4). Minimum score= 0, maximum score=21. Higher scores correspond to better outcomes.
Coparenting Relationship Quality
Using the Brief Coparenting Relationship Scale (Feinberg et al., 2012). Minimum score=0, maximum score=84. Higher scores correspond to better outcomes.
Brief Coparenting Relationship Quality
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.
Parent-Child Positivity
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.
Parent-Child Negativity
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.
Sibling Relations
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.
Whole Family Functioning
Using 6-item Family Assessment Device (FAD). Minimum score=5, maximum score=20. Higher scores correspond to worse outcomes.
Parent Mental Health
Using the Kessler Psychological Distress Scale (K10). Minimum score=10, maximum score=50. Higher scores correspond to worse outcomes.
Brief Parent Mental Health
Using the Kessler Psychological Distress Scale (K6). Minimum score=6, maximum score=30. Higher scores correspond to worse outcomes.
Child Emotional and Behavioural Problems (1) - (Children Ages 18 months to 3 years 11 months)
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.
Child Emotional and Behavioural Problems (2) - (Children Ages 4 to 18 years)
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.
Examine Therapy Sessions
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)
Full Information
NCT ID
NCT05356247
First Posted
March 22, 2022
Last Updated
July 11, 2022
Sponsor
York University
Collaborators
University of Lausanne, SickKids Centre for Community Mental Health (SKCCMH)
1. Study Identification
Unique Protocol Identification Number
NCT05356247
Brief Title
Lausanne Trialogue Paradigm - Brief: A Family Model for Child Mental Health in a Community Setting
Acronym
LTP-B
Official Title
Lausanne Trialogue Paradigm - Brief: A Family Systems Model to Address Child Mental Health in a Community Mental Health Setting
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
York University
Collaborators
University of Lausanne, SickKids Centre for Community Mental Health (SKCCMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The current study is a feasibility pilot of the Lausanne Trialogue Play paradigm Intervention - Brief (LTP-Brief), a family systems therapy implemented in a community mental health setting. We will study the ultrabrief, virtual therapy to assess the feasibility of a future pilot RCT. Feasibility metrics include resource, scientific, and management considerations, as well as an examination of pre-post change in future child and family outcomes of interest.
Detailed Description
COVID-19 represents an acute crisis to children's mental health, with potential for long-term consequences. There is evidence for elevated mental health symptomatology in children since the start of the pandemic, with the emergence of stress-related disorders and the exacerbation of pre-existing disorders. Indeed, the pandemic has had detrimental effects on family life due to widespread job loss and financial insecurity, and increases to parental psychological distress, mental illness, and substance use. Social consequences of COVID-19 are expected to have cascading negative effects on child mental health symptoms. Thus, a COVID-19 family recovery program is critically needed, both during and after the pandemic, to manage the current mental health crisis in children and create cascading and sustainable effects for lifelong physical and mental health. The main goal of the the current study is to investigate feasibility of a future pilot and/or main RCT of a brief, virtual mental health treatment program for children and families designed to optimize reach of services. Specifically, the Lausanne Trialogue Play paradigm assessment is a semi-structured assessment of whole family interactions, with emphasis on the co-parenting relationship, which has been used extensively in research settings for assessment and consultative purposes. The current study will assess the feasibility of using the LTP in an assessment-as-treatment model. This brief treatment program, called the LTP-Brief intervention (LTP-B) will consist of a family play assessment (including an LTP assessment) with video feedback to caregivers as a method for promoting change in family interaction patterns. By targeting change across the family system, rather than focusing on specific child mental health symptoms directly, the model addresses upheaval of family life during COVID-19 and has potential to create sustainable improvements in family well-being within a short period of time.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parent-Child Relations, Family Relations, Internet-Based Intervention, Mental Health Issue, Behavioral Problem
Keywords
Child Mental Health, Family Systems, Coparenting, Single arm pre-post design, COVID-19 Family Recovery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LTP-B Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Lausanne Trialogue Play Brief
Other Intervention Name(s)
LTP-B
Intervention Description
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.
Primary Outcome Measure Information:
Title
COVID-19-related Family Stressors
Description
Descriptive (no criterion for success): Family Stressor Scale. Minimum score=16, maximum score=48. Higher scores correspond to worse outcomes.
Time Frame
Time 0, 3
Title
COVID-19-related Family Positive Adaptation
Description
Descriptive (no criterion for success): COVID-19 Family Positive Adaptation Scale. Minimum score=14, maximum score=42. Higher scores correspond to better outcomes.
Time Frame
Time 0, 3
Title
Therapeutic Alliance
Description
Descriptive (no criterion for success): Working Alliance Inventory-Short Revised (WAI-SR). Minimum score=12, maximum score=60. Higher scores correspond to better outcomes.
Time Frame
Time 1, 2, 3, 5
Title
Form Research-Clinical Partnership (1) - Clinical-Research Meetings
Description
Criterion for success: Meet once monthly throughout the course of the study.
Time Frame
Time -1 to end of study
Title
Form Research-Clinical Partnership (2) - Protocol Development - a
Description
Criterion for success: Administrative approval from SKCCMH for study (via approval of ethics approval).
Time Frame
Time -1
Title
Form Research-Clinical Partnership (3) - Protocol Development - b
Description
Criterion for success: Submission of protocol for registration to clinicaltrials.gov and/or journal publications.
Time Frame
Time -1
Title
Research-Clinical Communication (1) - Clients Referred to LTP-B
Description
Criterion for success: 95% of clients referred to LTP-B to be asked permission to be contacted by the research team.
Time Frame
Time -1
Title
Research-Clinical Communication (2) - Clients Transferred to Research Team
Description
Criterion for success: 95% of clients that agree to research are transferred to the research team for contact.
Time Frame
Time -1
Title
Research-Clinical Communication (3) - Clinical Visits Shared
Description
Criterion for success: 95% of participants' scheduled clinical visits to be shared with the research team.
Time Frame
Time -1 to end of study
Title
Research-Clinical Communication (4) - Videos Shared
Description
Criterion for success: 95% of participant videos (previously consented) to be successfully shared with the research team.
Time Frame
Time 1, 2, 3
Title
Clinical Service Flow (1) - Clients Referred
Description
Criterion for success: 3 families to be referred to the LTP-B per month.
Time Frame
Time -1
Title
Clinical Service Flow (2) - Service Provision
Description
Criterion for success: 2 families to be seen by the LTP-B team per month.
Time Frame
Time -1
Title
Participant Recruitment (1) - Agree to Research Contact
Description
Criterion for success: 90% of clients referred to LTP-B to agree to be contacted for purposes of research.
Time Frame
Time -1
Title
Participant Recruitment (2) - Participants Enrolled
Description
Criterion for success: 90% of clients participating in LTP-B to enroll in the research study.
Time Frame
Time -1
Title
Participant Recruitment (3) Families Enrolled Per Month
Description
Criterion for success: 1.8 families enrolled per month.
Time Frame
Time -1
Title
Adherence to Intervention
Description
Criterion for success: 90% of participants to complete all three main LTP-B sessions (Family assessment, videofeedback, check in)
Time Frame
Times 1, 2, 3
Title
Retention: Post-Intervention
Description
Criterion for success: 90% of participants to remain in study until the end of post-intervention assessment.
Time Frame
Time 3
Title
Retention: Follow-Up
Description
Criterion for success: 80% of participants to remain in study until the end of follow-up assessment.
Time Frame
Time 4
Title
Retention: Brief Surveys
Description
Criterion for success: 80% of participants to complete all brief surveys.
Time Frame
Time 1, 2, 5
Title
Acceptability
Description
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.
Time Frame
Time 3, 4
Title
Descriptive (no criterion for success): Behavioral Coding of Family Interactions (Frascarolo et al., 2018)
Description
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).
Time Frame
Week 1
Secondary Outcome Measure Information:
Title
Brief Dyadic Adjustment
Description
Using the Brief Dyadic Adjustment Scale (DAS-4). Minimum score= 0, maximum score=21. Higher scores correspond to better outcomes.
Time Frame
Time 0, 1, 2, 3, 4, 5
Title
Coparenting Relationship Quality
Description
Using the Brief Coparenting Relationship Scale (Feinberg et al., 2012). Minimum score=0, maximum score=84. Higher scores correspond to better outcomes.
Time Frame
Time 0, 3, 4
Title
Brief Coparenting Relationship Quality
Description
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.
Time Frame
Time 1, 2, 5
Title
Parent-Child Positivity
Description
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.
Time Frame
Time 0, 3, 4
Title
Parent-Child Negativity
Description
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.
Time Frame
Time 0, 3, 4
Title
Sibling Relations
Description
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.
Time Frame
Time 0, 3, 4
Title
Whole Family Functioning
Description
Using 6-item Family Assessment Device (FAD). Minimum score=5, maximum score=20. Higher scores correspond to worse outcomes.
Time Frame
Time 0, 3, 4
Title
Parent Mental Health
Description
Using the Kessler Psychological Distress Scale (K10). Minimum score=10, maximum score=50. Higher scores correspond to worse outcomes.
Time Frame
Time 0, 3, 4
Title
Brief Parent Mental Health
Description
Using the Kessler Psychological Distress Scale (K6). Minimum score=6, maximum score=30. Higher scores correspond to worse outcomes.
Time Frame
Time 1, 2, 5
Title
Child Emotional and Behavioural Problems (1) - (Children Ages 18 months to 3 years 11 months)
Description
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 Frame
Time 0, 3, 4
Title
Child Emotional and Behavioural Problems (2) - (Children Ages 4 to 18 years)
Description
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 Frame
Time 0, 3, 4
Title
Examine Therapy Sessions
Description
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)
Time Frame
Weeks 1, 2, 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Months
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heather Prime, PhD
Phone
4168197331
Email
hprime@yorku.com
First Name & Middle Initial & Last Name or Official Title & Degree
Diane Philipps, PhD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Prime, PhD
Organizational Affiliation
York University
Official's Role
Principal Investigator
Facility Information:
Facility Name
York University
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3J 1P3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Prime, PhD
Email
hprime@yorku.ca
First Name & Middle Initial & Last Name & Degree
Heather Prime, PhD
First Name & Middle Initial & Last Name & Degree
Diane Philipps, PhD
First Name & Middle Initial & Last Name & Degree
Joelle Darwiche, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Lausanne Trialogue Paradigm - Brief: A Family Model for Child Mental Health in a Community Setting
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