Lausanne Trialogue Paradigm - Brief: A Family Model for Child Mental Health in a Community Setting

Mental Health Issue Clinical Trial

— LTP-B  

Official title:

Lausanne Trialogue Paradigm - Brief: A Family Systems Model to Address Child Mental Health in a Community Mental Health Setting

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05356247
• Other study ID #: 2022-050
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: July 2022
• Source: York University
• Contact: Heather Prime, PhD
• Phone: 4168197331
• Email: hprime[@]yorku.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Behavioral Problem
• Family Relations
• Internet-Based Intervention
• Mental Health Issue
• Parent-Child Relations
• Problem Behavior

Intervention

Behavioral:
• Lausanne Trialogue Play Brief
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.

Locations

Country	Name	City	State
Canada	York University	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
York University	SickKids Centre for Community Mental Health (SKCCMH), University of Lausanne

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Time 0, 3
Primary	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.	Time 0, 3
Primary	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.	Time 1, 2, 3, 5
Primary	Form Research-Clinical Partnership (1) - Clinical-Research Meetings	Criterion for success: Meet once monthly throughout the course of the study.	Time -1 to end of study
Primary	Form Research-Clinical Partnership (2) - Protocol Development - a	Criterion for success: Administrative approval from SKCCMH for study (via approval of ethics approval).	Time -1
Primary	Form Research-Clinical Partnership (3) - Protocol Development - b	Criterion for success: Submission of protocol for registration to clinicaltrials.gov and/or journal publications.	Time -1
Primary	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.	Time -1
Primary	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.	Time -1
Primary	Research-Clinical Communication (3) - Clinical Visits Shared	Criterion for success: 95% of participants' scheduled clinical visits to be shared with the research team.	Time -1 to end of study
Primary	Research-Clinical Communication (4) - Videos Shared	Criterion for success: 95% of participant videos (previously consented) to be successfully shared with the research team.	Time 1, 2, 3
Primary	Clinical Service Flow (1) - Clients Referred	Criterion for success: 3 families to be referred to the LTP-B per month.	Time -1
Primary	Clinical Service Flow (2) - Service Provision	Criterion for success: 2 families to be seen by the LTP-B team per month.	Time -1
Primary	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.	Time -1
Primary	Participant Recruitment (2) - Participants Enrolled	Criterion for success: 90% of clients participating in LTP-B to enroll in the research study.	Time -1
Primary	Participant Recruitment (3) Families Enrolled Per Month	Criterion for success: 1.8 families enrolled per month.	Time -1
Primary	Adherence to Intervention	Criterion for success: 90% of participants to complete all three main LTP-B sessions (Family assessment, videofeedback, check in)	Times 1, 2, 3
Primary	Retention: Post-Intervention	Criterion for success: 90% of participants to remain in study until the end of post-intervention assessment.	Time 3
Primary	Retention: Follow-Up	Criterion for success: 80% of participants to remain in study until the end of follow-up assessment.	Time 4
Primary	Retention: Brief Surveys	Criterion for success: 80% of participants to complete all brief surveys.	Time 1, 2, 5
Primary	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.	Time 3, 4
Primary	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).	Week 1
Secondary	Brief Dyadic Adjustment	Using the Brief Dyadic Adjustment Scale (DAS-4). Minimum score= 0, maximum score=21. Higher scores correspond to better outcomes.	Time 0, 1, 2, 3, 4, 5
Secondary	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.	Time 0, 3, 4
Secondary	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.	Time 1, 2, 5
Secondary	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.	Time 0, 3, 4
Secondary	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.	Time 0, 3, 4
Secondary	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.	Time 0, 3, 4
Secondary	Whole Family Functioning	Using 6-item Family Assessment Device (FAD). Minimum score=5, maximum score=20. Higher scores correspond to worse outcomes.	Time 0, 3, 4
Secondary	Parent Mental Health	Using the Kessler Psychological Distress Scale (K10). Minimum score=10, maximum score=50. Higher scores correspond to worse outcomes.	Time 0, 3, 4
Secondary	Brief Parent Mental Health	Using the Kessler Psychological Distress Scale (K6). Minimum score=6, maximum score=30. Higher scores correspond to worse outcomes.	Time 1, 2, 5
Secondary	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.	Time 0, 3, 4
Secondary	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.	Time 0, 3, 4
Secondary	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)	Weeks 1, 2, 3