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

Not Applicable

• Conditions: Parent-Child Relations; Mental Health Issue; Family Relations; Behavioral Problem; Internet-Based Intervention
• Interventions: Behavioral: Lausanne Trialogue Play Brief

• Registration Number: NCT05356247
• Lead Sponsor: York University

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.

Study Timeline

• Study First Submitted: 2022-03-22
• Study First Submitted QC: 2022-04-29
• Study First Posted: 2022-05-02
• Study Start: 2022-06-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-11
• Last Update Posted: 2022-07-12
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LTP-B Intervention	Lausanne Trialogue Play Brief	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.

Primary Outcome Measures

Name	Time	Method
COVID-19-related Family Stressors	Time 0, 3	Descriptive (no criterion for success): Family Stressor Scale. Minimum score=16, maximum score=48. Higher scores correspond to worse outcomes.
Research-Clinical Communication (1) - Clients Referred to LTP-B	Time -1	Criterion for success: 95% of clients referred to LTP-B to be asked permission to be contacted by the research team.
Clinical Service Flow (2) - Service Provision	Time -1	Criterion for success: 2 families to be seen by the LTP-B team per month.
Participant Recruitment (2) - Participants Enrolled	Time -1	Criterion for success: 90% of clients participating in LTP-B to enroll in the research study.
Acceptability	Time 3, 4	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.
Form Research-Clinical Partnership (1) - Clinical-Research Meetings	Time -1 to end of study	Criterion for success: Meet once monthly throughout the course of the study.
Research-Clinical Communication (4) - Videos Shared	Time 1, 2, 3	Criterion for success: 95% of participant videos (previously consented) to be successfully shared with the research team.
Participant Recruitment (1) - Agree to Research Contact	Time -1	Criterion for success: 90% of clients referred to LTP-B to agree to be contacted for purposes of research.
Participant Recruitment (3) Families Enrolled Per Month	Time -1	Criterion for success: 1.8 families enrolled per month.
Retention: Brief Surveys	Time 1, 2, 5	Criterion for success: 80% of participants to complete all brief surveys.
COVID-19-related Family Positive Adaptation	Time 0, 3	Descriptive (no criterion for success): COVID-19 Family Positive Adaptation Scale. Minimum score=14, maximum score=42. Higher scores correspond to better outcomes.
Form Research-Clinical Partnership (2) - Protocol Development - a	Time -1	Criterion for success: Administrative approval from SKCCMH for study (via approval of ethics approval).
Adherence to Intervention	Times 1, 2, 3	Criterion for success: 90% of participants to complete all three main LTP-B sessions (Family assessment, videofeedback, check in)
Retention: Follow-Up	Time 4	Criterion for success: 80% of participants to remain in study until the end of follow-up assessment.
Form Research-Clinical Partnership (3) - Protocol Development - b	Time -1	Criterion for success: Submission of protocol for registration to clinicaltrials.gov and/or journal publications.
Research-Clinical Communication (2) - Clients Transferred to Research Team	Time -1	Criterion for success: 95% of clients that agree to research are transferred to the research team for contact.
Descriptive (no criterion for success): Behavioral Coding of Family Interactions (Frascarolo et al., 2018)	Week 1	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).
Therapeutic Alliance	Time 1, 2, 3, 5	Descriptive (no criterion for success): Working Alliance Inventory-Short Revised (WAI-SR). Minimum score=12, maximum score=60. Higher scores correspond to better outcomes.
Research-Clinical Communication (3) - Clinical Visits Shared	Time -1 to end of study	Criterion for success: 95% of participants' scheduled clinical visits to be shared with the research team.
Clinical Service Flow (1) - Clients Referred	Time -1	Criterion for success: 3 families to be referred to the LTP-B per month.
Retention: Post-Intervention	Time 3	Criterion for success: 90% of participants to remain in study until the end of post-intervention assessment.

Secondary Outcome Measures

Name	Time	Method
Coparenting Relationship Quality	Time 0, 3, 4	Using the Brief Coparenting Relationship Scale (Feinberg et al., 2012). Minimum score=0, maximum score=84. Higher scores correspond to better outcomes.
Parent-Child Positivity	Time 0, 3, 4	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.
Child Emotional and Behavioural Problems (2) - (Children Ages 4 to 18 years)	Time 0, 3, 4	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.
Brief Dyadic Adjustment	Time 0, 1, 2, 3, 4, 5	Using the Brief Dyadic Adjustment Scale (DAS-4). Minimum score= 0, maximum score=21. Higher scores correspond to better outcomes.
Brief Coparenting Relationship Quality	Time 1, 2, 5	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 Negativity	Time 0, 3, 4	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.
Whole Family Functioning	Time 0, 3, 4	Using 6-item Family Assessment Device (FAD). Minimum score=5, maximum score=20. Higher scores correspond to worse outcomes.
Parent Mental Health	Time 0, 3, 4	Using the Kessler Psychological Distress Scale (K10). Minimum score=10, maximum score=50. Higher scores correspond to worse outcomes.
Sibling Relations	Time 0, 3, 4	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.
Brief Parent Mental Health	Time 1, 2, 5	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)	Time 0, 3, 4	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.
Examine Therapy Sessions	Weeks 1, 2, 3	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)

Trial Locations

Locations (1)

York University; 🇨🇦 Toronto, Ontario, Canada