Clinical trial NCT05356247: Lausanne Trialogue Paradigm - Brief: A Family Model for Child Mental Health in a Community Setting
Official title: Lausanne Trialogue Paradigm - Brief: A Family Systems Model to Address Child Mental Health in a Community Mental Health Setting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: York University
Sponsor class: OTHER
Collaborators: name: University of Lausanne
name: SickKids Centre for Community Mental Health (SKCCMH)
First posted: 2022-05-02
Enrollment: 25
Sex: ALL
Minimum age (years): 0
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: COVID-19-related Family Stressors
timeFrame: Time 0, 3
measure: COVID-19-related Family Positive Adaptation
timeFrame: Time 0, 3
measure: Therapeutic Alliance
timeFrame: Time 1, 2, 3, 5
measure: Form Research-Clinical Partnership (1) - Clinical-Research Meetings
timeFrame: Time -1 to end of study
measure: Form Research-Clinical Partnership (2) - Protocol Development - a
timeFrame: Time -1
measure: Form Research-Clinical Partnership (3) - Protocol Development - b
timeFrame: Time -1
measure: Research-Clinical Communication (1) - Clients Referred to LTP-B
timeFrame: Time -1
measure: Research-Clinical Communication (2) - Clients Transferred to Research Team
timeFrame: Time -1
measure: Research-Clinical Communication (3) - Clinical Visits Shared
timeFrame: Time -1 to end of study
measure: Research-Clinical Communication (4) - Videos Shared
timeFrame: Time 1, 2, 3
measure: Clinical Service Flow (1) - Clients Referred
timeFrame: Time -1
measure: Clinical Service Flow (2) - Service Provision
timeFrame: Time -1
measure: Participant Recruitment (1) - Agree to Research Contact
timeFrame: Time -1
measure: Participant Recruitment (2) - Participants Enrolled
timeFrame: Time -1
measure: Participant Recruitment (3) Families Enrolled Per Month
timeFrame: Time -1
measure: Adherence to Intervention
timeFrame: Times 1, 2, 3
measure: Retention: Post-Intervention
timeFrame: Time 3
measure: Retention: Follow-Up
timeFrame: Time 4
measure: Retention: Brief Surveys
timeFrame: Time 1, 2, 5
measure: Acceptability
timeFrame: Time 3, 4
measure: Descriptive (no criterion for success): Behavioral Coding of Family Interactions (Frascarolo et al., 2018)
timeFrame: Week 1
Secondary outcomes:
measure: Brief Dyadic Adjustment
timeFrame: Time 0, 1, 2, 3, 4, 5
measure: Coparenting Relationship Quality
timeFrame: Time 0, 3, 4
measure: Brief Coparenting Relationship Quality
timeFrame: Time 1, 2, 5
measure: Parent-Child Positivity
timeFrame: Time 0, 3, 4
measure: Parent-Child Negativity
timeFrame: Time 0, 3, 4
measure: Sibling Relations
timeFrame: Time 0, 3, 4
measure: Whole Family Functioning
timeFrame: Time 0, 3, 4
measure: Parent Mental Health
timeFrame: Time 0, 3, 4
measure: Brief Parent Mental Health
timeFrame: Time 1, 2, 5
measure: Child Emotional and Behavioural Problems (1) - (Children Ages 18 months to 3 years 11 months)
timeFrame: Time 0, 3, 4
measure: Child Emotional and Behavioural Problems (2) - (Children Ages 4 to 18 years)
timeFrame: Time 0, 3, 4
measure: Examine Therapy Sessions
timeFrame: Weeks 1, 2, 3
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: York University
state: Ontario
Study officials:
affiliation: York University
name: Heather Prime, PhD
role: PRINCIPAL_INVESTIGATOR
References: