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

NCT05356247 | Unknown

• 1 other identifier: 2022-050
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (21)

• 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

• 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

• 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

• 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

• Form Research-Clinical Partnership (2) - Protocol Development - a

  Criterion for success: Administrative approval from SKCCMH for study (via approval of ethics approval).

  Time -1

• 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

• 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

• 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

• 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

• 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

• Clinical Service Flow (1) - Clients Referred

  Criterion for success: 3 families to be referred to the LTP-B per month.

  Time -1

• Clinical Service Flow (2) - Service Provision

  Criterion for success: 2 families to be seen by the LTP-B team per month.

  Time -1

• 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

• Participant Recruitment (2) - Participants Enrolled

  Criterion for success: 90% of clients participating in LTP-B to enroll in the research study.

  Time -1

• Participant Recruitment (3) Families Enrolled Per Month

  Criterion for success: 1.8 families enrolled per month.

  Time -1

• 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

• Retention: Post-Intervention

  Criterion for success: 90% of participants to remain in study until the end of post-intervention assessment.

  Time 3

• Retention: Follow-Up

  Criterion for success: 80% of participants to remain in study until the end of follow-up assessment.

  Time 4

• Retention: Brief Surveys

  Criterion for success: 80% of participants to complete all brief surveys.

  Time 1, 2, 5

• 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

• 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 Outcomes (12)

• Brief Dyadic Adjustment

  Time 0, 1, 2, 3, 4, 5

• Coparenting Relationship Quality

  Time 0, 3, 4

• Brief Coparenting Relationship Quality

  Time 1, 2, 5

• Parent-Child Positivity

  Time 0, 3, 4

• Parent-Child Negativity

  Time 0, 3, 4

Study Arms (1)

LTP-B Intervention

EXPERIMENTAL

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.

Behavioral: Lausanne Trialogue Play Brief

Interventions

Lausanne Trialogue Play Brief BEHAVIORAL

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.

Also known as: LTP-B

LTP-B Intervention

Eligibility Criteria

• Age: 0 Months - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• York University: lead
• University of Lausanne: collaborator
• SickKids Centre for Community Mental Health (SKCCMH): collaborator

Study Sites (1)

York University

Toronto, Ontario, M3J 1P3, Canada

RECRUITING

MeSH Terms

Conditions

Problem Behavior

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Child Behavior

Study Officials

• Heather Prime, PhD

  York University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather Prime, PhD

CONTACT

4168197331; hprime@yorku.com

Diane Philipps, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: May 2, 2022
• Study Start: June 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: July 12, 2022

Record last verified: 2022-07

Locations

CA (1)