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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05356247
Other study ID # 2022-050
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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