Mental Health Issue Clinical Trial
— LTP-BOfficial title:
Lausanne Trialogue Paradigm - Brief: A Family Systems Model to Address Child Mental Health in a Community Mental Health Setting
Verified date | July 2022 |
Source | York University |
Contact | Heather Prime, PhD |
Phone | 4168197331 |
hprime[@]yorku.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Canada | York University | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
York University | SickKids Centre for Community Mental Health (SKCCMH), University of Lausanne |
Canada,
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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