Lausanne Trialogue Paradigm - Brief: A Family Systems Model to Address Child Mental Health in a Community Mental Health Setting
试验速览
- 阶段
- 不适用
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Research-Clinical Communication (1) - Clients Referred to LTP-B
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Months 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •No exclusion criteria beyond what is standard for the clinical service at SKCCMH.
结局指标
主要结局
Research-Clinical Communication (1) - Clients Referred to LTP-B
时间窗: 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
时间窗: Time -1
Criterion for success: 2 families to be seen by the LTP-B team per month.
Participant Recruitment (2) - Participants Enrolled
时间窗: Time -1
Criterion for success: 90% of clients participating in LTP-B to enroll in the research study.
COVID-19-related Family Stressors
时间窗: Time 0, 3
Descriptive (no criterion for success): Family Stressor Scale. Minimum score=16, maximum score=48. Higher scores correspond to worse outcomes.
Acceptability
时间窗: 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
时间窗: Time -1 to end of study
Criterion for success: Meet once monthly throughout the course of the study.
Research-Clinical Communication (4) - Videos Shared
时间窗: 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
时间窗: 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
时间窗: Time -1
Criterion for success: 1.8 families enrolled per month.
Retention: Brief Surveys
时间窗: Time 1, 2, 5
Criterion for success: 80% of participants to complete all brief surveys.
COVID-19-related Family Positive Adaptation
时间窗: 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
时间窗: Time -1
Criterion for success: Administrative approval from SKCCMH for study (via approval of ethics approval).
Adherence to Intervention
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Time -1
Criterion for success: 3 families to be referred to the LTP-B per month.
Retention: Post-Intervention
时间窗: Time 3
Criterion for success: 90% of participants to remain in study until the end of post-intervention assessment.
次要结局
- Coparenting Relationship Quality(Time 0, 3, 4)
- Parent-Child Positivity(Time 0, 3, 4)
- Child Emotional and Behavioural Problems (2) - (Children Ages 4 to 18 years)(Time 0, 3, 4)
- Brief Dyadic Adjustment(Time 0, 1, 2, 3, 4, 5)
- Brief Coparenting Relationship Quality(Time 1, 2, 5)
- Parent-Child Negativity(Time 0, 3, 4)
- Whole Family Functioning(Time 0, 3, 4)
- Parent Mental Health(Time 0, 3, 4)
- Sibling Relations(Time 0, 3, 4)
- Brief Parent Mental Health(Time 1, 2, 5)
- Child Emotional and Behavioural Problems (1) - (Children Ages 18 months to 3 years 11 months)(Time 0, 3, 4)
- Examine Therapy Sessions(Weeks 1, 2, 3)
研究者
Heather Prime
Assistant Professor
York University