Mechanisms and Outcomes of Children and Adolescent Psychotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30,000
- 试验地点
- 1
- 主要终点
- Health Services Utilization
研究概览
简要总结
Since October 7th 2023, Israel's population has been forced to engage in a multi-regional war which affected most of the citizens of Israel. One of the most sensitive populations to be affected by the horrifying events are children and adolescents. In a meta-analysis summarizing the results of 20 studies encompassing a total of 26,302 children and adolescents, the authors reported a significant association between the degree of exposure to traumatic events and psychological distress. Furthermore, a recent study conducted in Ukraine during Russia's invasion indicated an increase in internalizing symptoms among children and adolescents, as reported by parents. Nevertheless, to date, no study has evaluated the extent of distress, and overall mental and physical consequences among children and their parents, in the context of the October 7th events.
One of the main routes to provide care to children and adolescents inflicted by the consequences of war is through psychotherapy. Although psychotherapy is considered an effective treatment for children and adolescents, studies indicate that dropout rates among this population is as high as 45%. Several predictors were previously offered to be associated with children and adolescents' dropout and psychotherapy outcomes. These predictors can be broadly categorized into two conceptual dimensions. The first is pre-treatment variables that are associated with both children and their parents, such as demographics (i.e., ethnicity, gender, age), diagnosis (including classification and co-morbidity), symptom severity, family characteristics, and parental problems and difficulties. The second dimension is related to within-therapy factors, such as patients' expectations and the quality of mutual work with the therapist. Nonetheless, to date, no systematic study has assessed pre-treatment and within-treatment predictors of dropout and outcome in general or in the context of political conflict.
Research Objectives
This study aims to address current gaps in the literature by assessing the effects of October 7th events on parents, children, and adolescents. Furthermore, the study aims to assess the effects of psychotherapy provided in the settings of crisis intervention and treatment as usual in outpatient clinics to children following the war. Research objectives will be addressed using two methodological approaches: a retrospective big-data strategy exploration, and a prospective assessment of ongoing psychotherapies. Based on the reviewed literature, the following research hypotheses will be investigated:
- Parental psychopathology will mediate the association between traumatic exposure during war and their child's mental and physical health.
- Dropout rates from psychotherapy in Israel will be found as similar to those reported in a previous meta-analysis (~45%).
- Within-treatment variables will have a stronger association with dropout risk and outcome, compared to pre-treatment variables.
详细描述
Study Sample
Phase I: Retrospective big-data study To assess October 7th implications, data derived from Clalit Health Services CHS databases will be used to assess October 7th's effects on parents' mental health and children's mental and physical health. General population of children 0-18 years old and their parents will be explored over a time span of a year (2000 - 2024). To assess rates of dropout from psychotherapy, data derived from Clalit Health Services (CHS) databases will be similarly minded. The data will include information on children and adolescents (6-18) psychotherapies from 2015 - 2024, as well as their caregivers. Children and adolescents will be divided into two groups based on their age (6-11 and 12-18). Inclusion criteria will be children and adolescents who participated in outpatient psychotherapy in CHS databases. Participants will be excluded in case of mental or physical hospitalization during psychotherapy.
Phase II: Prospective exploration of ongoing psychotherapies This phase will explore possible pre-treatment and within-treatment predictors of adolescents' psychotherapy outcome and dropout. The phase will include three groups of participants: patients (adolescents between the ages 11-18), patient's caregivers, and therapists in the child and adolescent clinic in Shalvata Mental Health Center (MHC). Inclusion criteria for patients and caregivers include participation in psychotherapy in the Crisis Intervention Unit in Shalvata MHC. Inclusion criteria for therapists will be as follows (1) a professional license to practice psychotherapy (2) conducting psychotherapy in the child and adolescent clinic in Shalvata MHC. Patients and caregivers will be excluded in case of not being able to or willing to sign informed consent, or if there is an immediate risk, as evaluated by the treating physician.
Procedure Phase I: Retrospective data phase To assess national trends in child and adolescent health since the 7th of October, Clalit anonymous database will be utilized. Data will be retrieved from databases according to the study protocol. The data timespan is from 2015 to 2024. To examine dropout rates among children and adolescents, and explore potential pre-treatment predictors, data will be extracted from the electronic health records of Clalit Health Services.
Validation Process This is the first study to utilize psychotherapy data from the electronic health records of Clalit Health Services (CHS database). Therefore, before conducting data mining for the specific research questions, the data must first undergo a process to ensure validity and reliability. This involves crossing the raw patient identified data exported from the hospital system with anonymized data from the CHS database. The research team will work with the research room of the CHS database and the computing unit at Shalvata Mental Health Center. Only the main researchers and research room team will be exposed to raw patient identified data and only through the reliability phase. Following this reliability stage, all data will be anonymized and unidentified, according to research room regular procedure. Then, the research team will utilize just the unidentified data for the following analysis. Measure exported are elaborated in the measures section (measures phase 1).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Children and their mothers are members of Clalit Health Services.
- •Children and adolescents who received outpatient psychotherapy.
- •Aged 6-18 years at the start of psychotherapy.
排除标准
- •Psychiatric hospitalization during the course of psychotherapy.
- •Mothers who are not members of Clalit Health Services.
- •Inclusion Criteria:
- •Children and their caregivers receiving treatment at the Crisis Intervention Unit at Shalvata Mental Health Center (MHC).
- •Therapists who hold a professional license to practice psychotherapy.
- •Therapists providing psychotherapy in the Child and Adolescent Clinic at Shalvata MHC.
- •Exclusion Criteria:
- •Patients and caregivers who are unable or unwilling to provide informed consent.
- •Patients who are at immediate risk, as determined by the treating physician.
研究组 & 干预措施
Crisis Intervention Clinic
Children and adolescents receiving therapy in the crisis intervention center were recruited along with their therapist and their parents
CHS insured patients
Children who received psychotherapy in Clalit health services and their mothers
结局指标
主要结局
Health Services Utilization
时间窗: 2 years before the psychotherapy start point and until 2 years after psychotherapy start point
Number of ER visits, Number of Admissions, Number of primary and secondary doctor visits
Symptoms Change
时间窗: From enrollment to the end of treatment up to 7 weeks
changing mental and somatic symptoms
Dropout
时间窗: In study 1: up to 4 months, in study 2: from enrollment to the end of treatment at 7 weeks
Children and adolescents who terminated therapy according to the definition of dropout, including early and late psychotherapy dropout
Symptoms reduction
时间窗: From enrollment to the end of treatment up to 7 weeks
changing mental and somatic symptoms
次要结局
未报告次要终点