NCT07455344 Mechanisms and Outcomes of Children and Adolescent Psychotherapy

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 30,000 participants in total. It began in 2025-01-05 with a primary completion date of 2027-01-30.

Brief Summary

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: 1. Parental psychopathology will mediate the association between traumatic exposure during war and their child's mental and physical health. 2. Dropout rates from psychotherapy in Israel will be found as similar to those reported in a previous meta-analysis (\~45%). 3. Within-treatment variables will have a stronger association with dropout risk and outcome, compared to pre-treatment variables.

Eligibility Criteria

Study 1 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. Exclusion Criteria: * Psychiatric hospitalization during the course of psychotherapy. * Mothers who are not members of Clalit Health Services. Study 2 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.

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