NCT07455344

Mechanisms and Outcomes of Children and Adolescent Psychotherapy

Recruiting now Last updated 6 March 2026

What this trial tests

trial in Mental Health in 30,000 participants. Currently enrolling.

Timeline

5 January 2025

Primary endpoint
30 January 2027

30 January 2028

Quick facts

Lead sponsor	Shalvata Mental Health Center
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	30,000
Start date	5 January 2025
Primary completion	30 January 2027
Estimated completion	30 January 2028
Sites	1 location across Israel

Conditions studied

• Mental Health — all drugs for Mental Health →

Sponsor

Shalvata Mental Health Center — full company profile →

Who can join

6 and older, any sex, with Mental Health. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 (Slone et al., 2017). 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 (McElroy et al., 2024). 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% (De Haan et al., 2013). 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 (De Soet et al., 2023; Skar et al., 2022). The second dimension is related to within-therapy factors, such as patients' expectations and the quality of mutual work with the therapist (O'Keeffe et al., 2018). 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%) (De Haan et al., 2013).
3. Within-treatment variables will have a stronger association with dropout risk and outcome, compared to pre-treatment variables.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.