Kids2Health Intervention Core – Inducing Healthy Trajectories for Children with ELS

Not Applicable

• Conditions: 1) children aged 6-11 years with a verified history of maltreatment or abuse who additionally show a psychiatric disorder according to ICD-10 axis 1; 2) children aged 3-5 years with a verified history of maltreatment or abuse; 3) children aged 6-11 years with war- and migration-related trauma who show (partial) posttraumatic stress disorder (PTSD) according to ICD-10 or DSM-5, and 4) children aged 3-11 years with obesity and a history of maltreatment/abuse or other forms of early life stress.

• Registration Number: DRKS00015875
• Lead Sponsor: Charité Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-01
• Study Completion: 2022-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

SP1:
1) for the children of the existing cohort of the Berlin Longitudinal Child Study and for newly recruited children aged 6-11 years with a history of maltreatment: the presence of a psychiatric disorder according to ICD-10 axis 1, as diagnosed by a structured clinical interview with the caregiver; for the new group of children aged 3-5 years: the presence of maltreatment according to the maltreatment classification system with severity scores =2.
2) timely availability for the participation in weekly therapy sessions over the course of 16 weeks;
3) sufficient German language skills
4) caretaker availability for TF-CBT
5) sufficiently stable psychosocial situation

TP2:
1) presence of PTSD according to ICD-10 (defined by clinical interview) or PTSD or partial PTSD according to DSM-5, defined by the UCLA PTSD Reaction Index. Partial PTSD is defined by the presence of a traumatic event, the presence of 2 out of 4 symptom clusters and the presence of clinically significant distress or impairment in functioning.
2) timely availability for the participation in weekly therapy sessions over the course of 12 weeks;
3) sufficiently stable psychosocial situation

SP4:
1) exposure to moderate ELS, including child maltreatment as defined by the maltreatment classification system with a severity score =2 or including prolonged separation from a parent, severe life-threatening illness in child, siblings, or parents, war-related trauma, natural disasters, and accidents, as assessed using structured interviews;
2) timely availability for the participation in weekly therapy sessions over the course of 16 weeks;
3) sufficient German language skills
4) caretaker availability for TF-CBT
5) sufficiently stable psychosocial situation

Exclusion Criteria

TP1, TP2 und TP4:

1) child currently in psychotherapy;
2) acute severe psychiatric disorder (e.g., psychosis);
3) acute and severe somatic disorder;
4) acute suicidality;
5) severe or life-threatening self-injuries during the last 6 months;
6) presence of a pervasive developmental disorder (e.g. autism);
7) mental retardation (IQ < 70);
8) further assessment needed due to complexity of symptoms;
9) indication for inpatient treatment or other further care/intervention.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary efficacy endpoint: Primary endpoint is child mental health, defined by symptom scores and by the presence of a psychiatric disorder according to ICD-10 and according to the level of clinical symptoms.<br><br>Child mental health as primary endpoint will be assessed by a semistructured clinical interview (K-Sads-PL) and by validated questionnaires in child self report if child age is > 6 years and in parent report (SCARED, CES-DC, UCLA-RI, CBCL).<br><br>Child mental health will be assessed at all time points of measurement, i.e., baseline pre intervention, T1 post intervention, 6-, 12-, and 18 months post intervention. <br><br>In addition, we will test whether changes in embedding trajectories predict primary efficacy outcomes.