Bringing empirically supported treatments to children and adolescents after child abuse and neglect

Not Applicable

Recruiting

• Conditions: Posttraumatic Stress Disorder or high posttraumatic stress symptoms (CATS-2 score > 21); F43.1; Post-traumatic stress disorder

• Registration Number: DRKS00020516
• Lead Sponsor: Johann-Wolfgang-Goethe Universität Frankfurt

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

In this study, there are two levels of participants with their respective inclusion criteria.

I) Psychotherapists (planned n = 116) inclusion: (1.) work as a (PIT) in one of the collaborating state approved postgradual psychotherapy training institutes (SAPPTIs) or as a LPT in one of the selected regions who (2) are willing to participate in the study and give informed consent.

II) Patient (planned n = 580) inclusion: (1.) age 5-20 years; (2.) experience of abuse or neglect (3.) clinical diagnosis of maltreatment-related PTSD according to the diagnostic criteria of ICD-10, or any mental disorder and at least a score of 21 on the Child and Adolescent Trauma Screen (CATS-2); (4.) travel time from their place of living to the treatment site less than one hour; (5.) patients and caregiver are willing to participate in the study and give informed consent; (6.) at least one caregiver is available and committed to attending the regular treatment sessions.

Exclusion Criteria

In this study, there are two levels of participants with their respective exclusion criteria.
I) Psychotherapist exclusion: the time available before the end of their training program (PIT) or their retirement (LPT) is insufficient for the training and the treatment of the patients. Time is deemed insufficient in case a PIT has less than 12 months of training at the SAPPTI’s outpatient unit before the expected graduation from the training course and in case of an LPT if retirement or change of career is planned in less than 48 months from randomization.
II) Patient exclusion: (1.) severe mental retardation (intelligence quotient (IQ) of < 50; (2.) current psychosis, severe substance disorder or acute suicidality; (3.) any other current psychotherapy; (4.) stable psychotropic medication will be allowed but carefully monitored.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is the number of patients who receive a sufficiently adherent TF-CBT treatment (SATT). What counts as a SATT is defined as:<br>1.) the patient has received at least 8 sessions<br>2.) Modules 1-5 (PRAC) must be completed prior to beginning the trauma narrative.<br>3.) at least one therapy session on the trauma narrative has been conducted<br>4.) trauma narrative was started no later than patient session 22.<br>Whether the patient has received a SATT will be rated by blinded assessors on the basis of the TF-CBT Goal Checklist with which each therapist records after each session, which TF-CBT modules he/she worked on. Analysis will proceed on an ITT basis.<br>