Trial document




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  DRKS00020516

Trial Description

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Title

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

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Trial Acronym

BESTFORCAN

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URL of the Trial

http://www.bestforcan.de

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Brief Summary in Lay Language

Some children and adolescents who have experienced abuse or neglect develop a mental disorder as a result. Scientific studies have shown that a specific psychotherapy program called "trauma-focused cognitive behavioural therapy" (TF-CBT), is very effective in reducing traumatic burden and could help many of those children and adolescents. The therapy is short (on average 12-15 two-hour therapy sessions) and is not difficult for psychotherapists to learn. Nevertheless, in German standard care, most children and adolescents who have developed a mental disorder as a result of neglect or abuse do not receive such interventions. The aim of our study is to train psychotherapists in TF-CBT and to investigate how this form of therapy can be made available for more patients. In particular, we want to test whether the number of treated patients can be improved if therapists have the opportunity to participate in regular case conferences (via telephone) with expert supervisors following training in TF-CBT. For this purpose, we compare half of the group of trained therapists who take part in such supervisions as the usually do with the other half who additionally participate in fortnightly telephone case discussions.
Children or adolescents are referred to us by cooperating child and youth welfare institutions or paediatricians, or they can contact us directly themselves. If they are interested, we will provide information about the study and a list of participating therapists nearby. They are then free to contact a therapist of their choice. We will examine whether the therapists implement the scientifically proven therapy steps and whether trauma symptoms of children and adolescents improve after such a therapy.

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Brief Summary in Scientific Language

The aim of the study is the dissemination and further implementation of TF-CBT for children and adolescents with posttraumatic stress symptoms (PTSS) after child abuse and neglect (CAN) by training licensed psychotherapists (LPTs) and psychotherapists in postgradual training (PITs). This may counteract the scarcity of empirically supported treatments (ESTs) offered to this population in German routine care.
With the help of a cluster-randomized controlled study (Hybrid Type III design), the study will evaluate the implementation of this EST with a particular focus on the training of therapists, including the provision of telephone-based case consultations/supervision. The unit of randomization will be the therapists. The main objective is to compare the effectiveness of specialized trauma-focused case consultations/supervision (TFS) to supervision as usual (SAU) with respect to the successful implementation of TF-CBT for children and youths with PTSS by psychotherapists with different levels of professional experience (LPT/PIT). The primary outcome is a dichotomous variable: Did the patient receive a therapy with sufficient adherence to the TF-CBT manual (SATT) (yes/no)? The primary outcome will be analysed with multilevel logistic regression. Secondary outcomes will comprise the following patient-related and therapist-related measures. Patient-related outcomes are (1) the reduction of PTSS (measured with Child and Adolescent Trauma Screen; CATS-2, caregiver and self-rating) from baseline (pre) to post and also to Follow-Up FU; (2) the reduction of depressive symptoms (measured with Mood and Feelings Questionnaire; MFQ, caregiver and self-rating) from pre to post and also to FU. The analyses will be based on intention to treat (ITT) numbers. For the therapists, (1) the self-ratings of insecurity in implementing TF-CBT and (2) their attitude towards ESTs (measured with Evidence-based Practice Attitude Scale; EBPAS-36) will be analysed. Further therapist-related (implementation readiness, professional quality of life) and patient-related (treatment satisfaction) variables will be investigated as exploratory measures.
The trial is designed as an implementation study and will permit naturalistic referrals to the participating therapists by patients, caregivers, child and youth welfare agencies and paediatricians. The strictly defined primary endpoint will allow assessing the role of model-based supervision in the implementation process. The secondary outcomes will allow testing whether improved implementation at the therapist level will result in improved outcomes for patients.

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

inasfar as permitted by data protection on personal application to the PIs; all PIs have to agree.

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Organizational Data

  •   DRKS00020516
  •   2020/02/14
  •   [---]*
  •   yes
  •   Approved
  •   266_19B, Ethik-Kommission der Friedrich-Alexander-Universität Erlangen-Nürnberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F43.1 -  Post-traumatic stress disorder
  •   Posttraumatic Stress Disorder or high posttraumatic stress symptoms (CATS-2 score > 21)
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Interventions/Observational Groups

  •   Licensed psychotherapists and psychotherapists in post-gradual training who have been trained in TF-CBT and receive supervision as usual (SAU) AND fortnightly trauma-focussed case consultations by telephone (TFS).
  •   Licensed psychotherapists and psychotherapists in post-gradual training who have been trained in TF-CBT and who receive supervision as usual (SAU).
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, assessor
  •   Other
  •   Other
  •   Factorial
  •   N/A
  •   N/A
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Primary Outcome

The primary outcome is the number of patients who receive a sufficiently adherent TF-CBT treatment (SATT). What counts as a SATT is defined by reference to the manual as:
1.) the patient receives at least eight (patient and caregiver) sessions (or 16 single sessions) implementing TF-CBT modules (1-5) and
2.) the patient starts with the trauma narrative in sessions 7-11 (double sessions) or 14-22 (single sessions) and
3.) the patient completes the therapy within 18 double (36 single) sessions.
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.

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Secondary Outcome

Secondary outcomes for patients are: (1) the reduction of PTSS (as measured with CATS-2, caregiver and self-rating) from baseline (pre) to post and also to FU; (2) the reduction of depressive symptoms (measured with MFQ, caregiver and self-rating) from pre to post and also to FU. The analyses will be based on ITT numbers.

Secondary outcomes for therapists are: (1) the session-wise self-ratings of insecurity in implementing TF-CBT; (2) their attitude towards ESTs (measured with EBPAS-36) analysed across therapists' baseline (pre web-training), post web-training, post live workshop, post implementing TF-CBT therapy. The analyses regarding therapists will proceed on an intent-to-supervise basis. “Intent-to-supervise” is an ITT-analysis regarding the therapists, who receive a training (SAU or SAU+TFS), i.e. every therapist, once randomized, will be entered into the analysis.

As exploratory outcomes that allow additional in-depth analyses, several therapist and patient related measures will be analysed: Therapist outcomes: training-related outcomes (increase in knowledge and skill across the training components (as tested by the TF-CBT Knowledge and Skills Test), fear of implementing TF-CBT, readiness to implement TF-CBT and the likelihood of implementing TF-CBT) and professional quality of life; patient outcomes (therapy satisfaction): youth welfare and paediatrician outcomes: attitudes towards implementation and evidence-based practice.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
  • other 
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Recruitment

  •   Planned
  •   2020/03/01
  •   116
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional 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.


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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.

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Addresses

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    • Johann-Wolfgang-Goethe Universität Frankfurt
    • Theodor-W.-Adorno-Platz 1
    • 60323  Frankfurt am Main
    • Germany
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    •   [---]*
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    • Johann-Wolfgang-Goethe University Frankfurt, Institut für Klinische Psychologie und Psychotherapie
    • Ms.  Apl. Prof. Dr.  Regina  Steil 
    • Varrentrappstr. 40-42
    • 60486  Frankfurt a.M.
    • Germany
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    • Johann-Wolfgang-Goethe University Institut für Klinische Psychologie und Psychotherapie
    • Ms.  Franziska  Meichsner 
    • Varrentrappstr. 40-42
    • 60486  Frankfurt am Main
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.