Community Research and Development Information Service - CORDIS

FP7

FEMNAT-CD Report Summary

Project ID: 602407
Funded under: FP7-HEALTH
Country: Germany

Periodic Report Summary 2 - FEMNAT-CD (Neurobiology and Treatment of Adolescent Female Conduct Disorder: The Central Role of Emotion Processing)

Project Context and Objectives:
The FemNAT-CD study on “Neurobiology and Treatment of Adolescent Female Conduct Disorder: The Central Role of Emotion Processing” focuses on paediatric conduct disorder (CD) in females during late childhood and adolescence by, first, a cross-sectional and, second, a longitudinal approach. It aims at studying the phenotypic subgroups, their underlying neurobiological and neurocognitive mechanisms leading to pathological aggression in females compared to males, the longitudinal course of CD in females, and to apply a new psychotherapeutic approach in adolescent females within a randomised controlled trial. In addition, innovative pharmaco-challenge studies are performed in animals and humans.

1) Clarify the phenomenology and neurobiology of female CD from pre-puberty to post-puberty. We study:
1.1 the role of complex main and interacting genetic and environmental risk factors on female CD, related psychopathology, brain function and structure, HPA axis and ANS disturbances to identify CD specific endophenotypes and related biomarkers;
1.2 female CD specific epigenetic changes and associated early psychosocial and biological environmental risk factors;
1.3 the clinical, neural and neurocognitive phenotype of female CD from pre- to postpuberty and related neuroendocrine and ANS function as well as moderating, mediating and direct risk factors to identify neurobiologically and phenotypically distinct homogeneous subtypes to guide future, targeted treatment approaches.

2) Translate knowledge of neuropsychological and neurobiological characteristics into targeted intervention
2.1 Based on the central role of EP in female CD, we will study the effect of a DBT-CD-A psychological treatment program focusing on improving emotion regulation, emotion recognition, distress tolerance and interpersonal effectiveness.
2.2 Based on the central role of oxytocin and serotonin in emotion recognition, representation and regulation, their differential effects on neural functions underlying emotion processing and aggressive behaviour will be studied in a female animal model, and two proof-of-concept pharmaco-challenge studies with intranasal oxytocin and the serotonin precursor L-tryptophan (TRP) will be performed in human female CD.
2.3 Results of the pharmaco-challenge and epigenetic studies will be explored for their pharmaceutical potential.

3) Societal and educational objectives
3.1 Provide clinicians, researchers, youth welfare and forensic services with training on assessment instruments, different CD subtypes, and psychotherapeutic methods, and with information on therapeutic interventions to be effectively used in female CD.
3.2 Provide adolescents with CD and their families with evidence based diagnostic and therapeutic approaches, to explain risk and protective factors to these families, and to improve the long-term course of the disorder by targeted treatment.

Project Results:
1. Finalization of the full assessment battery for the cross-sectional and longitudinal study, including phenotypic, genetic, epigenetic, neuropsychological, neurophysiological, endocrine and brain imaging assessments.
2. All ethical permissions obtained for cross-sectional and longitudinal study as well as the randomized-controlled trial.
3. Amendments submitted to and being granted by the relevant ethical committees; content of the amendments see amendments to the EC related to the DOW, No. 2 and No. 3.
4. Standard operation procedures, database and monitoring process as well as data checking procedures implemented and regularly updated for cross-sectional and longitudinal study.
5. Around 75% of the cross-sectional study data collection completed.
6. Around 45% of the individuals for the randomized-controlled study (WP7) randomized.
7. Manual for the dialectic behavioural intervention “START NOW” finalized in German and Dutch (adapted from the US-American Manual).
8. Ongoing training of the staff of involved Youth Welfare Organisations in the correct conduct of the “START NOW” manual and group based intervention.
9. Set-Up of the pharmaco-challenge studies completed (including a testing phase to establish the protocol).
10. All ethical permissions and relevant amendments obtained for the pharmaco-challenge studies.
11. All ethical permissions obtained for the female rat model study.
12. Study Website completed.
13. Study results presented at several conferences.
14. Several presentations and talks in front of diverse audiences (schools, youth welfare organisation, parents, patients, public health related professions, youth detention institutions, etc.).
15. Regular meetings and phone conferences implemented.
16. Regular trainings in data collection procedures at General Assembly Meetings implemented.
17. Publication plan for major consortium publications agreed upon.

Main results:
1. Approx. 75% of the cross-sectional sample fully assessed and all data entered into database.
2. Approx. 6% of the longitudinal study assessed.
3. Statistical analyses done for conference talks and publications on phenotypic data (psychiatric comorbidity and risk factors), neuropsychological data, neuroendocrine data, neurophysiological data, and brain imaging data.
4. START NOW manual available for all centres participating in RCT.
5. Around 45% of the individuals for the randomized-controlled study (WP7) randomized; most phenotypic data entered into the data base.
6. Approx. 35% of the participants included in the pharmaco-challenge studies.
7. Five consortium publications submitted and in revision, several publications accepted.

Potential Impact:
We will fully achieve our main targets to
1) Clarify the phenomenology and neurobiology of female CD from pre-puberty to post-puberty.
This will be achieved by analysing the data from the large cross-sectional and longitudinal study in the specific areas of the work packages: phenotype, genetics and epigenetics, neuropsychology, neurophysiology, neuroendocrinology, and brain imaging. Results for the first time will help clinicians and basic researchers to get a better understanding of the differences between females and males with CD, the different CD subtypes and their course, which is of immediate use especially for psychoeducation of affected individuals, their primary caregivers, teachers and staff in youth welfare organisations. Ultimately, these results will lead to new ideas for prevention and intervention, based on the respective neurobiologically based mechanisms underlying female CD.
2) Translate knowledge of neuropsychological and neurobiological characteristics into targeted intervention.
Both, the psychotherapy RCT and the proof-of-concept pharmaco-challenge studies are based on previous basic research findings on the central role of emotion processing, and biological mediators and moderators of emotion processing. If proven effective, especially the behavioural intervention can be directly implemented in clinical practise.
3) Societal and educational objectives
We already are providing clinicians, researchers, youth welfare and forensic services with information on the study, the implemented methods for diagnosis and intervention. We also provide adolescents with CD and their families with evidence based diagnostic and therapeutic approaches, we explain risk and protective factors to these families, and aim at improving the long-term course of the disorder by targeted treatment.

List of Websites:
http://www.femnat-cd.eu/

Related information

Reported by

JOHANN WOLFGANG GOETHE UNIVERSITAET FRANKFURT AM MAIN
Germany

Subjects

Life Sciences
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