Affective Dysregulation in Childhood – Optimizing Prevention and Treatment (ADOPT): Efficacy of a personalized modular outpatient treatment program to treat affective dysregulation and comorbid disorders in out-of-home care children.
Organizational Data
- DRKS-ID:
- DRKS00014581
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2018-07-04
- Last update in DRKS:
- 2023-08-03
- Registration type:
- Prospective
Acronym/abbreviation of the study
ADOPT Institution
URL of the study
Brief summary in lay language
ADOPT-Institution is part of a joint research project (ADOPT), aiming at optimizing prevention and treatment of affective dysregulation in children (i.e. reacting overly angry or aggressive in response to provocations). In order to ameliorate prevention approaches, new assessment tools will be developed and evaluated, the frequency of affective dysregulation symptoms will be investigated, and risk and protective factors will be analyzed (sub-project ADOPT-epidemiology). Likewise, an online self-help training program for parents will be developed and evaluated (sub-project ADOPT-online), in which e.g. positive interaction methods will be teached. As there is currently no special treatment program for children with affective dysregulation, the development and evaluation of a modularized psychotherapy program will be subject of two other sub-projects (ADOPT-treatment, ADOPT-institution). While the evaluation sample of ADOPT-treatment will be children, who still live in their family homes, ADOPT-institution will investigate the effects the treatment has on children in out-of-home care. According to the higher amount of adverse childhood experiences in this population, those children are exposed to higher risks in developing symptoms of affective dysregulation.
Brief summary in scientific language
ADOPT-Institution is part of a multi-center joint research project (ADOPT), aiming at optimizing prevention and treatment of affective dysregulation in children aged 8;0 to 12;11 years. ADOPT consists of five interrelated sub-projects, which will be conducted at several study centers and which use approximately the same assessment instruments. The main objectives of ADOPT include the development and evaluation of new assessment tools as well as investigations concerning the epidemiology of affective dysregulation (including the prevalence of symptoms and comorbid disorders) and psychosocial risk and protective factors (sub-project ADOPT-epidemiology). Moreover, an easy accessible and cost-effective online-treatment program for parents (sub-project ADOPT-online) as well as a modularized treatment program to use in out-patient psychotherapy (sub-project ADOPT-treatment) will be developed and evaluated in randomized-controlled trials. The evaluation of the therapy program will include two different samples of children with affective dysregulation: On the one hand children, who still live in their family homes (ADOPT-treatment), and on the other hand children in out-of-home care (ADOPT-institution).
Health condition or problem studied
- Free text:
- Affective Dysregulation
- Free text:
- F 34.8 (DSM-V): Disruptive mood dysregulation disorder; NIMH Research Domain Criteria (RDoC) Initiative: Negative emotionality, Frustrative non-reward
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Modular Outpatient Treatment of Affective Dsyregulation and coexisting disorders (PeMOT-AD; 9 moths, 24 sessions in total): The program is leaned on evidence-based cognitive-behavoral therapy (CBT) programs (e.g. Coping Power Program, Cognitive-behavioral Therapy for Anger and Aggression in Children, MATCH-ADTC) and consists of individualized training sessions for children, parents and teachers. In detail, children will be trained in anger control and emotion regulation (module 1), problem solving and social skills (modules 2+3), empathy sensing skills (module 4), organizational skills (module 4) and coping with traumata and negative live events (module 6). In addition, parents and teachers will be instructed to reduce dysfunctional (modules 7+9) and strengthen positive parenting behavior and interactions with the child (modules 8+10).
- Arm 2:
- Treatment-as-Usual (TAU; control group; 9 months): The treatment will follow accepted guidelines and regular treatment schemes, and will take place in the institutes outpatient clinics or with outpatient practitioners (psychiatrists or psychotherapists).
- Arm 3:
- Children without affective dysregulation (observation group)
Endpoints
- Primary outcome:
- AD-symptoms: To assess symptoms of affective dysregulation, a newly developed clinician-rated interview (Outcome Measure for Affective Dysregulation: OMAD) to evaluate caregiver (in this sub-project foster parents or child care workers from youth welfare institutions) information about the child will be used. The assessments will take place immediately before starting the treatment (T1) and immediately after closing it (T2), as well as 8 months after that (T3). The rating of the clinician and the assignment to treatment arms will be conducted independently (blinded rating). The interviews will be audiotaped; 10% of them will be evaluated by a second rater (interrater-reliability).
- Secondary outcome:
- Clinician-rated AD symptoms (children, caregivers, teachers; OMAD), ADHD and conduct disorders (DISYPS-III), other comorbid disorders (CBCL 6-18R; TRF 6-18R), psychological wellbeing oft he child (KIDSCREEN), clinician-rated psychosocial impairment of the child (DISYPS-III). All secondary endpoints will be assessed at T1, T2 and T3.
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
-
- Assessor
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center KJP Köln
- University medical center KJP Köln
- University medical center KJP Ulm
- University medical center KJP Dresden
- University medical center KJP Medizinische Hochschule Brandenburg Neuruppin
- University medical center KJP ZI Mannheim
- University medical center KJP Rostock
Recruitment period and number of participants
- Planned study start date:
- 2018-07-30
- Actual study start date:
- 2018-10-04
- Planned study completion date:
- 2023-07-31
- Actual Study Completion Date:
- 2023-07-31
- Target Sample Size:
- 220
- Final Sample Size:
- 157
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 8 Years
- Maximum Age:
- 12 Years
- Additional Inclusion Criteria:
- age between 8;0 and 12;11 years; living in out-of-home care; clinician-rated AD symptoms > cut-off (OMAD)
Exclusion Criteria
IQ <80; severe mental disorder (profound developmental disorder, schizophrenia, psychosis, bipolar disorder, obsessive compulsive disorder) causing AD symptoms; insufficient language skills of child and/or caregiver; intensive psychotherapy (ongoing or planned)
Addresses
Primary Sponsor
- Address:
- Universitätsklinik UlmSteinhövelstraße 589075 UlmGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsmedizin Rostock, Klinik für Psychiatrie, Neurologie, Psychosomatik und Psychotherapie im Kindes- und JugendalterProf. Dr. Michael KölchGehlsheimer Straße 2018147 RostockGermany
- Telephone:
- 0381-494 4600
- Fax:
- 0381-494 4602
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://kjpp.med.uni-rostock.de/
Contact for Public Queries
- Address:
- Universitätsklinikum Ulm, Klinik für Kinder- und Jugendlichenpsychiatrie/PsychotherapieMarion SteinerSteinhövelstraße 189075 UlmGermany
- Telephone:
- 0731 500-62665
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uniklinik-ulm.de/kinder-und-jugendpsychiatriepsychotherapie.html
Principal Investigator
- Address:
- Universitätsmedizin Rostock, Klinik für Psychiatrie, Neurologie, Psychosomatik und Psychotherapie im Kindes- und JugendalterProf. Dr. Michael KölchGehlsheimer Straße 2018147 RostockGermany
- Telephone:
- 0381-494 4600
- Fax:
- 0381-494 4602
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://kjpp.med.uni-rostock.de/
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Bundesministerium für Bildung und Forschung Dienstsitz BonnHeinemannstr. 253175 BonnGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.bmbf.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Universität UlmHelmholtzstr. 2089081 UlmGermany
- Telephone:
- +49-731-50022050
- Fax:
- +49-731-50022036
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2018-03-13
- Ethics committee number:
- 139/18
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2018-05-17
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- Yes
- IPD Sharing Plan:
- Aggregated data will be available on request, after primary and secondary analyses and publications are finalized. All researchers with a methodological sound proposal will be granted access. In addition to individual data, the study protocol as well as the statistical analysis plan will be available.
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Affective dysregulation in childhood - optimizing prevention and treatment: protocol of three randomized controlled trials in the ADOPT study.
- Otto, C.*, Kaman, A.*, Barkmann, C., Döpfner, M., Görtz-Dorten, A., Ginsberg, C., Zaplana Labarga, S., Treier, A.-K., Roessner, V., Hanisch, C., Koelch, M., Banaschewski, T., & Ravens-Sieberer, U. (2022). The DADYS-Screen – Development and Evaluation of a Screening Tool for Affective Dysregulation in Children. Assessment.
- Kaman, A., Otto, C., Devine, J., Erhart, E., Döpfner, M., Banaschewski, T., Görtz-Dorten, A., Hanisch, C., Kölch, M., Roessner, V., & Ravens-Sieberer, U. (2022) Assessing anger and irritability in children: Psychometric evaluation and normative data for the German version of the PROMIS® Parent Proxy Anger Scale. Quality of Life Research, 31, 831–839.
- Ritschel, A., Döpfner, M., Schürmann, S., Plück, J., Meyer, H., Schottel, M., Ravens-Sieberer, U., Roessner, V., Banaschewski, T., Görtz-Dorten, A., Kölch, M., Treier, A.-K. & Hanisch, C. (2021). Online-Elterntrainings für die Behandlung von Kindern mit externalisierenden Verhaltensproblemen und affektiver Dysregulation. Prävention und Gesundheitsförderung.
- Junghänel, Wand, Dose, Thöne, Treier, Hanisch, Ritschel, Kölch, Lincke, Roessner, Kohls, Ravens-Sieberer, Kaman, Banaschewski, Aggensteiner, Görtz-Dorten, & Döpfner on behalf of the ADOPT Consortium. Validation of a New Emotion Regulation Self-Report Questionnaire for Children. BMC Psychiatry.
- Junghänel, M., Thöne, A., Ginsberg, C., Görtz-Dorten, A., Frenk, F., Mücke, K., Treier, A.-K., Zaplana, S., Banaschewski, T., Millenet, S., Fegert, J., Bernheim, D., Hanisch, C., Kölch, M., Schüller, A., Ravens-Sieberer, U., Kaman, A., Roessner, V., Hinz, J., & Döpfner, M. 2022. Irritability and impulsivity as a core feature of ADHD and ODD in children. Journal of Psychopathology and Behavioral Assessment.
- Treier, A. K., Holas, V., Görtz-Dorten, A., Frenk, F., Goldbeck, C., Mücke, K., Hanisch, C., Ritschel, A., Roessner, V., Rothe, J., Ravens-Sieberer, U., Kaman, A., Banaschewski, T., Brandeis, D., Aggensteiner, P. M., Kölch, M., Daunke, A., Döpfner, M., & ADOPT Consortium. (2022). Impact of the COVID-19 pandemic on children with and without affective dysregulation and their families. Eur Child Adolesc Psychiatry. Advance online publication.
- Franziska Giller, Pascal-M Aggensteiner, Tobias Banaschewski, Manfred Döpfner, Daniel Brandeis, Veit Roessner, Christian Beste (2021). Affective dysregulation in children is associated with difficulties in response control in emotional ambiguous situations. Biological Psychiatry: Cognitive Neuroscience and Neuroimaging.
- Date of first publication of study results:
- 2019-09-02
- DRKS entry published for the first time with results:
- 2023-08-03
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry