Efficacy of Internet Based Parent Management Training in the Treatment of Afective Dysregulation and Coexisting Conditions in Children
Organizational Data
- DRKS-ID:
- DRKS00014963
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2018-06-27
- Last update in DRKS:
- 2022-01-03
- Registration type:
- Prospective
Acronym/abbreviation of the study
ADOPT online
URL of the study
Brief summary in lay language
When children suffer from problems in dealing with negative emotions like anger or sadness we call this Affective Dysregulation. Those children show bursts of anger, persistent irritability, bad temper and sudden mood changes. The aim of this study is to develop an online parent training in which parents learn strategies to solve daily problems with their child and to support their child in dealing with negative emotions. Additionally, we will investigate whether the training helps.
Brief summary in scientific language
This subproject is embedded into a study consortium that develops and evaluates a stepped intervention for children with Affective Dysregulation at seven sites in Germany. In this subproject called ADOPT online, the efficacy of an Online Parent Self-Help of Affective Dysregulation and coexisting disorders (OnPaSH-AD) is to be investigated compared to treatment as usual. The term Affective Dysregulation describes a transdiagnostic dimension and characterizes an excessive reactivity to negative emotional stimuli with an affective (anger) and a behavioral component (aggression). An evaluated online training for parents of children with ADHD has been supplemented with evidence-based interventions for the improvement of emotion regulation. In a randomized control trial the efficacy will be assessed over a reduction of symptoms of affective dysregulation, comorbid conditions, functional impairment and psychosocial wellbeing. Amendment: Reduction of sample size after renewed power calculation considering current meta-analysises and a modification of the stepped care design (vote in favour on 22.02.2019 and on 05.02.2019)
Health condition or problem studied
- ICD10:
- F34.8 - Other persistent mood [affective] disorders
- Free text:
- mood dysregulation as transdiagnostic dimension
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Intervention group: online parent training at least one hour weekly for 12 weeks
- Arm 2:
- Treatment as usual: Parents of this group are advised to search for a psychosocial support if wanted (e.g. education counselling, outpatient psychotherapy) or to wait. After a 12 weeks waiting phase they gain access to the online parent training.
Endpoints
- Primary outcome:
- Blinded clinician-rated AD (=Affective Dysregulation) symptom score of the child, assessed with a newly developed outcome measure for AD (DADYS interview) based on patient and parent interview at T1-T4
- Secondary outcome:
- (1) psychosocial impairment of the child due to AD symptoms based on patient and parent interview (DADYS interview/DADYS questionnaire) (2) patient- and parent-rated AD symptoms of the child (DADYS questionnaire) (3) patient- and parent-rated symptoms of ADHD and ODD/CD (SBB-ADHS/-SSV, FBB-ADHS/-SSV) (4) other comorbid conditions (e.g., anxiety, depression) assessed by parent-ratings (CBCL 6-18R) (5) psychological well-being in patient- and parent-rating (KIDSCREEN-27) (6) parental satisfaction with the treatment (self-developed questionnaire) (1)-(5) will be collected at T1-T4; (6) will be collected at T2
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Other
- Phase:
- II
- 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 Universitätsklinik Hamburg-Eppendorf, Klinik für Kinder- und Jugendpsychiatrie, -psychotherapie und -psychosomatik, Forschungsabteilung Child Public Health Hamburg
- University medical center Uniklinik Köln, Klinik und Poliklinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters, Ausbildungsinstitut für Kinder- und Jugendlichenpsychotherapie (AKiP) Köln
- Other Universität zu Köln, Humanwissenschaftliche Fakultät, Ki-Ju-Ambulanz Köln
- University medical center Zentralinstitut für seelische Gesundheit, Klinik für Psychiatrie und Psychotherapie des Kindes- und Jugendalters Mannheim
- University medical center Universitätsklinikum Dresden, Klinik und Poliklinik für Kinder- und Jugendpsychiatrie und -psychotherapie Dresden
- University medical center Klinik für Kinder- und Jugendpsychiatrie/Psychotherapie, Psychiatrische Institutsambulanz für Kinder und Jugendliche (KJPIA), Ausbildungszentrum für Verhaltenstherapie (AZVT) Ulm
Recruitment period and number of participants
- Planned study start date:
- 2018-07-09
- Actual study start date:
- 2018-07-09
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2019-12-05
- Target Sample Size:
- 200
- Final Sample Size:
- 281
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 107 Months
- Maximum Age:
- 155 Months
- Additional Inclusion Criteria:
- - Age 8;0 to 12;11 yrs. - Resident with at least one natural or adoptive parent - Clinician-rated Outcome Measure for AD (DADYS interview, DADYS questionnaire) > cut-off. The cut-off will be determined by a clinical overall rating of AD at the end of the structured clinical parent interview. - Willingness and ability of parents to participate in the online intervention (existence of an informed consent of the guardians and an assent of the child) - Sufficient knowledge of German language
Exclusion Criteria
- Intelligence <80 (visit to a special school for mental development or to a regular school with funding priority mental development) - Resident without natural or adoptive parents (e.g. foster parents, grandparents) - mental disorder other than Coexisting Conditions (CoCo) is primary disorder and main cause of AD (e.g. autism spectrum disorder) - current or planned intensive behavioral therapy on a weekly/biweekly basis
Addresses
Primary Sponsor
- Address:
- Universität zu Köln Humanwissenschaftliche Fakultät Psychologie und Psychotherapie in Heilpädagogik und RehabilitationProf. Dr. Charlotte HanischKlosterstraße 79b50931 KölnGermany
- Telephone:
- 02214705520
- Fax:
- 02214705576
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.hf.uni-koeln.de/621
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universität zu Köln Humanwissenschaftliche Fakultät Psychologie und Psychotherapie in Heilpädagogik und RehabilitationAnne RitschelKlosterstraße 79b50931 KölnGermany
- Telephone:
- 022147076181
- Fax:
- 02214705576
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.hf.uni-koeln.de/621
Contact for Public Queries
- Address:
- Universität zu Köln Humanwissenschaftliche Fakultät Psychologie und Psychotherapie in Heilpädagogik und RehabilitationAnne RitschelKlosterstraße 79b50931 KölnGermany
- Telephone:
- 022147076181
- Fax:
- 02214705576
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.adopt-studie.de/
Principal Investigator
- Address:
- Universität zu Köln Humanwissenschaftliche Fakultät Psychologie und Psychotherapie in Heilpädagogik und RehabilitationAnne RitschelKlosterstraße 79b50931 KölnGermany
- Telephone:
- 022147076181
- Fax:
- 02214705576
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.hf.uni-koeln.de/621
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:
- BMBF53170 BonnGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Medizinischen Fakultät der Universität zu KölnGleueler Str. 26950935 KölnGermany
- Telephone:
- +49-221-478 82900
- Fax:
- +40-221-478 82905
- 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:
- 2018-01-30
- Ethics committee number:
- 18-033
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2018-06-19
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:
- Study data concerning the primary and secondary outcome wil be provided to other researchers upon request after the completion of statistical analyses.
Study protocol and other study documents
- Study protocols:
- Studienprotokoll ADOPT Online
- 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:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry