Short-term, Long-term and Cost-effectiveness of Treating Depression and Anxiety Disorders in Children and Adolescents
1 other identifier
interventional
420
0 countries
N/A
Brief Summary
The current study will evaluate and compare the effectiveness of cognitive-behavioral and psychodynamic therapy. Therefore 420 children and adolescents (ages 8-16 years) with depression and/or anxiety disorder will be randomly assigned to a treatment or a control condition. The intervention´s short-term effectiveness and sustainability as well as cost-effectiveness will be examined over a 5 year period for each participant.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2017
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2017
CompletedFirst Posted
Study publicly available on registry
November 6, 2017
CompletedStudy Start
First participant enrolled
December 22, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedDecember 21, 2017
December 1, 2017
5.6 years
September 4, 2017
December 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Change from baseline children´s psychiatric symptomatology at 12 months
Children´s psychiatric symptomatology will be assessed in all groups (intervention groups and control group) by an external independent interview (Kiddie-SADS; Kaufman et al., 1996). The Kiddie-SADS interview will be conducted by a trained rater external to the project.
baseline and 12 months
Change from baseline children´s psychiatric symptomatology at 24 months
Children´s psychiatric symptomatology will be assessed in all groups (intervention groups and control group) by an external independent interview (Kiddie-SADS; Kaufman et al., 1996). The Kiddie-SADS interview will be conducted by a trained rater external to the project.
baseline and 24 months
Change from baseline children´s psychiatric symptomatology at 36 months
Children´s psychiatric symptomatology will be assessed in all groups (intervention groups and control group) by an external independent interview (Kiddie-SADS; Kaufman et al., 1996). The Kiddie-SADS interview will be conducted by a trained rater external to the project.
baseline and 36 months
Change from baseline children´s psychiatric symptomatology at 48 months
Children´s psychiatric symptomatology will be assessed in all groups (intervention groups and control group) by an external independent interview (Kiddie-SADS; Kaufman et al., 1996). The Kiddie-SADS interview will be conducted by a trained rater external to the project.
baseline and 48 months
Change from baseline children´s psychiatric symptomatology at 60 months
Children´s psychiatric symptomatology will be assessed in all groups (intervention groups and control group) by an external independent interview (Kiddie-SADS; Kaufman et al., 1996). The Kiddie-SADS interview will be conducted by a trained rater external to the project.
baseline and 60 months
Secondary Outcomes (50)
Change from baseline children´s depressive symptomatology at 12 months
baseline and 12 months
Change from baseline children´s depressive symptomatology at 24 months
baseline and 24 months
Change from baseline children´s depressive symptomatology at 36 months
baseline and 36 months
Change from baseline children´s depressive symptomatology at 48 months
baseline and 48 months
Change from baseline children´s depressive symptomatology at 60 months
baseline and 60 months
- +45 more secondary outcomes
Study Arms (3)
psychodynamic psychotherapy
EXPERIMENTALcognitive behavioral psychotherapy
EXPERIMENTALpsychodynamic family intervention
ACTIVE COMPARATORInterventions
the intervention follows the published in german manual: Psychoanalytische Behandlung von Kindern und Jugendlichen mit Angststörungen und Depressionen: Behandlungsmanual (Baumeister-Duru, Hofmann, Timmermann \& Wulf, 2013)
the interventions follow the published in german manuals: Depression (Ihle, Groen, Walter, Esser, \& Petermann, 2012) and Soziale Ängste und Leistungsängste (Büch, Döpfner, \& Petermann, 2015)
the intervention follows an adapted version of the manual: Chimp´s - Children of mentally ill parents (Wiegand-Gefe, Halverscheid, \& Plass, 2011)
Eligibility Criteria
You may qualify if:
- diagnosis of a depressive disorder (ICD-10; F30-F39) or an anxiety disorder (ICD-10; F40-F42)
- informed consent
- ages 8 to 16 years
You may not qualify if:
- psychotic disorders, eating disorders, substance use related disorders (except caffeine and nicotine), autism spectrum disorders, mutism, personality disorders
- neurologic disorders
- severe mental retardation (filling out questionnaires and interview are not feasible)
- low command of the german language
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universitätsklinikum Hamburg-Eppendorflead
- University of Bremencollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Silke Wiegand-Grefe, Prof. Dr.
UKE Universitätsklinikum Hamburg-Eppendorf
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
September 4, 2017
First Posted
November 6, 2017
Study Start
December 22, 2017
Primary Completion
August 1, 2023
Study Completion
August 1, 2023
Last Updated
December 21, 2017
Record last verified: 2017-12