An interventional study of psychodynamic psychotherapy and cognitive behavioral psychotherapy in Depression, Anxiety, sponsored by Universitätsklinikum Hamburg-Eppendorf. Status unknown. Open to participants aged 8 Years to 16 Years. Per ClinicalTrials.gov, last updated 2017-12-21.
Sponsored by Universitätsklinikum Hamburg-Eppendorf · Not applicable, Interventional, and Treatment
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Among 24 studies in Depression by Universitätsklinikum Hamburg-Eppendorf — 2 open to participants now, 3 under way, none of them phase 3. Depression · Universitätsklinikum Hamburg-Eppendorf.
Among the 24 studies in Depression by Universitätsklinikum Hamburg-Eppendorf, this one is the 5th largest by planned enrollment of the 23 interventional ones that give a count, is one of 4 that started in 2017, is one of 23 with no phase, and was the 10th registered.
8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.
Browse Depression studies →2 of the 24 studies in Depression by Universitätsklinikum Hamburg-Eppendorf are open now, in 1 country. Recruiting first, the newest first:
Universitätsklinikum Hamburg-Eppendorf · Sites in Germany
Ages 60+ · Healthy volunteers
Universitätsklinikum Hamburg-Eppendorf · Sites in Germany
Ages 12–17
By country, each count listing its studies:
Of the 1,089 Depression studies recruiting now, 470 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 311 take healthy volunteers.
This study: 8 Years to 16 Years · all sexes · no healthy volunteers.
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24 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 4 started in 2017.
This study's planned enrollment of 420 is above the median of 81 across 7,066 interventional studies indexed under Depression.
Median enrollment 127 across the 23 interventional studies, 300 across the 1 observational. Of the 20 that completed or were terminated, 0 (0%) have results posted.
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Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 416 studies on the registry; 86 are open to participants now.
1 of the studies in Depression by Universitätsklinikum Hamburg-Eppendorf that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06831994Universitätsklinikum Hamburg-EppendorfDigital Implementation of the German S3 Clinical Practice Guideline for Multimorbidity | 2027-02-28 |
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Among the 24 studies in Depression by Universitätsklinikum Hamburg-Eppendorf, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
This study aims to optimize patient-centered care and to ensure scientific and legal approval of cognitive-behavioral and psychodynamic therapy for children and adolescents in the German health-care system. This prospective, randomized and controlled trial will therefore compare psychodynamic and cognitive behavioral therapy with a low-frequency family intervention (control intervention) for children and adolescents with depression and anxiety disorder. Number of diagnoses or fulfilled diagnostic criteria - diagnosed by a trained psychologist who is blind for treatment condition - will be the primary outcome. Secondary outcomes are patients´ and parents´ strain caused by symptoms, patients´ quality of life, global and family functioning and treatments´ cost effectiveness are secondary outcomes.
Patients will be recruited at the end of an inpatient hospital stay in northern Germany (Hamburg and Bremen) in two clinics for child and adolescent psychiatry and in surgery. After gathering informed consent from parents and patients, the latter will be randomly assigned to one type of outpatient treatment (psychodynamic, cognitive behavioral therapy or family intervention). Psychodynamic and cognitive-behavioral therapy as well as the control intervention will be provided manual-based. Treatment sessions will be audio recorded to control adherence.
Data will be collected annually over a period of five years starting at the beginning of treatment. This allows examination of varying treatment intervals as well as the sustainability and health economics of therapy effects.
To analyze data, comparisons of means will be performed. Groupwise analyses of interaction will be performed for inferential testing of differences in subgroups. Differences in therapy effects will be inferentially analyzed by multifactor analysis of covariance, analysis of variance or logistic regression. Interaction effects and predicting variables are of special interest.
In a Subsample of 32 depressive adolescents (ages 13-16) patients expectations before and experiences whilst therapy will be analyzed by a mixed-methods-approach.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: psychodynamic psychotherapy
Behavioral: cognitive behavioral psychotherapy
Behavioral: psychodynamic family intervention
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)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline and 60 months
Change from baseline children´s depressive symptomatology at 12 months
Children´s depressive symptomatology will be assessed by children´s (aged 10 years and older) and parents´ rating of the German version of the "Children´s depression inventory" (Depressionsinventar für Kinder und Jugendliche (DIKJ); Stiensmeier-Pelster, Schürmann, \& Duda, 2000). The German version of the "Children´s depression inventory" consists of 26 Items. Each item has 3 response options, which range from 0 = "symptom not present" to 2 = "symptom is very much present". The items are summed up to a total score (0-52), with higher values representing a higher number and more severe depressive symptoms.
Time frame: baseline and 12 months
Change from baseline children´s depressive symptomatology at 24 months
Children´s depressive symptomatology will be assessed by children´s (aged 10 years and older) and parents´ rating of the German version of the "Children´s depression inventory" (Depressionsinventar für Kinder und Jugendliche (DIKJ); Stiensmeier-Pelster, Schürmann, \& Duda, 2000). The German version of the "Children´s depression inventory" consists of 26 Items. Each item has 3 response options, which range from 0 = "symptom not present" to 2 = "symptom is very much present". The items are summed up to a total score (0-52), with higher values representing a higher number and more severe depressive symptoms.
Time frame: baseline and 24 months
Change from baseline children´s depressive symptomatology at 36 months
Children´s depressive symptomatology will be assessed by children´s (aged 10 years and older) and parents´ rating of the German version of the "Children´s depression inventory" (Depressionsinventar für Kinder und Jugendliche (DIKJ); Stiensmeier-Pelster, Schürmann, \& Duda, 2000). The German version of the "Children´s depression inventory" consists of 26 Items. Each item has 3 response options, which range from 0 = "symptom not present" to 2 = "symptom is very much present". The items are summed up to a total score (0-52), with higher values representing a higher number and more severe depressive symptoms.
Time frame: baseline and 36 months
Change from baseline children´s depressive symptomatology at 48 months
Children´s depressive symptomatology will be assessed by children´s (aged 10 years and older) and parents´ rating of the German version of the "Children´s depression inventory" (Depressionsinventar für Kinder und Jugendliche (DIKJ); Stiensmeier-Pelster, Schürmann, \& Duda, 2000). The German version of the "Children´s depression inventory" consists of 26 Items. Each item has 3 response options, which range from 0 = "symptom not present" to 2 = "symptom is very much present". The items are summed up to a total score (0-52), with higher values representing a higher number and more severe depressive symptoms.
Time frame: baseline and 48 months
Change from baseline children´s depressive symptomatology at 60 months
Children´s depressive symptomatology will be assessed by children´s (aged 10 years and older) and parents´ rating of the German version of the "Children´s depression inventory" (Depressionsinventar für Kinder und Jugendliche (DIKJ); Stiensmeier-Pelster, Schürmann, \& Duda, 2000). The German version of the "Children´s depression inventory" consists of 26 Items. Each item has 3 response options, which range from 0 = "symptom not present" to 2 = "symptom is very much present". The items are summed up to a total score (0-52), with higher values representing a higher number and more severe depressive symptoms.
Time frame: baseline and 60 months
Change from baseline children´s anxiety at 12 months
Children´s anxiety symptomatology will be assessed by children´s (aged 10 years and older) and parents´ rating of the German version of the "Screen for child anxiety related emotional disorders" (Scared; Birmaher, Khetarpal, Cully, Brent, \& McCanzie, 1995). The German version of the Scared consists of 41 items. Each item has 3 response options, which range from 0 = "not true or hardly ever true" to 2 = "true or often true". The subscales to be calculated are "panic/somatic" with a summed score ranging from 0 to 26, "generalized anxiety" with a summed score ranging from 0 to 18, "separation anxiety" with a summed score ranging from 0 to 16, "social phobia" with a summed score ranging from 0 to 14 and "school phobia" with a summed score ranging from 0 to 8. A total score can be obtained ranging from 0 to 82 by summing all scores. For all subscales and the total score higher values indicate a higher degree of anxiety.
Time frame: baseline and 12 months
Change from baseline children´s anxiety at 24 months
Children´s anxiety symptomatology will be assessed by children´s (aged 10 years and older) and parents´ rating of the German version of the "Screen for child anxiety related emotional disorders" (Scared; Birmaher, Khetarpal, Cully, Brent, \& McCanzie, 1995). The German version of the Scared consists of 41 items. Each item has 3 response options, which range from 0 = "not true or hardly ever true" to 2 = "true or often true". The subscales to be calculated are "panic/somatic" with a summed score ranging from 0 to 26, "generalized anxiety" with a summed score ranging from 0 to 18, "separation anxiety" with a summed score ranging from 0 to 16, "social phobia" with a summed score ranging from 0 to 14 and "school phobia" with a summed score ranging from 0 to 8. A total score can be obtained ranging from 0 to 82 by summing all scores. For all subscales and the total score higher values indicate a higher degree of anxiety.
Time frame: baseline and 24 months
Change from baseline children´s anxiety at 36 months
Children´s anxiety symptomatology will be assessed by children´s (aged 10 years and older) and parents´ rating of the German version of the "Screen for child anxiety related emotional disorders" (Scared; Birmaher, Khetarpal, Cully, Brent, \& McCanzie, 1995). The German version of the Scared consists of 41 items. Each item has 3 response options, which range from 0 = "not true or hardly ever true" to 2 = "true or often true". The subscales to be calculated are "panic/somatic" with a summed score ranging from 0 to 26, "generalized anxiety" with a summed score ranging from 0 to 18, "separation anxiety" with a summed score ranging from 0 to 16, "social phobia" with a summed score ranging from 0 to 14 and "school phobia" with a summed score ranging from 0 to 8. A total score can be obtained ranging from 0 to 82 by summing all scores. For all subscales and the total score higher values indicate a higher degree of anxiety.
Time frame: baseline and 36 months
Change from baseline children´s anxiety at 48 months
Children´s anxiety symptomatology will be assessed by children´s (aged 10 years and older) and parents´ rating of the German version of the "Screen for child anxiety related emotional disorders" (Scared; Birmaher, Khetarpal, Cully, Brent, \& McCanzie, 1995). The German version of the Scared consists of 41 items. Each item has 3 response options, which range from 0 = "not true or hardly ever true" to 2 = "true or often true". The subscales to be calculated are "panic/somatic" with a summed score ranging from 0 to 26, "generalized anxiety" with a summed score ranging from 0 to 18, "separation anxiety" with a summed score ranging from 0 to 16, "social phobia" with a summed score ranging from 0 to 14 and "school phobia" with a summed score ranging from 0 to 8. A total score can be obtained ranging from 0 to 82 by summing all scores. For all subscales and the total score higher values indicate a higher degree of anxiety.
Time frame: baseline and 48 months
Change from baseline children´s anxiety at 60 months
Children´s anxiety symptomatology will be assessed by children´s (aged 10 years and older) and parents´ rating of the German version of the "Screen for child anxiety related emotional disorders" (Scared; Birmaher, Khetarpal, Cully, Brent, \& McCanzie, 1995). The German version of the Scared consists of 41 items. Each item has 3 response options, which range from 0 = "not true or hardly ever true" to 2 = "true or often true". The subscales to be calculated are "panic/somatic" with a summed score ranging from 0 to 26, "generalized anxiety" with a summed score ranging from 0 to 18, "separation anxiety" with a summed score ranging from 0 to 16, "social phobia" with a summed score ranging from 0 to 14 and "school phobia" with a summed score ranging from 0 to 8. A total score can be obtained ranging from 0 to 82 by summing all scores. For all subscales and the total score higher values indicate a higher degree of anxiety.
Time frame: baseline and 60 months
Change from baseline parent reported children´s psychiatric symptoms at 12 months
Children´s psychiatric disorders will be assessed by parents´ rating of the German version of the "Child behavior checklist" (CBCL; Achenbach, 1991). The German version of the CBCL consists of 118 items. Each item has 3 response options, which range from 0 = "not true or seldom true" to 2 = "true or often true". The 8 syndrome scales to be calculated by summing are "social withdrawal" with scores ranging from 0 - 18, "physical discomfort" with scores ranging from 0 - 18, "anxiety/depression" with scores ranging from 0 - 28, "social difficulties" with scores ranging from 0 - 16, "schizoid/compulsive" scores ranging from 0 - 14, "attention deficits" with scores ranging from 0 - 22, "dissocial behavior" with scores ranging from 0 - 26, "aggressive behavior" with scores ranging from 0 - 40 and "other difficulties" with scores ranging from 0 - 66. A total score can be calculated by summing with scores ranging from 0 - 236. For all scales higher values indicate a higher problem level.
Time frame: baseline and 12 months
Change from baseline parent reported children´s psychiatric symptoms at 24 months
Children´s psychiatric disorders will be assessed by parents´ rating of the German version of the "Child behavior checklist" (CBCL; Achenbach, 1991). The German version of the CBCL consists of 118 items. Each item has 3 response options, which range from 0 = "not true or seldom true" to 2 = "true or often true". The 8 syndrome scales to be calculated by summing are "social withdrawal" with scores ranging from 0 - 18, "physical discomfort" with scores ranging from 0 - 18, "anxiety/depression" with scores ranging from 0 - 28, "social difficulties" with scores ranging from 0 - 16, "schizoid/compulsive" scores ranging from 0 - 14, "attention deficits" with scores ranging from 0 - 22, "dissocial behavior" with scores ranging from 0 - 26, "aggressive behavior" with scores ranging from 0 - 40 and "other difficulties" with scores ranging from 0 - 66. A total score can be calculated by summing with scores ranging from 0 - 236. For all scales higher values indicate a higher problem level.
Time frame: baseline and 24 months
Change from baseline parent reported children´s psychiatric symptoms at 36 months
Children´s psychiatric disorders will be assessed by parents´ rating of the German version of the "Child behavior checklist" (CBCL; Achenbach, 1991). The German version of the CBCL consists of 118 items. Each item has 3 response options, which range from 0 = "not true or seldom true" to 2 = "true or often true". The 8 syndrome scales to be calculated by summing are "social withdrawal" with scores ranging from 0 - 18, "physical discomfort" with scores ranging from 0 - 18, "anxiety/depression" with scores ranging from 0 - 28, "social difficulties" with scores ranging from 0 - 16, "schizoid/compulsive" scores ranging from 0 - 14, "attention deficits" with scores ranging from 0 - 22, "dissocial behavior" with scores ranging from 0 - 26, "aggressive behavior" with scores ranging from 0 - 40 and "other difficulties" with scores ranging from 0 - 66. A total score can be calculated by summing with scores ranging from 0 - 236. For all scales higher values indicate a higher problem level.
Time frame: baseline and 36 months
Change from baseline parent reported children´s psychiatric symptoms at 48 months
Children´s psychiatric disorders will be assessed by parents´ rating of the German version of the "Child behavior checklist" (CBCL; Achenbach, 1991). The German version of the CBCL consists of 118 items. Each item has 3 response options, which range from 0 = "not true or seldom true" to 2 = "true or often true". The 8 syndrome scales to be calculated by summing are "social withdrawal" with scores ranging from 0 - 18, "physical discomfort" with scores ranging from 0 - 18, "anxiety/depression" with scores ranging from 0 - 28, "social difficulties" with scores ranging from 0 - 16, "schizoid/compulsive" scores ranging from 0 - 14, "attention deficits" with scores ranging from 0 - 22, "dissocial behavior" with scores ranging from 0 - 26, "aggressive behavior" with scores ranging from 0 - 40 and "other difficulties" with scores ranging from 0 - 66. A total score can be calculated by summing with scores ranging from 0 - 236. For all scales higher values indicate a higher problem level.
Time frame: baseline and 48 months
Change from baseline parent reported children´s psychiatric symptoms at 60 months
Children´s psychiatric disorders will be assessed by parents´ rating of the German version of the "Child behavior checklist" (CBCL; Achenbach, 1991). The German version of the CBCL consists of 118 items. Each item has 3 response options, which range from 0 = "not true or seldom true" to 2 = "true or often true". The 8 syndrome scales to be calculated by summing are "social withdrawal" with scores ranging from 0 - 18, "physical discomfort" with scores ranging from 0 - 18, "anxiety/depression" with scores ranging from 0 - 28, "social difficulties" with scores ranging from 0 - 16, "schizoid/compulsive" scores ranging from 0 - 14, "attention deficits" with scores ranging from 0 - 22, "dissocial behavior" with scores ranging from 0 - 26, "aggressive behavior" with scores ranging from 0 - 40 and "other difficulties" with scores ranging from 0 - 66. A total score can be calculated by summing with scores ranging from 0 - 236. For all scales higher values indicate a higher problem level.
Time frame: baseline and 60 months
Change from baseline children´s self reported psychiatric symptoms at 12 months
Children´s psychiatric disorders will further be assessed by children´s rating of the German version of the "Youth self report" (YSR; Achenbach, 1991). The German version of the YSR consists of 119 items. Each item has 3 response options, which range from 0 = "not true or seldom true" to 2 = "true or often true". The 8 syndrome scales to be calculated by summing are "social withdrawal" with scores ranging from 0 - 14, "physical discomfort" with scores ranging from 0 - 18, "anxiety/depression" with scores ranging from 0 - 32, "social difficulties" with scores ranging from 0 - 16, "schizoid/compulsive" scores ranging from 0 - 14, "attention deficits" with scores ranging from 0 - 18, "dissocial behavior" with scores ranging from 0 - 22, "aggressive behavior" with scores ranging from 0 - 38 and "other difficulties" with scores ranging from 0 - 40. A total score can be calculated by summing with scores ranging from 0 - 238. For all scales higher values indicate a higher problem level.
Time frame: baseline and 12 months
Change from baseline children´s self reported psychiatric symptoms at 24 months
Children´s psychiatric disorders will further be assessed by children´s rating of the German version of the "Youth self report" (YSR; Achenbach, 1991). The German version of the YSR consists of 119 items. Each item has 3 response options, which range from 0 = "not true or seldom true" to 2 = "true or often true". The 8 syndrome scales to be calculated by summing are "social withdrawal" with scores ranging from 0 - 14, "physical discomfort" with scores ranging from 0 - 18, "anxiety/depression" with scores ranging from 0 - 32, "social difficulties" with scores ranging from 0 - 16, "schizoid/compulsive" scores ranging from 0 - 14, "attention deficits" with scores ranging from 0 - 18, "dissocial behavior" with scores ranging from 0 - 22, "aggressive behavior" with scores ranging from 0 - 38 and "other difficulties" with scores ranging from 0 - 40. A total score can be calculated by summing with scores ranging from 0 - 238. For all scales higher values indicate a higher problem level.
Time frame: baseline and 24 months
Change from baseline children´s self reported psychiatric symptoms at 36 months
Children´s psychiatric disorders will further be assessed by children´s rating of the German version of the "Youth self report" (YSR; Achenbach, 1991). The German version of the YSR consists of 119 items. Each item has 3 response options, which range from 0 = "not true or seldom true" to 2 = "true or often true". The 8 syndrome scales to be calculated by summing are "social withdrawal" with scores ranging from 0 - 14, "physical discomfort" with scores ranging from 0 - 18, "anxiety/depression" with scores ranging from 0 - 32, "social difficulties" with scores ranging from 0 - 16, "schizoid/compulsive" scores ranging from 0 - 14, "attention deficits" with scores ranging from 0 - 18, "dissocial behavior" with scores ranging from 0 - 22, "aggressive behavior" with scores ranging from 0 - 38 and "other difficulties" with scores ranging from 0 - 40. A total score can be calculated by summing with scores ranging from 0 - 238. For all scales higher values indicate a higher problem level.
Time frame: baseline and 36 months
Change from baseline children´s self reported psychiatric symptoms at 48 months
Children´s psychiatric disorders will further be assessed by children´s rating of the German version of the "Youth self report" (YSR; Achenbach, 1991). The German version of the YSR consists of 119 items. Each item has 3 response options, which range from 0 = "not true or seldom true" to 2 = "true or often true". The 8 syndrome scales to be calculated by summing are "social withdrawal" with scores ranging from 0 - 14, "physical discomfort" with scores ranging from 0 - 18, "anxiety/depression" with scores ranging from 0 - 32, "social difficulties" with scores ranging from 0 - 16, "schizoid/compulsive" scores ranging from 0 - 14, "attention deficits" with scores ranging from 0 - 18, "dissocial behavior" with scores ranging from 0 - 22, "aggressive behavior" with scores ranging from 0 - 38 and "other difficulties" with scores ranging from 0 - 40. A total score can be calculated by summing with scores ranging from 0 - 238. For all scales higher values indicate a higher problem level.
Time frame: baseline and 48 months
Change from baseline children´s self reported psychiatric symptoms at 60 months
Children´s psychiatric disorders will further be assessed by children´s rating of the German version of the "Youth self report" (YSR; Achenbach, 1991). The German version of the YSR consists of 119 items. Each item has 3 response options, which range from 0 = "not true or seldom true" to 2 = "true or often true". The 8 syndrome scales to be calculated by summing are "social withdrawal" with scores ranging from 0 - 14, "physical discomfort" with scores ranging from 0 - 18, "anxiety/depression" with scores ranging from 0 - 32, "social difficulties" with scores ranging from 0 - 16, "schizoid/compulsive" scores ranging from 0 - 14, "attention deficits" with scores ranging from 0 - 18, "dissocial behavior" with scores ranging from 0 - 22, "aggressive behavior" with scores ranging from 0 - 38 and "other difficulties" with scores ranging from 0 - 40. A total score can be calculated by summing with scores ranging from 0 - 238. For all scales higher values indicate a higher problem level.
Time frame: baseline and 60 months
Change from baseline children´s structural functioning at 12 months
Children´s structural functioning will be assessed by self-report (children and adolescents aged 10 years and older) using the German structure questionnaire for the "Operationalized psychodynamic diagnostic for children and adolescents" (OPD-KJ2-SF, Goth \& Schmeck, 2016). The OPD-KJ2-SF consists of 81 items. Each item has 5 response options, which range from 0 = "no" to 4 = "yes". The 4 higher order scales to be calculated by summing are "self regulation" with scores ranging from 0 - 64, "identity" with scores ranging from 0 - 96, "interpersonality" with scores ranging from 0 - 100 and "attachment" with scores ranging from 0 - 64. A total score can be calculated ba summing with scores ranging from 0 - 342. For all scales higher values indicate a higher structural impairment.
Time frame: baseline and 12 months
Change from baseline children´s structural functioning at 24 months
Children´s structural functioning will be assessed by self-report (children and adolescents aged 10 years and older) using the German structure questionnaire for the "Operationalized psychodynamic diagnostic for children and adolescents" (OPD-KJ2-SF, Goth \& Schmeck, 2017). The OPD-KJ2-SF consists of 81 items. Each item has 5 response options, which range from 0 = "no" to 4 = "yes". The 4 higher order scales to be calculated by summing are "self regulation" with scores ranging from 0 - 64, "identity" with scores ranging from 0 - 96, "interpersonality" with scores ranging from 0 - 100 and "attachment" with scores ranging from 0 - 64. A total score can be calculated ba summing with scores ranging from 0 - 342. For all scales higher values indicate a higher structural impairment.
Time frame: baseline and 24 months
Change from baseline children´s structural functioning at 36 months
Children´s structural functioning will be assessed by self-report (children and adolescents aged 10 years and older) using the German structure questionnaire for the "Operationalized psychodynamic diagnostic for children and adolescents" (OPD-KJ2-SF, Goth \& Schmeck, 2017). The OPD-KJ2-SF consists of 81 items. Each item has 5 response options, which range from 0 = "no" to 4 = "yes". The 4 higher order scales to be calculated by summing are "self regulation" with scores ranging from 0 - 64, "identity" with scores ranging from 0 - 96, "interpersonality" with scores ranging from 0 - 100 and "attachment" with scores ranging from 0 - 64. A total score can be calculated ba summing with scores ranging from 0 - 342. For all scales higher values indicate a higher structural impairment.
Time frame: baseline and 36 months
Change from baseline children´s structural functioning at 48 months
Children´s structural functioning will be assessed by self-report (children and adolescents aged 10 years and older) using the German structure questionnaire for the "Operationalized psychodynamic diagnostic for children and adolescents" (OPD-KJ2-SF, Goth \& Schmeck, 2017). The OPD-KJ2-SF consists of 81 items. Each item has 5 response options, which range from 0 = "no" to 4 = "yes". The 4 higher order scales to be calculated by summing are "self regulation" with scores ranging from 0 - 64, "identity" with scores ranging from 0 - 96, "interpersonality" with scores ranging from 0 - 100 and "attachment" with scores ranging from 0 - 64. A total score can be calculated ba summing with scores ranging from 0 - 342. For all scales higher values indicate a higher structural impairment.
Time frame: baseline and 48 months
Change from baseline children´s structural functioning at 60 months
Children´s structural functioning will be assessed by self-report (children and adolescents aged 10 years and older) using the German structure questionnaire for the "Operationalized psychodynamic diagnostic for children and adolescents" (OPD-KJ2-SF, Goth \& Schmeck, 2017). The OPD-KJ2-SF consists of 81 items. Each item has 5 response options, which range from 0 = "no" to 4 = "yes". The 4 higher order scales to be calculated by summing are "self regulation" with scores ranging from 0 - 64, "identity" with scores ranging from 0 - 96, "interpersonality" with scores ranging from 0 - 100 and "attachment" with scores ranging from 0 - 64. A total score can be calculated ba summing with scores ranging from 0 - 342. For all scales higher values indicate a higher structural impairment.
Time frame: baseline and 60 months
Change from baseline children´s health related quality of life at 12 months
Children´s health related quality of life will be assessed by children´s (aged 10 years and older) and parents´ rating of the German version of the Kidscreen-27 (Ravens-Sieberer \& the European KIDSCREEN group, 2006). The Kidscreen-27 consists of 27 items. Each item is scored on a 5-point Likert scale ranging from 1 = "not at all true/never" to 5 = "extremely/always". The items are summed up for the 5 specific subscales "physical well-being" with scores ranging from 1 - 20, "psychological well-being" with scores ranging from 1 - 35, "autonomy and parent relation" with scores ranging from 1 - 35, "Social support and peers" with scores ranging from 1 - 40 and "school environment" with scores ranging from 1 - 20. High values represent a high quality of life.
Time frame: baseline and 12 months
Change from baseline children´s health related quality of life at 24 months
Children´s health related quality of life will be assessed by children´s (aged 10 years and older) and parents´ rating of the German version of the Kidscreen-27 (Ravens-Sieberer \& the European KIDSCREEN group, 2006). The Kidscreen-27 consists of 27 items. Each item is scored on a 5-point Likert scale ranging from 1 = "not at all true/never" to 5 = "extremely/always". The items are summed up for the 5 specific subscales "physical well-being" with scores ranging from 1 - 20, "psychological well-being" with scores ranging from 1 - 35, "autonomy and parent relation" with scores ranging from 1 - 35, "Social support and peers" with scores ranging from 1 - 40 and "school environment" with scores ranging from 1 - 20. High values represent a high quality of life.
Time frame: baseline and 24 months
Change from baseline children´s health related quality of life at 36 months
Children´s health related quality of life will be assessed by children´s (aged 10 years and older) and parents´ rating of the German version of the Kidscreen-27 (Ravens-Sieberer \& the European KIDSCREEN group, 2006). The Kidscreen-27 consists of 27 items. Each item is scored on a 5-point Likert scale ranging from 1 = "not at all true/never" to 5 = "extremely/always". The items are summed up for the 5 specific subscales "physical well-being" with scores ranging from 1 - 20, "psychological well-being" with scores ranging from 1 - 35, "autonomy and parent relation" with scores ranging from 1 - 35, "Social support and peers" with scores ranging from 1 - 40 and "school environment" with scores ranging from 1 - 20. High values represent a high quality of life.
Time frame: baseline and 36 months
Change from baseline children´s health related quality of life at 48 months
Children´s health related quality of life will be assessed by children´s (aged 10 years and older) and parents´ rating of the German version of the Kidscreen-27 (Ravens-Sieberer \& the European KIDSCREEN group, 2006). The Kidscreen-27 consists of 27 items. Each item is scored on a 5-point Likert scale ranging from 1 = "not at all true/never" to 5 = "extremely/always". The items are summed up for the 5 specific subscales "physical well-being" with scores ranging from 1 - 20, "psychological well-being" with scores ranging from 1 - 35, "autonomy and parent relation" with scores ranging from 1 - 35, "Social support and peers" with scores ranging from 1 - 40 and "school environment" with scores ranging from 1 - 20. High values represent a high quality of life.
Time frame: baseline and 48 months
Change from baseline children´s health related quality of life at 60 months
Children´s health related quality of life will be assessed by children´s (aged 10 years and older) and parents´ rating of the German version of the Kidscreen-27 (Ravens-Sieberer \& the European KIDSCREEN group, 2006). The Kidscreen-27 consists of 27 items. Each item is scored on a 5-point Likert scale ranging from 1 = "not at all true/never" to 5 = "extremely/always". The items are summed up for the 5 specific subscales "physical well-being" with scores ranging from 1 - 20, "psychological well-being" with scores ranging from 1 - 35, "autonomy and parent relation" with scores ranging from 1 - 35, "Social support and peers" with scores ranging from 1 - 40 and "school environment" with scores ranging from 1 - 20. High values represent a high quality of life.
Time frame: baseline and 60 months
Change from baseline children´s global impairment at 12 months
Children´s global impairment will be assessed by a trained rater external to the project using the german "Skala zur Gesamtbeurteilung von Kindern und Jugendlichen" (SGKJ; Steinhausen, 1985). The SGKJ is a 10 point scale which describes a hypothetic continuum from 10 = mental health ("Outstanding functioning in all areas - e.g. at home, in school, with peers") to 1 = mental disorder ("Needs steady supervision because of severe aggressive or self-destructive behavior, impaired reality testing, communication, cognition, affect or hygiene").
Time frame: baseline and 12 months
Change from baseline children´s global impairment at 24 months
Children´s global impairment will be assessed by a trained rater external to the project using the german "Skala zur Gesamtbeurteilung von Kindern und Jugendlichen" (SGKJ; Steinhausen, 1985). The SGKJ is a 10 point scale which describes a hypothetic continuum from 10 = mental health ("Outstanding functioning in all areas - e.g. at home, in school, with peers") to 1 = mental disorder ("Needs steady supervision because of severe aggressive or self-destructive behavior, impaired reality testing, communication, cognition, affect or hygiene").
Time frame: baseline and 24 months
Change from baseline children´s global impairment at 36 months
Children´s global impairment will be assessed by a trained rater external to the project using the german "Skala zur Gesamtbeurteilung von Kindern und Jugendlichen" (SGKJ; Steinhausen, 1985). The SGKJ is a 10 point scale which describes a hypothetic continuum from 10 = mental health ("Outstanding functioning in all areas - e.g. at home, in school, with peers") to 1 = mental disorder ("Needs steady supervision because of severe aggressive or self-destructive behavior, impaired reality testing, communication, cognition, affect or hygiene").
Time frame: baseline and 36 months
Change from baseline children´s global impairment at 48 months
Children´s global impairment will be assessed by a trained rater external to the project using the german "Skala zur Gesamtbeurteilung von Kindern und Jugendlichen" (SGKJ; Steinhausen, 1985). The SGKJ is a 10 point scale which describes a hypothetic continuum from 10 = mental health ("Outstanding functioning in all areas - e.g. at home, in school, with peers") to 1 = mental disorder ("Needs steady supervision because of severe aggressive or self-destructive behavior, impaired reality testing, communication, cognition, affect or hygiene").
Time frame: baseline and 48 months
Change from baseline children´s global impairment at 60 months
Children´s global impairment will be assessed by a trained rater external to the project using the german "Skala zur Gesamtbeurteilung von Kindern und Jugendlichen" (SGKJ; Steinhausen, 1985). The SGKJ is a 10 point scale which describes a hypothetic continuum from 10 = mental health ("Outstanding functioning in all areas - e.g. at home, in school, with peers") to 1 = mental disorder ("Needs steady supervision because of severe aggressive or self-destructive behavior, impaired reality testing, communication, cognition, affect or hygiene").
Time frame: baseline and 60 months
Change from baseline relational functioning at 12 months
Families´ relational functioning will be rated by a trained rater external to the project using the german version of the "Global assessment of relational functioning scale" (GARF; Saß, Wittchen, \& Zaudig, 1996). The GARF is a 100 point continuous scale with anchor items for every 20 points. It assesses the family functioning from 1 -20 = "the system of relationships within the family is extremely disturbed, continuity of contact and attachment can not be kept up any longer" to 80 - 100 = "the system of relationships in the family ist high functioning".
Time frame: baseline and 12 months
Change from baseline relational functioning at 24 months
Families´ relational functioning will be rated by a trained rater external to the project using the german version of the "Global assessment of relational functioning scale" (GARF; Saß, Wittchen, \& Zaudig, 1996). The GARF is a 100 point continuous scale with anchor items for every 20 points. It assesses the family functioning from 1 -20 = "the system of relationships within the family is extremely disturbed, continuity of contact and attachment can not be kept up any longer" to 80 - 100 = "the system of relationships in the family ist high functioning".
Time frame: baseline and 24 months
Change from baseline relational functioning at 36 months
Families´ relational functioning will be rated by a trained rater external to the project using the german version of the "Global assessment of relational functioning scale" (GARF; Saß, Wittchen, \& Zaudig, 1996). The GARF is a 100 point continuous scale with anchor items for every 20 points. It assesses the family functioning from 1 -20 = "the system of relationships within the family is extremely disturbed, continuity of contact and attachment can not be kept up any longer" to 80 - 100 = "the system of relationships in the family ist high functioning".
Time frame: baseline and 36 months
Change from baseline relational functioning at 48 months
Families´ relational functioning will be rated by a trained rater external to the project using the german version of the "Global assessment of relational functioning scale" (GARF; Saß, Wittchen, \& Zaudig, 1996). The GARF is a 100 point continuous scale with anchor items for every 20 points. It assesses the family functioning from 1 -20 = "the system of relationships within the family is extremely disturbed, continuity of contact and attachment can not be kept up any longer" to 80 - 100 = "the system of relationships in the family ist high functioning".
Time frame: baseline and 48 months
Change from baseline relational functioning at 60 months
Families´ relational functioning will be rated by a trained rater external to the project using the german version of the "Global assessment of relational functioning scale" (GARF; Saß, Wittchen, \& Zaudig, 1996). The GARF is a 100 point continuous scale with anchor items for every 20 points. It assesses the family functioning from 1 -20 = "the system of relationships within the family is extremely disturbed, continuity of contact and attachment can not be kept up any longer" to 80 - 100 = "the system of relationships in the family ist high functioning".
Time frame: baseline and 60 months
Change from baseline children´s global functioning at 12 months
Children´s global functioning will be rated by a trained rater external to the project using the german version of the "Global assessment functioning scale" (GAF; American Psychiatric Association, 2000). The GAF is a 100 point continuous scale with anchor items for every 10 points. Scores between 91 - 100 are given for "Outstanding performance in many activities and coping, no loss of control, being appreciated for many positive qualities, no symptoms". Scores between 1 - 10 are given for "permanent danger of hurting self or others or persistent inability to maintain minimal personal hygiene or serious suicidal attempt with clear expectation of death".
Time frame: baseline and 12 months
Change from baseline children´s global functioning at 24 months
Children´s global functioning will be rated by a trained rater external to the project using the german version of the "Global assessment functioning scale" (GAF; American Psychiatric Association, 2000). The GAF is a 100 point continuous scale with anchor items for every 10 points. Scores between 91 - 100 are given for "Outstanding performance in many activities and coping, no loss of control, being appreciated for many positive qualities, no symptoms". Scores between 1 - 10 are given for "permanent danger of hurting self or others or persistent inability to maintain minimal personal hygiene or serious suicidal attempt with clear expectation of death".
Time frame: baseline and 24 months
Change from baseline children´s global functioning at 36 months
Children´s global functioning will be rated by a trained rater external to the project using the german version of the "Global assessment functioning scale" (GAF; American Psychiatric Association, 2000). The GAF is a 100 point continuous scale with anchor items for every 10 points. Scores between 91 - 100 are given for "Outstanding performance in many activities and coping, no loss of control, being appreciated for many positive qualities, no symptoms". Scores between 1 - 10 are given for "permanent danger of hurting self or others or persistent inability to maintain minimal personal hygiene or serious suicidal attempt with clear expectation of death".
Time frame: baseline and 36 months
Change from baseline children´s global functioning at 48 months
Children´s global functioning will be rated by a trained rater external to the project using the german version of the "Global assessment functioning scale" (GAF; American Psychiatric Association, 2000). The GAF is a 100 point continuous scale with anchor items for every 10 points. Scores between 91 - 100 are given for "Outstanding performance in many activities and coping, no loss of control, being appreciated for many positive qualities, no symptoms". Scores between 1 - 10 are given for "permanent danger of hurting self or others or persistent inability to maintain minimal personal hygiene or serious suicidal attempt with clear expectation of death".
Time frame: baseline and 48 months
Change from baseline children´s global functioning at 60 months
Children´s global functioning will be rated by a trained rater external to the project using the german version of the "Global assessment functioning scale" (GAF; American Psychiatric Association, 2000). The GAF is a 100 point continuous scale with anchor items for every 10 points. Scores between 91 - 100 are given for "Outstanding performance in many activities and coping, no loss of control, being appreciated for many positive qualities, no symptoms". Scores between 1 - 10 are given for "permanent danger of hurting self or others or persistent inability to maintain minimal personal hygiene or serious suicidal attempt with clear expectation of death".
Time frame: baseline and 60 months
Change from baseline health economic data at 12 months
Health economics will be assessed by a trained rater external to the project using the german version of the "Children and adolescent mental health services receipt inventory" (CAMHSRI-DE; Kilian et al., 2009). The CAMHSRI-DE assesses demand (number and duration) of inpatient and outpatient medical services as well as use of medication and demand of special educational establishment or offers in school in the past 12 months.
Time frame: baseline and 12 months
Change from baseline health economic data at 24 months
Health economics will be assessed by a trained rater external to the project using the german version of the "Children and adolescent mental health services receipt inventory" (CAMHSRI-DE; Kilian et al., 2009). The CAMHSRI-DE assesses demand (number and duration) of inpatient and outpatient medical services as well as use of medication and demand of special educational establishment or offers in school in the past 12 months.
Time frame: baseline and 24 months
Change from baseline health economic data at 36 months
Health economics will be assessed by a trained rater external to the project using the german version of the "Children and adolescent mental health services receipt inventory" (CAMHSRI-DE; Kilian et al., 2009). The CAMHSRI-DE assesses demand (number and duration) of inpatient and outpatient medical services as well as use of medication and demand of special educational establishment or offers in school in the past 12 months.
Time frame: baseline and 36 months
Change from baseline health economic data at 48 months
Health economics will be assessed by a trained rater external to the project using the german version of the "Children and adolescent mental health services receipt inventory" (CAMHSRI-DE; Kilian et al., 2009). The CAMHSRI-DE assesses demand (number and duration) of inpatient and outpatient medical services as well as use of medication and demand of special educational establishment or offers in school in the past 12 months.
Time frame: baseline and 48 months
Change from baseline health economic data at 60 months
Health economics will be assessed by a trained rater external to the project using the german version of the "Children and adolescent mental health services receipt inventory" (CAMHSRI-DE; Kilian et al., 2009). The CAMHSRI-DE assesses demand (number and duration) of inpatient and outpatient medical services as well as use of medication and demand of special educational establishment or offers in school in the past 12 months.
Time frame: baseline and 60 months
No study locations are listed for this record.
Start is estimated for Dec 2017; primary completion for Aug 2023, 68 months later.
Of 3,471 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 68 months is above that.
Counting every sponsor, half of 3,569 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Universitätsklinikum Hamburg-Eppendorf →