Depression, AnxietyNCT03333239
Short-term, Long-term and Cost-effectiveness of Treating Depression and Anxiety Disorders in Children and Adolescents
A study testing psychodynamic psychotherapy, cognitive behavioral psychotherapy and psychodynamic family intervention in people with Depression, Anxiety, run by Universitätsklinikum Hamburg-Eppendorf.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- psychodynamic psychotherapy, cognitive behavioral psychotherapy and psychodynamic family intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- No sites listed yet
- Study dates
- 22 Dec 2017to Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- diagnosis of a depressive disorder (ICD-10; F30-F39) or an anxiety disorder (ICD-10; F40-F42)
- informed consent
- ages 8 to 16 years
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Short-term, Long-term and Cost-effectiveness of Treating Depression and Anxiety Disorders in Children and Adolescents - a Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Depression, Anxiety
- Being tested
- psychodynamic psychotherapy, cognitive behavioral psychotherapy, psychodynamic family intervention
- Keywords
- childhood and adolescence
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychodynamic psychotherapyBehavioural
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)
cognitive behavioral psychotherapyBehavioural
the interventions follow the published in german manuals: Depression (Ihle, Groen, Walter, Esser, \& Petermann, 2012) and Soziale Ängste und Leistungsängste (Büch, Döpfner, \& Petermann, 2015)
psychodynamic family interventionBehavioural
the intervention follows an adapted version of the manual: Chimp´s - Children of mentally ill parents (Wiegand-Gefe, Halverscheid, \& Plass, 2011)
| Study group | Role | What they receive |
|---|---|---|
| psychodynamic psychotherapy | Experimental | Not described Receives: Behavioral: psychodynamic psychotherapy |
| cognitive behavioral psychotherapy | Experimental | Not described Receives: Behavioral: cognitive behavioral psychotherapy |
| psychodynamic family intervention | Active comparator | Not described Receives: Behavioral: psychodynamic family intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline and 60 months
Secondary outcomes (50)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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").
Measured: 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").
Measured: 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").
Measured: 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").
Measured: 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").
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline and 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start22 Dec 2017 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bremen
- Responsible party
- Principal investigator, Silke Wiegand-Grefe, Prof. Dr., Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Silke Wiegand-Grefe, Prof. Dr., Principal investigator, UKE Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03333239
- Sponsor's protocol ID
- vakjp_2
- Status last verified
- Dec 2017
- First submitted
- 4 Sep 2017
- Last updated
- 21 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term, Long-term and Cost-effectiveness of Treating Depression and Anxiety Disorders in Children and Adolescents - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03333239
- Acronym / sponsor ID
- vakjp_2
- Conditions
- Depression, Anxiety
- Keywords
- childhood and adolescence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- University of Bremen
- Study start
- 22 Dec 2017 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| psychodynamic psychotherapy | Experimental | Behavioral: psychodynamic psychotherapy |
| cognitive behavioral psychotherapy | Experimental | Behavioral: cognitive behavioral psychotherapy |
| psychodynamic family intervention | Active comparator | Behavioral: psychodynamic family intervention |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- diagnosis of a depressive disorder (ICD-10; F30-F39) or an anxiety disorder (ICD-10; F40-F42)
- informed consent
- ages 8 to 16 years
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| psychodynamic psychotherapythe intervention follows the published in german manual: Psychoanalytische Behandlung von Kindern und Jugendlichen mit Angststörungen und Depressionen: Behandlungsmanual (Baumeister-Duru, Hofmann, Timmermann \& Wulf, 2013) | Behavioural | psychodynamic psychotherapy |
| cognitive behavioral psychotherapythe interventions follow the published in german manuals: Depression (Ihle, Groen, Walter, Esser, \& Petermann, 2012) and Soziale Ängste und Leistungsängste (Büch, Döpfner, \& Petermann, 2015) | Behavioural | cognitive behavioral psychotherapy |
| psychodynamic family interventionthe intervention follows an adapted version of the manual: Chimp´s - Children of mentally ill parents (Wiegand-Gefe, Halverscheid, \& Plass, 2011) | Behavioural | psychodynamic family intervention |
Primary outcome
Change from baseline children´s psychiatric symptomatology at 12 months
Time frame: baseline and 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.
Change from baseline children´s psychiatric symptomatology at 24 months
Time frame: baseline and 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.
Change from baseline children´s psychiatric symptomatology at 36 months
Time frame: baseline and 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.
Change from baseline children´s psychiatric symptomatology at 48 months
Time frame: baseline and 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.
Change from baseline children´s psychiatric symptomatology at 60 months
Time frame: baseline and 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.
50 secondary outcomes
Change from baseline children´s depressive symptomatology at 12 months
Time frame: baseline and 12 months
Change from baseline children´s depressive symptomatology at 24 months
Time frame: baseline and 24 months
Change from baseline children´s depressive symptomatology at 36 months
Time frame: baseline and 36 months
Change from baseline children´s depressive symptomatology at 48 months
Time frame: baseline and 48 months
Change from baseline children´s depressive symptomatology at 60 months
Time frame: baseline and 60 months
Change from baseline children´s anxiety at 12 months
Time frame: baseline and 12 months
Change from baseline children´s anxiety at 24 months
Time frame: baseline and 24 months
Change from baseline children´s anxiety at 36 months
Time frame: baseline and 36 months
Change from baseline children´s anxiety at 48 months
Time frame: baseline and 48 months
Change from baseline children´s anxiety at 60 months
Time frame: baseline and 60 months
Change from baseline parent reported children´s psychiatric symptoms at 12 months
Time frame: baseline and 12 months
Change from baseline parent reported children´s psychiatric symptoms at 24 months
Time frame: baseline and 24 months
Change from baseline parent reported children´s psychiatric symptoms at 36 months
Time frame: baseline and 36 months
Change from baseline parent reported children´s psychiatric symptoms at 48 months
Time frame: baseline and 48 months
Change from baseline parent reported children´s psychiatric symptoms at 60 months
Time frame: baseline and 60 months
Change from baseline children´s self reported psychiatric symptoms at 12 months
Time frame: baseline and 12 months
Change from baseline children´s self reported psychiatric symptoms at 24 months
Time frame: baseline and 24 months
Change from baseline children´s self reported psychiatric symptoms at 36 months
Time frame: baseline and 36 months
Change from baseline children´s self reported psychiatric symptoms at 48 months
Time frame: baseline and 48 months
Change from baseline children´s self reported psychiatric symptoms at 60 months
Time frame: baseline and 60 months
Change from baseline children´s structural functioning at 12 months
Time frame: baseline and 12 months
Change from baseline children´s structural functioning at 24 months
Time frame: baseline and 24 months
Change from baseline children´s structural functioning at 36 months
Time frame: baseline and 36 months
Change from baseline children´s structural functioning at 48 months
Time frame: baseline and 48 months
Change from baseline children´s structural functioning at 60 months
Time frame: baseline and 60 months
Change from baseline children´s health related quality of life at 12 months
Time frame: baseline and 12 months
Change from baseline children´s health related quality of life at 24 months
Time frame: baseline and 24 months
Change from baseline children´s health related quality of life at 36 months
Time frame: baseline and 36 months
Change from baseline children´s health related quality of life at 48 months
Time frame: baseline and 48 months
Change from baseline children´s health related quality of life at 60 months
Time frame: baseline and 60 months
Change from baseline children´s global impairment at 12 months
Time frame: baseline and 12 months
Change from baseline children´s global impairment at 24 months
Time frame: baseline and 24 months
Change from baseline children´s global impairment at 36 months
Time frame: baseline and 36 months
Change from baseline children´s global impairment at 48 months
Time frame: baseline and 48 months
Change from baseline children´s global impairment at 60 months
Time frame: baseline and 60 months
Change from baseline relational functioning at 12 months
Time frame: baseline and 12 months
Change from baseline relational functioning at 24 months
Time frame: baseline and 24 months
Change from baseline relational functioning at 36 months
Time frame: baseline and 36 months
Change from baseline relational functioning at 48 months
Time frame: baseline and 48 months
Change from baseline relational functioning at 60 months
Time frame: baseline and 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silke Wiegand-Grefe, Prof. Dr. principal investigator
UKE Universitätsklinikum Hamburg-Eppendorf
Questions about this trial
What is this clinical trial studying?
A study testing psychodynamic psychotherapy, cognitive behavioral psychotherapy and psychodynamic family intervention in people with Depression, Anxiety, run by Universitätsklinikum Hamburg-Eppendorf.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silke Wiegand-Grefe, Prof. Dr. (+49-40-741053603, s.wiegand-grefe@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline children´s psychiatric symptomatology at 12 months (time frame: baseline and 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2017.