Anxiety SymptomsNCT00564239
Psychological Prevention of Internalizing Disorders
A study testing Cognitive Behavioral Group Therapy in people with Anxiety Symptoms and Depressive Symptoms, run by Philipps University Marburg at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether cognitive-behavioral group prevention (CBT-G) for german children is effective and to what extent parental group training moderates outcome. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Anxiety Symptoms, Depressive Symptoms, Somatoform Symptoms
- What is being tested?
- Cognitive Behavioral Group Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2007to May 2009
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age 8- 12 years and
- anxiety symptoms and/or
- depressive symptoms and/or
- somatoform symptoms
Who cannot join
- psychiatric disorder according to ICD-10/ DSM-IV-TR requiring individual psychotherapy
- IQ < 85
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institut für Verhaltenstherapie und -medizin (IVV)
Marburg, Hesse, D-35039
About this study
Official title: Efficacy of Child-centered Cognitive-Behavioral Prevention of Internalizing Disorders and the Impact of Simultaneous Parent Training
The purpose of this study is to determine whether cognitive-behavioral group prevention (CBT-G) for german children is effective and to what extent parental group training moderates outcome.
Read the detailed description
Internalizing disorders represent a large group of psychological disorders among children who are referred to psychological treatment. Anxiety, Depression and somatoform disorders in children and adolescents increase the risk of mental disorders in adulthood. Some english programs have proved the efficacy of CBT-G prevention.This study will test the efficacy of CBT-G in German children. The role of parental involvement is currently subject to scientific discussions. The impact of an additional parent-group training will be investigated.
- Conditions
- Anxiety Symptoms, Depressive Symptoms, Somatoform Symptoms
- Being tested
- Cognitive Behavioral Group Therapy
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Group TherapyBehavioural
12 children group sessions, 8 parent group sessions
Cognitive Behavioral Group TherapyBehavioural
12 children group sessions
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Behavioral: Cognitive Behavioral Group Therapy |
| B | Active comparator | Not described Receives: Behavioral: Cognitive Behavioral Group Therapy |
| C | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Behavior Checklist (german version)
Measured: 3, 6, 18 months
Secondary outcomes (6)
Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen (ILK)- Assessment of life quality, parent and child versions
Measured: 3, 6, 18 months
Spence Children's Anxiety Scale (SCAS)
Measured: 3, 6, 18 months
Depressionsinventar für Kinder- und Jugendliche (DIKJ), german depression inventory based on CDI
Measured: 3, 6, 18 months
Giessener Beschwerdebogen für Kinder- und Jugendliche (GBB-KJ), report of somatic symptoms, parent and child versions
Measured: 3, 6, 18 months
Culture Fair Intelligence Test (CFT 20-R)
Measured: initially
Symptom-Checklist (SCL-90-R), german version
Measured: 3, 6, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety SymptomsStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Behavioral-Therapy and -Medicine at the Philipps University Marburg, Dept. of Child and Adolescent Psychiatry, Philipps University Marburg
- Responsible party
- Principal investigator, Jan Pauschardt, Philipps University Marburg
- Investigators
- Jan Pauschardt, Dr., Principal investigator, Philipps University MarburgSylvia D Eimecke, Dr., Principal investigator, Philipps University MarburgFritz Mattejat, PhD, Study director, Philipps University Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00564239
- Sponsor's protocol ID
- IVV-001-2007
- Other IDs
- IVV-001-2007
- Status last verified
- Apr 2018
- First submitted
- 26 Nov 2007
- Last updated
- 30 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Child-centered Cognitive-Behavioral Prevention of Internalizing Disorders and the Impact of Simultaneous Parent Training
- ClinicalTrials.gov ID
- NCT00564239
- Acronym / sponsor ID
- IVV-001-2007
- Conditions
- Anxiety Symptoms, Depressive Symptoms, Somatoform Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Collaborators
- Institute of Behavioral-Therapy and -Medicine at the Philipps University Marburg, Dept. of Child and Adolescent Psychiatry, Philipps University Marburg
- Study start
- Nov 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 27 Nov 2007 (estimated)
- 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 purpose of this study is to determine whether cognitive-behavioral group prevention (CBT-G) for german children is effective and to what extent parental group training moderates outcome.
Detailed description
Internalizing disorders represent a large group of psychological disorders among children who are referred to psychological treatment. Anxiety, Depression and somatoform disorders in children and adolescents increase the risk of mental disorders in adulthood. Some english programs have proved the efficacy of CBT-G prevention.This study will test the efficacy of CBT-G in German children. The role of parental involvement is currently subject to scientific discussions. The impact of an additional parent-group training will be investigated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Behavioral: Cognitive Behavioral Group Therapy |
| B | Active comparator | Behavioral: Cognitive Behavioral Group Therapy |
| C | No intervention | – |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- age 8- 12 years and
- anxiety symptoms and/or
- depressive symptoms and/or
- somatoform symptoms
Key exclusion criteria (2 listed)
- psychiatric disorder according to ICD-10/ DSM-IV-TR requiring individual psychotherapy
- IQ < 85
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 |
|---|---|---|
| Cognitive Behavioral Group Therapy12 children group sessions, 8 parent group sessions | Behavioural | A |
| Cognitive Behavioral Group Therapy12 children group sessions | Behavioural | B |
Primary outcome
Child Behavior Checklist (german version)
Time frame: 3, 6, 18 months
6 secondary outcomes
Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen (ILK)- Assessment of life quality, parent and child versions
Time frame: 3, 6, 18 months
Spence Children's Anxiety Scale (SCAS)
Time frame: 3, 6, 18 months
Depressionsinventar für Kinder- und Jugendliche (DIKJ), german depression inventory based on CDI
Time frame: 3, 6, 18 months
Giessener Beschwerdebogen für Kinder- und Jugendliche (GBB-KJ), report of somatic symptoms, parent and child versions
Time frame: 3, 6, 18 months
Culture Fair Intelligence Test (CFT 20-R)
Time frame: initially
Symptom-Checklist (SCL-90-R), german version
Time frame: 3, 6, 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2018.
Related trials for Anxiety Symptoms
Not yet recruiting
Building Resilience Through Anxiety Virtual Education in PICU Survivors
Critical Illness Recovery, Mental Health
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Recruiting
Modulating Escape Using Focused Ultrasound
Anxiety Disorders
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
Recruiting
Stress and Anxiety Effects on Valuation
Reward Value Level
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.
Jan Pauschardt, Dr. principal investigator
Philipps University Marburg
Sylvia D Eimecke, Dr. principal investigator
Philipps University Marburg
Fritz Mattejat, PhD study director
Philipps University Marburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Group Therapy in people with Anxiety Symptoms and Depressive Symptoms, run by Philipps University Marburg at 1 site in Germany.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 30 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Behavior Checklist (german version) (time frame: 3, 6, 18 months). 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 30 Apr 2018.