DepressionPRODONCT02115880
PRimary Prevention Of Depression in Offspring of Depressed Parents
A study testing Prevention programme in people with Depression, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
The purpose of this randomised controlled trial is to see whether a group-based psychological intervention for families can reduce the inflated risk of depression in children and adolescents who have at least one parent who suffers from depression (or who has suffered from depressed in the child's lifetime). Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Prevention programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- May 2014to Feb 2019
- 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 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- At least one parent who meets diagnostic criteria for a current (or past, during the child's lifetime) diagnosis of depression
- The participating child is aged 8-17
- The participating child has an IQ of at least 85
- Both child and parent(s) have adequate German-language skills
- Both child and parents consent to intervention sessions being video-recorded
Who cannot join
- The participating parent(s) has current symptoms of bipolar disorder, psychotic symptoms, personality disorder, substance addiction, or is suicidal
- The participating child meets criteria for a current, or previous, episode of any psychiatric disorder
- The participating child is undergoing or has undergone treatment for depression
- The participating child or parent have serious symptoms of a disorder (or are in crisis) that may hamper their ability to take part in the study
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Child and Adolescent Psychiatry, Psychosomatics, and Psychotherapy
Munich, Bavaria, 80336
About this study
The purpose of this randomised controlled trial is to see whether a group-based psychological intervention for families can reduce the inflated risk of depression in children and adolescents who have at least one parent who suffers from depression (or who has suffered from depressed in the child's lifetime).
- Conditions
- Depression
- Being tested
- Prevention programme
- Keywords
- Depression, Prevention, Adolescent, Child, Randomised Controlled Trial, Risk, Cognitive behavioural therapy, Group-based therapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevention programmeBehavioural
Based on a group- and family-based cognitive behavioural manual developed by Bruce Compas and colleagues in the USA, and adapted for a German sample. The programme is for parents and children and consists of 8 weekly sessions and 4 monthly booster sessions.
| Study group | Role | What they receive |
|---|---|---|
| Prevention programme | Experimental | Not described Receives: Behavioral: Prevention programme |
| Control (treatment as usual) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of a depressive episode (child)
The German version of the Diagnostic Interview for Psychiatric Disorders in Children and Adolescents (Kinder DIPS) will be used to assess whether the child meets the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for a depressive episode.
Measured: T4 (9 months after completion of the programme)
Secondary outcomes (2)
Symptoms of depression (child)
Self-reported symptoms of depression will be collected using the German questionnaires "Depression Inventory for Children and Adolescents" (DIKJ) and Beck Depression Inventory (BDI-II; depending on the child's age).
Measured: Within 2 weeks of the last session of the intervention (T2) as well as 3 months after the intervention (T3) and 9 months after the intervention (T4)
Psychopathological symptoms (child)
More general internal and external psychopathological symptoms will be measured using German versions of the questionnaires "Youth Self-Report" (YSR; child self-report) and "Child Behaviour Checklist" (CBCL; parent-report).
Measured: Within 2 weeks of the last session of the intervention (T2) as well as 3 months after the intervention (T3) and 9 months after the intervention (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionFeb 2019
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Bavarian State Ministry of Environment, Public Health and Consumer Protection
- Responsible party
- Principal investigator, Professor Gerd Schulte-Körne, Ludwig-Maximilians - University of Munich
- Investigators
- Gerd Schulte-Körne, MD, Principal investigator, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02115880
- Sponsor's protocol ID
- LP00216_PRODO
- Other IDs
- LP00216
- Acronym
- PRODO
- Status last verified
- Dec 2023
- First submitted
- 7 Apr 2014
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Compas BE, Forehand R, Thigpen JC, Keller G, Hardcastle EJ, Cole DA, Potts J, Watson KH, Rakow A, Colletti C, Reeslund K, Fear J, Garai E, McKee L, Merchant MJ, Roberts L. Family group cognitive-behavioral preventive intervention for families of depressed parents: 18- and 24-month outcomes. J Consult Clin Psychol. 2011 Aug;79(4):488-99. doi: 10.1037/a0024254.
PubMed 21707137Compas BE, Forehand R, Keller G, Champion JE, Rakow A, Reeslund KL, McKee L, Fear JM, Colletti CJ, Hardcastle E, Merchant MJ, Roberts L, Potts J, Garai E, Coffelt N, Roland E, Sterba SK, Cole DA. Randomized controlled trial of a family cognitive-behavioral preventive intervention for children of depressed parents. J Consult Clin Psychol. 2009 Dec;77(6):1007-20. doi: 10.1037/a0016930.
PubMed 19968378Lochner J, Platt B, Starman-Wohrle K, Takano K, Engelmann L, Voggt A, Loy F, Bley M, Winogradow D, Hammerle S, Neumeier E, Wermuth I, Schmitt K, Oort F, Schulte-Korne G. A randomized controlled trial of a preventive intervention for the children of parents with depression: mid-term effects, mediators and moderators. BMC Psychiatry. 2023 Jun 21;23(1):455. doi: 10.1186/s12888-023-04926-2.
PubMed 37344778Lochner J, Starman-Wohrle K, Takano K, Engelmann L, Voggt A, Loy F, Bley M, Winogradow D, Hammerle S, Neumeier E, Wermuth I, Schmitt K, Oort F, Schulte-Korne G, Platt B. A randomised controlled trial of a family-group cognitive-behavioural (FGCB) preventive intervention for the children of parents with depression: short-term effects on symptoms and possible mechanisms. Child Adolesc Psychiatry Ment Health. 2021 Oct 1;15(1):54. doi: 10.1186/s13034-021-00394-2.
PubMed 34598737Claus N, Marzano L, Loechner J, Starman K, Voggt A, Loy F, Wermuth I, Haemmerle S, Engelmann L, Bley M, Schulte-Koerne G, Platt B. Qualitative evaluation of a preventive intervention for the offspring of parents with a history of depression. BMC Psychiatry. 2019 Sep 18;19(1):290. doi: 10.1186/s12888-019-2273-6.
PubMed 31533676Platt B, Pietsch K, Krick K, Oort F, Schulte-Korne G. Study protocol for a randomised controlled trial of a cognitive-behavioural prevention programme for the children of parents with depression: the PRODO trial. BMC Psychiatry. 2014 Sep 18;14:263. doi: 10.1186/s12888-014-0263-2.
PubMed 25269863
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRimary Prevention Of Depression in Offspring of Depressed Parents
- ClinicalTrials.gov ID
- NCT02115880
- Acronym / sponsor ID
- PRODO / LP00216_PRODO
- Conditions
- Depression
- Keywords
- Depression, Prevention, Adolescent, Child, Randomised Controlled Trial, Risk, Cognitive behavioural therapy, Group-based therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- Bavarian State Ministry of Environment, Public Health and Consumer Protection
- Study start
- May 2014
- Primary completion
- Feb 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 16 Apr 2014 (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 randomised controlled trial is to see whether a group-based psychological intervention for families can reduce the inflated risk of depression in children and adolescents who have at least one parent who suffers from depression (or who has suffered from depressed in the child's lifetime).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prevention programme | Experimental | Behavioral: Prevention programme |
| Control (treatment as usual) | No intervention | – |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- At least one parent who meets diagnostic criteria for a current (or past, during the child's lifetime) diagnosis of depression
- The participating child is aged 8-17
- The participating child has an IQ of at least 85
- Both child and parent(s) have adequate German-language skills
- Both child and parents consent to intervention sessions being video-recorded
Key exclusion criteria (4 listed)
- The participating parent(s) has current symptoms of bipolar disorder, psychotic symptoms, personality disorder, substance addiction, or is suicidal
- The participating child meets criteria for a current, or previous, episode of any psychiatric disorder
- The participating child is undergoing or has undergone treatment for depression
- The participating child or parent have serious symptoms of a disorder (or are in crisis) that may hamper their ability to take part in the study
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 |
|---|---|---|
| Prevention programmeBased on a group- and family-based cognitive behavioural manual developed by Bruce Compas and colleagues in the USA, and adapted for a German sample. The programme is for parents and children and consists of 8 weekly sessions and 4 monthly booster sessions. | Behavioural | Prevention programme |
Primary outcome
Presence or absence of a depressive episode (child)
Time frame: T4 (9 months after completion of the programme)
The German version of the Diagnostic Interview for Psychiatric Disorders in Children and Adolescents (Kinder DIPS) will be used to assess whether the child meets the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for a depressive episode.
2 secondary outcomes
Symptoms of depression (child)
Time frame: Within 2 weeks of the last session of the intervention (T2) as well as 3 months after the intervention (T3) and 9 months after the intervention (T4)
Psychopathological symptoms (child)
Time frame: Within 2 weeks of the last session of the intervention (T2) as well as 3 months after the intervention (T3) and 9 months after the intervention (T4)
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 13 Dec 2023.
- Background: PubMed 21707137Compas BE, Forehand R, Thigpen JC, Keller G, Hardcastle EJ, Cole DA, Potts J, Watson KH, Rakow A, Colletti C, Reeslund K, Fear J, Garai E, McKee L, Merchant MJ, Roberts L. Family group cognitive-behavioral preventive intervention for families of depressed parents: 18- and 24-month outcomes. J Consult Clin Psychol. 2011 Aug;79(4):488-99. doi: 10.1037/a0024254.
- Background: PubMed 19968378Compas BE, Forehand R, Keller G, Champion JE, Rakow A, Reeslund KL, McKee L, Fear JM, Colletti CJ, Hardcastle E, Merchant MJ, Roberts L, Potts J, Garai E, Coffelt N, Roland E, Sterba SK, Cole DA. Randomized controlled trial of a family cognitive-behavioral preventive intervention for children of depressed parents. J Consult Clin Psychol. 2009 Dec;77(6):1007-20. doi: 10.1037/a0016930.
- Derived from this study: PubMed 37344778Lochner J, Platt B, Starman-Wohrle K, Takano K, Engelmann L, Voggt A, Loy F, Bley M, Winogradow D, Hammerle S, Neumeier E, Wermuth I, Schmitt K, Oort F, Schulte-Korne G. A randomized controlled trial of a preventive intervention for the children of parents with depression: mid-term effects, mediators and moderators. BMC Psychiatry. 2023 Jun 21;23(1):455. doi: 10.1186/s12888-023-04926-2.
- Derived from this study: PubMed 34598737Lochner J, Starman-Wohrle K, Takano K, Engelmann L, Voggt A, Loy F, Bley M, Winogradow D, Hammerle S, Neumeier E, Wermuth I, Schmitt K, Oort F, Schulte-Korne G, Platt B. A randomised controlled trial of a family-group cognitive-behavioural (FGCB) preventive intervention for the children of parents with depression: short-term effects on symptoms and possible mechanisms. Child Adolesc Psychiatry Ment Health. 2021 Oct 1;15(1):54. doi: 10.1186/s13034-021-00394-2.
- Derived from this study: PubMed 31533676Claus N, Marzano L, Loechner J, Starman K, Voggt A, Loy F, Wermuth I, Haemmerle S, Engelmann L, Bley M, Schulte-Koerne G, Platt B. Qualitative evaluation of a preventive intervention for the offspring of parents with a history of depression. BMC Psychiatry. 2019 Sep 18;19(1):290. doi: 10.1186/s12888-019-2273-6.
- Derived from this study: PubMed 25269863Platt B, Pietsch K, Krick K, Oort F, Schulte-Korne G. Study protocol for a randomised controlled trial of a cognitive-behavioural prevention programme for the children of parents with depression: the PRODO trial. BMC Psychiatry. 2014 Sep 18;14:263. doi: 10.1186/s12888-014-0263-2.
- Related InfoLink provided by the sponsor.
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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.
Gerd Schulte-Körne, MD principal investigator
Ludwig-Maximilians - University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevention programme in people with Depression, run by Ludwig-Maximilians - University of Munich 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 5 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: finished, as of the sponsor's last update on 13 Dec 2023. 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?
Presence or absence of a depressive episode (child) (time frame: T4 (9 months after completion of the programme)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02115880, which also lists 6 linked publications.
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 13 Dec 2023.