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PRimary Prevention Of Depression in Offspring of Depressed Parents (PRODO)

Primary Purpose

Depression

Status

Unknown status

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Prevention programme

About this trial

This is an interventional prevention trial for Depression focused on measuring Depression, Prevention, Adolescent, Child, Randomised Controlled Trial, Risk, Cognitive behavioural therapy, Group-based therapy

Eligibility Criteria

8 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Department of Child and Adolescent Psychiatry, Psychosomatics, and PsychotherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Prevention programme

Control (treatment as usual)

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

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).

Full Information

NCT ID

NCT02115880

First Posted

April 7, 2014

Last Updated

May 27, 2014

Sponsor

Ludwig-Maximilians - University of Munich

Collaborators

Bavarian State Ministry of Environment, Public Health and Consumer Protection

1. Study Identification

Unique Protocol Identification Number

NCT02115880

Brief Title

PRimary Prevention Of Depression in Offspring of Depressed Parents

Acronym

PRODO

Official Title

PRimary Prevention Of Depression in Offspring of Depressed Parents

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Unknown status

Study Start Date

May 2014 (undefined)

Primary Completion Date

August 2016 (Anticipated)

Study Completion Date

October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ludwig-Maximilians - University of Munich

Collaborators

Bavarian State Ministry of Environment, Public Health and Consumer Protection

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression

Keywords

Depression, Prevention, Adolescent, Child, Randomised Controlled Trial, Risk, Cognitive behavioural therapy, Group-based therapy

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Prevention programme

Arm Type

Experimental

Arm Title

Control (treatment as usual)

Arm Type

No Intervention

Intervention Type

Behavioral

Intervention Name(s)

Prevention programme

Intervention Description

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.

Primary Outcome Measure Information:

Title

Presence or absence of a depressive episode (child)

Description

Time Frame

T4 (9 months after completion of the programme)

Secondary Outcome Measure Information:

Title

Symptoms of depression (child)

Description

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)

Title

Psychopathological symptoms (child)

Description

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Belinda J Platt, DPhil.

Phone

+498945229032

belinda.platt@med.uni-muenchen.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gerd Schulte-Körne, MD

Organizational Affiliation

Ludwig-Maximilians - University of Munich

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Child and Adolescent Psychiatry, Psychosomatics, and Psychotherapy

City

Munich

State/Province

Bavaria

ZIP/Postal Code

80336

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Belinda J Platt, DPhil.

Phone

+498945229032

belinda.platt@med.uni-muenchen.de

First Name & Middle Initial & Last Name & Degree

Belinda J Platt, DPhil.

12. IPD Sharing Statement

Citations:

PubMed Identifier

21707137

Citation

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.

Results Reference

background

PubMed Identifier

19968378

Citation

Compas 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.

Results Reference

background

PubMed Identifier

34598737

Citation

Lochner 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.

Results Reference

derived

PubMed Identifier

31533676

Citation

Claus 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.

Results Reference

derived

PubMed Identifier

25269863

Citation

Platt 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.

Results Reference

derived

Links:

URL

http://www.kjp.med.uni-muenchen.de/forschung/prodo.php

Description

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