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

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 Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: Prevention programme

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Belinda J Platt, DPhil.; Phone Number: +498945229032; Email: belinda.platt@med.uni-muenchen.de

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 80336
      • Department of Child and Adolescent Psychiatry, Psychosomatics, and Psychotherapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prevention programme	Behavioral: Prevention programme; 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.
No Intervention: Control (treatment as usual)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	T4 (9 months after completion of the programme)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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)

Collaborators and Investigators

• Sponsor: Ludwig-Maximilians - University of Munich
• Collaborators: Bavarian State Ministry of Environment, Public Health and Consumer Protection
• Investigators: Principal Investigator: Gerd Schulte-Körne, MD, Ludwig-Maximilians - University of Munich

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: April 7, 2014
• First Submitted That Met QC Criteria: April 14, 2014
• First Posted (Estimated): April 16, 2014

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Adolescent; Depression; Child; Prevention; Cognitive behavioural therapy; Risk; Randomised Controlled Trial; Group-based therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: LP00216_PRODO; LP00216 (Other Grant/Funding Number: Bavarian State Ministry of Environment, Public Health and Consumer Protection)