PRimary Prevention Of Depression in Offspring of Depressed Parents

NCT02115880 | Completed

• 2 other identifiers: LP00216_PRODOLP00216
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Depression

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Symptoms of depression (child)

  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)

  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)

Study Arms (2)

Prevention programme

EXPERIMENTAL

Behavioral: Prevention programme

Control (treatment as usual)

NO INTERVENTION

Interventions

Prevention programme BEHAVIORAL

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.

Prevention programme

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead
• Bavarian State Ministry of Environment, Public Health and Consumer Protection: collaborator

Study Sites (1)

Department of Child and Adolescent Psychiatry, Psychosomatics, and Psychotherapy

Munich, Bavaria, 80336, Germany

Location

Related Publications (6)

• 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.

  PMID: 21707137 BACKGROUND

• 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.

  PMID: 19968378 BACKGROUND

• Lochner 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.

  PMID: 37344778 DERIVED

• 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.

  PMID: 34598737 DERIVED

• 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.

  PMID: 31533676 DERIVED

• 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.

  PMID: 25269863 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Gerd Schulte-Körne, MD

  Ludwig-Maximilians - University of Munich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: April 7, 2014
• First Posted: April 16, 2014
• Study Start: May 1, 2014
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: December 13, 2023

Record last verified: 2023-12

Locations

DE (1)