Clinical trial NCT02115880: PRimary Prevention Of Depression in Offspring of Depressed Parents
Official title: PRimary Prevention Of Depression in Offspring of Depressed Parents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Prevention
Adolescent
Child
Randomised Controlled Trial
Risk
Cognitive behavioural therapy
Group-based therapy
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: Bavarian State Ministry of Environment, Public Health and Consumer Protection
First posted: 2014-04-16
Enrollment: 100
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


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

Primary outcomes:
measure: Presence or absence of a depressive episode (child)
timeFrame: T4 (9 months after completion of the programme)
Secondary outcomes:
measure: Symptoms of depression (child)
timeFrame: 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)
measure: Psychopathological symptoms (child)
timeFrame: 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)
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Child and Adolescent Psychiatry, Psychosomatics, and Psychotherapy
state: Bavaria
Study officials:
affiliation: Ludwig-Maximilians - University of Munich
name: Gerd Schulte-Körne, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.