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PRimary Prevention Of Depression in Offspring of Depressed Parents

PRimary Prevention Of Depression in Offspring of Depressed Parents

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02115880
Acronym
PRODO
Enrollment
100
Registered
2014-04-16
Start date
2014-05-31
Completion date
2019-02-28
Last updated
2023-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

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

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).

Interventions

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.

Sponsors

Bavarian State Ministry of Environment, Public Health and Consumer Protection
CollaboratorOTHER_GOV
Ludwig-Maximilians - University of Munich
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Presence or absence of a depressive episode (child)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.

Secondary

MeasureTime frameDescription
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)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)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)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).

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026