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Completed

NCT Number: NCT02115880

PRimary Prevention Of Depression in Offspring of Depressed Parents

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).

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Child and Adolescent Psychiatry, Psychosomatics, and Psychotherapy

Munich, Bavaria, 80336, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Presence or absence of a depressive episode (child)

    Time frame: 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 outcomes

  1. Symptoms of depression (child)

    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)

    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).

  2. Psychopathological symptoms (child)

    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)

    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).

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Collaborators

  • Bavarian State Ministry of Environment, Public Health and Consumer Protection

Registry information

Acronym: PRODO

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Apr 16, 2014
Registry last updated
Dec 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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