Study protocol for a randomised controlled trial of a cognitive-behavioural prevention programme for the children of parents with depression: the PRODO trial

BACKGROUND: Depression is one of the most common psychiatric illnesses worldwide, but is nevertheless preventable. Since the children of parents who have depression are at greatest risk of developing depression themselves, prevention programmes for this population are a major public health priority. Here we report the study protocol of a randomised controlled trial of a group-based psychological intervention for families with i) at least one parent who suffers (or has suffered) from depression and ii) at least one child who has no current or previous psychiatric diagnosis. METHODS/DESIGN: Eligible families will be randomly allocated to receive either a German adaptation of the 12-session cognitive-behavioural Raising Healthy Children intervention (Gesund und glücklich aufwachsen; N = 50), or no intervention (usual care; N = 50). The primary outcome (child diagnosis of an episode of depression) will be assessed at 15-month follow-up. The secondary outcomes (child psychopathological symptoms) will be assessed immediately following completion of the intervention (6-months), as well as at 9- and 15-month follow-up. We hypothesise that children in the intervention condition, compared with those who do not receive the intervention, will show fewer symptoms of psychopathology, and be less likely to meet diagnostic criteria for a depressive episode, at follow-up. DISCUSSION: Despite their elevated risk of developing depression, there is little formal support available for the children of parents with depression. This study provides an important step in the development of more effective depression prevention measures, which are needed if the personal, social and economic burden of depression is to be reduced. TRIAL REGISTRATION: Clinical Trials NCT02115880. Registered April 7 2014.