PRimary Prevention Of Depression in Offspring of Depressed Parents

Depression Clinical Trial

— PRODO  

Official title:

PRimary Prevention Of Depression in Offspring of Depressed Parents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02115880
• Other study ID #: LP00216_PRODO
• Secondary ID: LP00216
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: February 2019

Study information

• Verified date: December 2023
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Prevention programme
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.

Locations

Country	Name	City	State
Germany	Department of Child and Adolescent Psychiatry, Psychosomatics, and Psychotherapy	Munich	Bavaria

Sponsors (2)

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

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Symptoms of depression (child)	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).	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)
Secondary	Psychopathological symptoms (child)	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).	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)

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