Intervention Module AGES

Psychosis Clinical Trial

— AGES-CM  

Official title:

Gene and Environment in Schizophrenia- Research Groups in Madrid

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02101372
• Other study ID #: P2010/BMD-2422
• Status: Completed
• Phase: N/A
• First received: March 18, 2014
• Last updated: October 6, 2015
• Start date: January 2013
• Est. completion date: July 2014

Study information

• Verified date: October 2015
• Source: Hospital General Universitario Gregorio Marañon
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

The AGES-CM consortium aims to study the interaction between the polymorphisms of the candidate genes related with neurodevelopment, neurotransmission, brain progressive changes, cognitive functioning and stressful life events (prospective- and retrospectively assessed) and the association of the interactions with structural and functional brain measures, neuropsychological performance, biochemical and oxidative status in both in patients and controls. The investigators study aimed to examine the effectiveness of a parallel, structured, and specific psychoeducational group intervention (PE) for adolescent patients and their families by comparing it with treatment as usual).

Description:

Objective: To assess the effectiveness of a structured psychoeducational group intervention for adolescents with early onset psychosis and their families. The intervention was implemented in parallel in 2 separate groups, by focusing specifically on problem solving strategies and structured psychosis-related information to manage daily life hassles associated with the disease in order to manage crises and prevent relapses.

Method: The investigators performed a 9-month, randomized, rater-blind clinical trial involving adolescent patients with early onset psychosis and 1 or both of their parents. The primary outcomes were number of hospitalizations, days of hospitalization, and visits to the emergency department. The secondary outcome measures were clinical variables and family environment and well being.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 19 Years

Eligibility

Inclusion Criteria:

• The presence of at least one positive psychotic symptom (delusions or hallucinations)

• Before age 18 diagnosed by DSM-IV

• Aged between 14 and 19 years and lived at home with 1 or both parents, caregivers, or legal guardians.

Exclusion Criteria:

• The exclusion criteria were patient's drug abuse or dependence at the time of the intervention (drug use was not an exclusion criterion), the presence of any neurological developmental disorder or mental retardation and inability to engage in conversation or read in Spanish that may interfere with the progress of group treatment.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychosis

Intervention

Behavioral:
• treatment as usual
case management
• Psychoeducation group treatment
Psychoeducation therapy problem solving focus

Locations

Country	Name	City	State
Spain	Hospital general Universitario Gregorio Marañón	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Celso Arango	Comunidad de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of relapses		Change from baseline to 1 -year follow-up and 2 years follow-up	No
Secondary	clinical severity	PANSS, CGAS, GAF, CGI-I	1year 2 years	No

External Links

•   Link