Intervention Module AGES

Not Applicable

Completed

• Conditions: Psychosis
• Interventions: Behavioral: Psychoeducation group treatment; Behavioral: treatment as usual

• Registration Number: NCT02101372
• Lead Sponsor: Celso Arango

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-03-18
• Study First Submitted QC: 2014-03-28
• Study First Posted: 2014-04-02
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-06
• Last Update Posted: 2015-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psychoeducation Group	Psychoeducation group treatment	-
treatment as usual	treatment as usual	-

Primary Outcome Measures

Name	Time	Method
number of relapses	Change from baseline to 1 -year follow-up and 2 years follow-up

Secondary Outcome Measures

Name	Time	Method
clinical severity	1year 2 years	PANSS, CGAS, GAF, CGI-I

Trial Locations

Locations (1)

Hospital general Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain