Intervention Module AGES

Study Overview
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Brief Summary
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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
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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.

Official Title
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Gene and Environment in Schizophrenia- Research Groups in Madrid

Conditions
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Psychosis

Intervention / Treatment
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* Behavioral: treatment as usual
* Behavioral: Psychoeducation group treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: treatment as usual<br> | Behavioral: treatment as usual<br>* case management<br>|
| Experimental: Psychoeducation Group<br> | Behavioral: Psychoeducation group treatment<br>* Psychoeducation therapy problem solving focus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of relapses |  | Change from baseline to 1 -year follow-up and 2 years follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical severity | PANSS, CGAS, GAF, CGI-I | 1year 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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first episode psychosis, psychoeducation, group therapy