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Intervention Module AGES (AGES-CM)

Primary Purpose

Psychosis

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
treatment as usual
Psychoeducation group treatment
Sponsored by
Celso Arango
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychosis focused on measuring first episode psychosis, psychoeducation, group therapy

Eligibility Criteria

14 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital general Universitario Gregorio Marañón

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

treatment as usual

Psychoeducation Group

Arm Description

Outcomes

Primary Outcome Measures

number of relapses

Secondary Outcome Measures

clinical severity
PANSS, CGAS, GAF, CGI-I

Full Information

First Posted
March 18, 2014
Last Updated
October 6, 2015
Sponsor
Celso Arango
Collaborators
Comunidad de Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT02101372
Brief Title
Intervention Module AGES
Acronym
AGES-CM
Official Title
Gene and Environment in Schizophrenia- Research Groups in Madrid
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Celso Arango
Collaborators
Comunidad de Madrid

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis
Keywords
first episode psychosis, psychoeducation, group therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
treatment as usual
Arm Type
Active Comparator
Arm Title
Psychoeducation Group
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
treatment as usual
Intervention Description
case management
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation group treatment
Intervention Description
Psychoeducation therapy problem solving focus
Primary Outcome Measure Information:
Title
number of relapses
Time Frame
Change from baseline to 1 -year follow-up and 2 years follow-up
Secondary Outcome Measure Information:
Title
clinical severity
Description
PANSS, CGAS, GAF, CGI-I
Time Frame
1year 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Celso Arango, MD, PhD
Organizational Affiliation
Hospital General Universitario Gregorio Marañón
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital general Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
26598473
Citation
Calvo A, Moreno M, Ruiz-Sancho A, Rapado-Castro M, Moreno C, Sanchez-Gutierrez T, Arango C, Mayoral M. Psychoeducational Group Intervention for Adolescents With Psychosis and Their Families: A Two-Year Follow-Up. J Am Acad Child Adolesc Psychiatry. 2015 Dec;54(12):984-90. doi: 10.1016/j.jaac.2015.09.018. Epub 2015 Oct 13.
Results Reference
derived
PubMed Identifier
24839887
Citation
Calvo A, Moreno M, Ruiz-Sancho A, Rapado-Castro M, Moreno C, Sanchez-Gutierrez T, Arango C, Mayoral M. Intervention for adolescents with early-onset psychosis and their families: a randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2014 Jun;53(6):688-96. doi: 10.1016/j.jaac.2014.04.004. Epub 2014 Apr 18. Erratum In: J Am Acad Child Adolesc Psychiatry. 2015 Dec;54(12):1066.
Results Reference
derived

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Intervention Module AGES

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