NCT02101372

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 2, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

October 7, 2015

Status Verified

October 1, 2015

Enrollment Period

1.5 years

First QC Date

March 18, 2014

Last Update Submit

October 6, 2015

Conditions

Psychosis

Keywords

first episode psychosispsychoeducationgroup therapy

Outcome Measures

Primary Outcomes (1)

  • number of relapses

    Change from baseline to 1 -year follow-up and 2 years follow-up

Secondary Outcomes (1)

  • clinical severity

    1year 2 years

Study Arms (2)

treatment as usual

ACTIVE COMPARATOR
Behavioral: treatment as usual

Psychoeducation Group

EXPERIMENTAL
Behavioral: Psychoeducation group treatment

Interventions

treatment as usualBEHAVIORAL

case management

treatment as usual
Psychoeducation group treatmentBEHAVIORAL

Psychoeducation therapy problem solving focus

Psychoeducation Group

Eligibility Criteria

Age14 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital general Universitario Gregorio Marañón

Madrid, Madrid, 28007, Spain

Location

Related Publications (2)

  • 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.

    PMID: 26598473DERIVED

  • 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.

    PMID: 24839887DERIVED

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Celso Arango, MD, PhD

    Hospital General Universitario Gregorio Marañón

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Department

Study Record Dates

First Submitted

March 18, 2014

First Posted

April 2, 2014

Study Start

January 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

October 7, 2015

Record last verified: 2015-10

Locations

ES(1)