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Intervention Module AGES (AGES-CM)

C

Celso Arango

Status

Completed

Conditions

Psychosis

Treatments

Behavioral: treatment as usual
Behavioral: Psychoeducation group treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT02101372
P2010/BMD-2422

Details and patient eligibility

About

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).

Full 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.

Enrollment

55 patients

Sex

All

Ages

14 to 19 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

55 participants in 2 patient groups

treatment as usual
Active Comparator group
Treatment:
Behavioral: treatment as usual
Psychoeducation Group
Experimental group
Treatment:
Behavioral: Psychoeducation group treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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