NCT03722082

Brief Summary

The high hereditary component and the contribution of neurodevelopmental processes in bipolar disorder and schizophrenia means implies the children of these patients are considered a high risk population for both diseases and therefore a very adequate sample for the study of vulnerability markers to both disorders. To date there is no previous literature on the psychological approach of children and adolescents of bipolar or schizophrenic patients. The concept of cognitive reserve (CR) was initially developed in the field of dementia, it assumes that people with the same brain damage may have different clinical manifestations depending on their ability to compensate for this damage, so a greater cognitive reserve will entail a greater capacity to compensate the alterations and difficulties due to the pathology. Enhancing CR in high genetic risk population could help the acquisition of skills that help compensate the clinical, cognitive and neuroimaging alterations and ultimately help in the prevention of the development of pathologies for those with higher risk.This study aims to develop and apply a psychological program in order to enhance cognitive reserve (CR) in child, adolescent and young adults offspring of patients diagnosed with schizophrenia or bipolar disorder (SZBP-OFF).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
173

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2018

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 26, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

May 5, 2022

Status Verified

May 1, 2022

Enrollment Period

3.3 years

First QC Date

October 11, 2018

Last Update Submit

May 4, 2022

Conditions

Bipolar and Related Disorders

Keywords

bipolar disorderschizophreniaoffsprings

Outcome Measures

Primary Outcomes (1)

  • Cognitive reserve

    Changes in cognitive reserve assessed with a specific scale which assesses the most common proposed proxy indicators such as education-occupation' which is assessed taking into account the number of years of obligatory education that subjects completed and parent's educational level; and the lifetime school performance and lifetime participation in leisure, social and physical activities.

    3 months afther the intervention and 12 months after baseline

Secondary Outcomes (7)

  • Hamilton Depression Rating Scale (HDRS-21)

    After the intervention (3 months) and 1 year after baseline

  • Young Mania Rating Scale (YMRS)

    After the intervention (3 months) and 1 year after baseline

  • Bipolar Prodrome Symptom Interview and Scale_Prospective (BPSS_FP)

    12 months after baseline

  • Continuous Performance Test

    After the intervention (3 months) and 12 months after baseline

  • Wisconsin Card Sorting Test

    After the intervention (3 months) and 12 months after baseline

  • +2 more secondary outcomes

Study Arms (2)

Enhancing cognitive reserve intervention

EXPERIMENTAL

This intervention focuses in the improvement of academic skills, the increase of leisure activities and the improvement of neurocognitive functions with the ultimate goal of improving daily functioning. This intervention is based on ecological tasks that will be carried out in two areas, both in the hospital and at home. Most of the techniques are based on: pencil and paper tasks, with audiovisual and virtual reality support, telephone applications and group activities. The groups will be made with parents and children, adolescents and young adults separately being the content of the sessions the same but adapted to the age of the attendees.

Behavioral: Enhancing Cognitive Reserve

Supportive Intervention

PLACEBO COMPARATOR

The participants will not receive any structured intervention focused to enhance cognitive reserve. The therapists will adopt a client-centred focus, meaning that whatever problems the patient presents will be dealt with by providing emotional support and general advise.

Behavioral: Support intervention

Interventions

Enhancing Cognitive ReserveBEHAVIORAL

The intervention is aimed at improving cognitive reserve in offsprings of patients diagnosed with schizophrenia or bipolar disorder. The program is composed of 12 sessions of 60 minutes and will be adapted according the three different age groups (6-12) (13-18) (18-25). Each group will include between 6-to-8 offsprings and conducted by 4 experienced neuropsychologists in both children and adults. The sessions are the following:

Enhancing cognitive reserve intervention
Support interventionBEHAVIORAL

The support group will schedule meetings with the participants in order to talk about their daily life with the possibility to talk about the difficulties they encounter.

Supportive Intervention

Eligibility Criteria

Age6 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children, adolescents or young adults of both genders aged from 6 to 25, with the father and / or mother with schizophrenia, schizoaffective disorder or bipolar disorder according to DSM-IV criteria.
  • Informed consent signed by their parents or legal guardians by adolescents if they are under 12 years old.
  • Children, adolescents or young adults of both genders between the ages of 6 and 25 years.
  • No history of psychotic disorder or bipolar disorder in first and second degree relatives.
  • Consent signed by the parents or legal guardians if they are under 12 years old.

You may not qualify if:

  • Mental retardation with impaired functioning and presence of neurological disorder or history of traumatic brain injury with loss of consciousness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic

Barcelona, Spain

RECRUITING

Related Publications (1)

  • de la Serna E, Montejo L, Sole B, Castro-Fornieles J, Camprodon-Boadas P, Sugranyes G, Rosa-Justicia M, Martinez-Aran A, Vieta E, Vicent-Gil M, Serra-Blasco M, Cardoner N, Torrent C. Effectiveness of enhancing cognitive reserve in children, adolescents and young adults at genetic risk for psychosis: Study protocol for a randomized controlled trial. Span J Psychiatry Ment Health. 2023 Jul-Sep;16(3):184-191. doi: 10.1016/j.rpsm.2021.02.003. Epub 2021 Feb 22.

    PMID: 33631372DERIVED

MeSH Terms

Conditions

Bipolar and Related DisordersBipolar DisorderSchizophrenia

Condition Hierarchy (Ancestors)

Mood DisordersMental DisordersSchizophrenia Spectrum and Other Psychotic Disorders

Central Study Contacts

Carla Torrent, Dr

CONTACT

932275400ctorrent@clinic.ub.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Primary outcome
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 11, 2018

First Posted

October 26, 2018

Study Start

October 1, 2018

Primary Completion

February 1, 2022

Study Completion

June 1, 2022

Last Updated

May 5, 2022

Record last verified: 2022-05

Locations

ES(1)