Evaluation of a Clinical Transitional Program in Autism

NCT ID: NCT03392870

Last Updated: 2018-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2019-04-30

Brief Summary

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Clinical trial without drug, randomized: Comparison of a specific and integrative clinical protocol for young adults with autism to usual treatment. It will include both low and high-functioning participants.

Detailed Description

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Conditions

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Autism Spectrum Disorder (ASD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
A researcher will be masked for group aleatorization (active, group) in order to unbiasedly evaluate outcomes which require subjective assesment of functionality.

Study Groups

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TAVA-ACTIVE

Integrative interventional programme. It involves high-frequency multidisciplinary intervention: nursing, psychology, psychiatry and social services. A psychotherapeutic group would be offered to those patients with an intelligence quotient\>70, verbal communication and no behavioural alterations.

Group Type EXPERIMENTAL

Integrative interventional programme

Intervention Type OTHER

The active condition includes specialized, multidisciplinary and intensive individual (weekly to monthly) or group interventions (weekly). Only high-functioning subjects will be considered for group interventions.

CONTROL

As usual

Group Type ACTIVE_COMPARATOR

As usual

Intervention Type OTHER

The control group will follow treatment as usual, consisting in conventional general psychiatrist/psychologist clinical follow-up. The frequency varies between 3-6 months or 15-21 days if worsening of symptoms or comorbid conditions.

Interventions

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Integrative interventional programme

The active condition includes specialized, multidisciplinary and intensive individual (weekly to monthly) or group interventions (weekly). Only high-functioning subjects will be considered for group interventions.

Intervention Type OTHER

As usual

The control group will follow treatment as usual, consisting in conventional general psychiatrist/psychologist clinical follow-up. The frequency varies between 3-6 months or 15-21 days if worsening of symptoms or comorbid conditions.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* ASD diagnosis
* Previous follow-up by child and adolescent psychiatry department at Corporació Sanitària Parc Taulí (CSPT)

Exclusion Criteria

\- Living in a disabled residential setting
Minimum Eligible Age

18 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Corporacion Parc Tauli

OTHER

Sponsor Role lead

Responsible Party

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Esther Via

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ESTHER VIA, PHD

Role: PRINCIPAL_INVESTIGATOR

CORPORACIO SANITARIA PARC TAULI

Locations

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Corporacio Sanitaria Parc Tauli

Sabadell, Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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ESTHER VIA, PHD

Role: CONTACT

0034937240182

Isabel Parra, MD

Role: CONTACT

937 23 10 10 ext. 21761

Facility Contacts

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ESTHER VIA, PHD

Role: primary

0034937240182

Other Identifiers

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CSPT04_TAVA

Identifier Type: -

Identifier Source: org_study_id

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