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Clinical Trials/NCT03392870
NCT03392870UnknownNot Applicable

Evaluation of a Clinical Program Specialized in the Diagnosis, Follow-up and Treatment of Young Adults With a Autism Spectrum Disorder: "TAVA" (Spanish Acronym for "Support to Subjects With Autism in Their Transition to Adulthood")

Corporacion Parc Tauli1 site in 1 country102 target enrollmentStarted: March 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
102
Locations
1
Primary Endpoint
Change in Quality of life.

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

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

Eligibility Criteria

Ages
18 Years to 21 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

TAVA-ACTIVE

Experimental

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.

Intervention: Integrative interventional programme (Other)

CONTROL

Active Comparator

As usual

Intervention: As usual (Other)

Outcomes

Primary Outcomes

Change in Quality of life.

Time Frame: Baseline, 24 months

The World Health Organization Quality of Life (WHOQOL). Self-administered scale, quantitative. Spanish version.

Secondary Outcomes

  • Change in: ASD symptoms evaluated by parents/caregiver.(Baseline, 24 months)
  • Change in: ASD symptoms.(Baseline, 24 months)
  • Change in: Depressive symptoms(Baseline, 24 months)
  • Change in: Caregiver's burden associated with the disorder.(Baseline, 24 months)
  • Change in: Asperger Symptoms.(Baseline, 24 months)
  • Change in: Evaluation of support needs.(Baseline, 24 months)
  • Change in: Evaluation of the level of autonomy, self-regulation, self-empowerment, self-knowledge.(Baseline, 24 months)
  • Change in: Anxiety Symptoms.(Baseline, 24 months)
  • Change in: Social phobia symptoms.(Baseline, 24 months)
  • Change in: Obsessive-compulsive symptoms.(Baseline, 24 months)

Investigators

Sponsor
Corporacion Parc Tauli
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Esther Via

Principal Investigator

Corporacion Parc Tauli

Study Sites (1)

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