Evaluation of a Clinical Transitional Program in Autism (TAVA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03392870
Recruitment Status : Recruiting
First Posted : January 8, 2018
Last Update Posted : January 8, 2018
Information provided by (Responsible Party):
Esther Via, Corporacion Parc Tauli

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder (ASD) Other: Integrative interventional programme Other: As usual Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Primary Purpose: Treatment
Official Title: 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")
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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.
Other: 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.

Active Comparator: CONTROL
As usual
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.

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change in: Asperger Symptoms. [ Time Frame: Baseline, 24 months ]
    Adult Asperger Assessment (AAA). Includes questionnaire (autism spectrum quotient, AQ) and (empathy quotient, EQ). Self-administered scale, quantitative.Spanish version.

  2. Change in: Depressive symptoms [ Time Frame: Baseline, 24 months ]
    Beck Depression Inventory-II (BDI-II) . Self-administered scale, quantitative.Spanish version.

  3. Change in: Anxiety Symptoms. [ Time Frame: Baseline, 24 months ]
    Beck Anxiety Inventory (BAI). Self-administered scale, quantitative.Spanish version.

  4. Change in: Obsessive-compulsive symptoms. [ Time Frame: Baseline, 24 months ]
    Obsessive-Compulsive Inventory - Revised (OCI-R). Self-administered scale, quantitative. Spanish version.

  5. Change in: ASD symptoms evaluated by parents/caregiver. [ Time Frame: Baseline, 24 months ]
    Social Responsiveness Scale (SRS). Parents' self-administered scale, quantitative.Spanish version.

  6. Change in: ASD symptoms. [ Time Frame: Baseline, 24 months ]
    Ritvo Autism Asperger's Diagnostic Scale (RAADS-R). Self-administered scale, quantitative. Spanish- translated version.

  7. Change in: Social phobia symptoms. [ Time Frame: Baseline, 24 months ]
    Social Phobia Inventory (SPIN). Self-administered scale, quantitative. Spanish version.

  8. Change in: Evaluation of support needs. [ Time Frame: Baseline, 24 months ]
    Camberwell Assessment of Need, revised (CAN-R). Administered by the professional, qualitative. Spanish version.

  9. Change in: Caregiver's burden associated with the disorder. [ Time Frame: Baseline, 24 months ]
    The Zarit Burden Interview. Caregiver self-report, quantitative. Spanish version.

  10. Change in: Evaluation of the level of autonomy, self-regulation, self-empowerment, self-knowledge. [ Time Frame: Baseline, 24 months ]
    The Arc's Self-Determination Scale. Self-administered scale. Spanish version. Quantitative.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 21 Years   (Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03392870

Contact: ESTHER VIA, PHD 0034937240182
Contact: Isabel Parra, MD 937 23 10 10 ext 21761

Corporacio Sanitaria Parc Tauli Recruiting
Sabadell, Barcelona, Spain, 08208
Contact: ESTHER VIA, PHD    0034937240182   
Sponsors and Collaborators
Corporacion Parc Tauli

Responsible Party: Esther Via, Principal Investigator, Corporacion Parc Tauli Identifier: NCT03392870     History of Changes
Other Study ID Numbers: CSPT04_TAVA
First Posted: January 8, 2018    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Esther Via, Corporacion Parc Tauli:
Autism Spectrum Disorder (ASD)
Transition program

Additional relevant MeSH terms:
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders