Evaluation of a Clinical Transitional Program in Autism (TAVA)

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")

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 Overview

• Status: Unknown
• Conditions: Autism Spectrum Disorder (ASD)
• Intervention / Treatment: Other: Integrative interventional programme; Other: As usual

• Study Type: Interventional
• Enrollment (Anticipated): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Recruiting
      • Corporacio Sanitaria Parc Tauli
      • Contact: ESTHER VIA, PHD; Phone Number: 0034937240182; Email: evia.tauli@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 21 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of life.	The World Health Organization Quality of Life (WHOQOL). Self-administered scale, quantitative. Spanish version.	Baseline, 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in: Asperger Symptoms.	Adult Asperger Assessment (AAA). Includes questionnaire (autism spectrum quotient, AQ) and (empathy quotient, EQ). Self-administered scale, quantitative.Spanish version.	Baseline, 24 months
Change in: Depressive symptoms	Beck Depression Inventory-II (BDI-II) . Self-administered scale, quantitative.Spanish version.	Baseline, 24 months
Change in: Anxiety Symptoms.	Beck Anxiety Inventory (BAI). Self-administered scale, quantitative.Spanish version.	Baseline, 24 months
Change in: Obsessive-compulsive symptoms.	Obsessive-Compulsive Inventory - Revised (OCI-R). Self-administered scale, quantitative. Spanish version.	Baseline, 24 months
Change in: ASD symptoms evaluated by parents/caregiver.	Social Responsiveness Scale (SRS). Parents' self-administered scale, quantitative.Spanish version.	Baseline, 24 months
Change in: ASD symptoms.	Ritvo Autism Asperger's Diagnostic Scale (RAADS-R). Self-administered scale, quantitative. Spanish- translated version.	Baseline, 24 months
Change in: Social phobia symptoms.	Social Phobia Inventory (SPIN). Self-administered scale, quantitative. Spanish version.	Baseline, 24 months
Change in: Evaluation of support needs.	Camberwell Assessment of Need, revised (CAN-R). Administered by the professional, qualitative. Spanish version.	Baseline, 24 months
Change in: Caregiver's burden associated with the disorder.	The Zarit Burden Interview. Caregiver self-report, quantitative. Spanish version.	Baseline, 24 months
Change in: Evaluation of the level of autonomy, self-regulation, self-empowerment, self-knowledge.	The Arc's Self-Determination Scale. Self-administered scale. Spanish version. Quantitative.	Baseline, 24 months

Collaborators and Investigators

• Sponsor: Corporacion Parc Tauli
• Investigators: Principal Investigator: ESTHER VIA, PHD, Corporacio Sanitaria Parc Tauli

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: March 31, 2017
• First Submitted That Met QC Criteria: January 2, 2018
• First Posted (Actual): January 8, 2018

Study Record Updates

• Last Update Posted (Actual): January 8, 2018
• Last Update Submitted That Met QC Criteria: January 2, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Autism Spectrum Disorder (ASD); Transition program
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
• Other Study ID Numbers: CSPT04_TAVA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No