Evaluation of a Clinical Transitional Program in Autism

Autism Spectrum Disorder (ASD) Clinical Trial

— TAVA  

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")

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03392870
• Other study ID #: CSPT04_TAVA
• Status: Recruiting
• Phase: N/A
• First received: March 31, 2017
• Last updated: January 2, 2018
• Start date: March 1, 2017
• Est. completion date: April 2019

Study information

• Verified date: January 2018
• Source: Corporacion Parc Tauli
• Contact: ESTHER VIA, PHD
• Phone: 0034937240182
• Email: evia[@]tauli.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: April 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autism Spectrum Disorder (ASD)
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Corporacio Sanitaria Parc Tauli	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Quality of life.	The World Health Organization Quality of Life (WHOQOL). Self-administered scale, quantitative. Spanish version.	Baseline, 24 months
Secondary	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
Secondary	Change in: Depressive symptoms	Beck Depression Inventory-II (BDI-II) . Self-administered scale, quantitative.Spanish version.	Baseline, 24 months
Secondary	Change in: Anxiety Symptoms.	Beck Anxiety Inventory (BAI). Self-administered scale, quantitative.Spanish version.	Baseline, 24 months
Secondary	Change in: Obsessive-compulsive symptoms.	Obsessive-Compulsive Inventory - Revised (OCI-R). Self-administered scale, quantitative. Spanish version.	Baseline, 24 months
Secondary	Change in: ASD symptoms evaluated by parents/caregiver.	Social Responsiveness Scale (SRS). Parents' self-administered scale, quantitative.Spanish version.	Baseline, 24 months
Secondary	Change in: ASD symptoms.	Ritvo Autism Asperger's Diagnostic Scale (RAADS-R). Self-administered scale, quantitative. Spanish- translated version.	Baseline, 24 months
Secondary	Change in: Social phobia symptoms.	Social Phobia Inventory (SPIN). Self-administered scale, quantitative. Spanish version.	Baseline, 24 months
Secondary	Change in: Evaluation of support needs.	Camberwell Assessment of Need, revised (CAN-R). Administered by the professional, qualitative. Spanish version.	Baseline, 24 months
Secondary	Change in: Caregiver's burden associated with the disorder.	The Zarit Burden Interview. Caregiver self-report, quantitative. Spanish version.	Baseline, 24 months
Secondary	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