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Evaluation of a Clinical Transitional Program in Autism (TAVA)

Primary Purpose

Autism Spectrum Disorder (ASD)

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Integrative interventional programme
As usual
Sponsored by
Corporacion Parc Tauli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder (ASD) focused on measuring Autism Spectrum Disorder (ASD), Transition program

Eligibility Criteria

18 Years - 21 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Corporacio Sanitaria Parc TauliRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TAVA-ACTIVE

CONTROL

Arm Description

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.

As usual

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 31, 2017
Last Updated
January 2, 2018
Sponsor
Corporacion Parc Tauli
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1. Study Identification

Unique Protocol Identification Number
NCT03392870
Brief Title
Evaluation of a Clinical Transitional Program in Autism
Acronym
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")
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
April 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Corporacion Parc Tauli

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder (ASD)
Keywords
Autism Spectrum Disorder (ASD), Transition program

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAVA-ACTIVE
Arm Type
Experimental
Arm Description
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.
Arm Title
CONTROL
Arm Type
Active Comparator
Arm Description
As usual
Intervention Type
Other
Intervention Name(s)
Integrative interventional programme
Intervention Description
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
Intervention Name(s)
As usual
Intervention Description
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 Measure Information:
Title
Change in Quality of life.
Description
The World Health Organization Quality of Life (WHOQOL). Self-administered scale, quantitative. Spanish version.
Time Frame
Baseline, 24 months
Secondary Outcome Measure Information:
Title
Change in: Asperger Symptoms.
Description
Adult Asperger Assessment (AAA). Includes questionnaire (autism spectrum quotient, AQ) and (empathy quotient, EQ). Self-administered scale, quantitative.Spanish version.
Time Frame
Baseline, 24 months
Title
Change in: Depressive symptoms
Description
Beck Depression Inventory-II (BDI-II) . Self-administered scale, quantitative.Spanish version.
Time Frame
Baseline, 24 months
Title
Change in: Anxiety Symptoms.
Description
Beck Anxiety Inventory (BAI). Self-administered scale, quantitative.Spanish version.
Time Frame
Baseline, 24 months
Title
Change in: Obsessive-compulsive symptoms.
Description
Obsessive-Compulsive Inventory - Revised (OCI-R). Self-administered scale, quantitative. Spanish version.
Time Frame
Baseline, 24 months
Title
Change in: ASD symptoms evaluated by parents/caregiver.
Description
Social Responsiveness Scale (SRS). Parents' self-administered scale, quantitative.Spanish version.
Time Frame
Baseline, 24 months
Title
Change in: ASD symptoms.
Description
Ritvo Autism Asperger's Diagnostic Scale (RAADS-R). Self-administered scale, quantitative. Spanish- translated version.
Time Frame
Baseline, 24 months
Title
Change in: Social phobia symptoms.
Description
Social Phobia Inventory (SPIN). Self-administered scale, quantitative. Spanish version.
Time Frame
Baseline, 24 months
Title
Change in: Evaluation of support needs.
Description
Camberwell Assessment of Need, revised (CAN-R). Administered by the professional, qualitative. Spanish version.
Time Frame
Baseline, 24 months
Title
Change in: Caregiver's burden associated with the disorder.
Description
The Zarit Burden Interview. Caregiver self-report, quantitative. Spanish version.
Time Frame
Baseline, 24 months
Title
Change in: Evaluation of the level of autonomy, self-regulation, self-empowerment, self-knowledge.
Description
The Arc's Self-Determination Scale. Self-administered scale. Spanish version. Quantitative.
Time Frame
Baseline, 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ESTHER VIA, PHD
Phone
0034937240182
Email
evia@tauli.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Isabel Parra, MD
Phone
937 23 10 10
Ext
21761
Email
iparra@tauli.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ESTHER VIA, PHD
Organizational Affiliation
CORPORACIO SANITARIA PARC TAULI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Corporacio Sanitaria Parc Tauli
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ESTHER VIA, PHD
Phone
0034937240182
Email
evia.tauli@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of a Clinical Transitional Program in Autism

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