Autism Spectrum Disorder (ASD)TAVANCT03392870
Evaluation of a Clinical Transitional Program in Autism
A study testing Integrative interventional programme and As usual in people with Autism Spectrum Disorder (ASD), run by Corporacion Parc Tauli at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 21 years
- Conditions the study is for
- Autism Spectrum Disorder (ASD)
- What is being tested?
- Integrative interventional programme and As usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2017to Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 21 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASD diagnosis
- Previous follow-up by child and adolescent psychiatry department at Corporació Sanitària Parc Taulí (CSPT)
Who cannot join
- Living in a disabled residential setting
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, 08208
ESTHER VIA, PHD, 0034937240182, evia.tauli@gmail.com
About this study
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 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.
- Conditions
- Autism Spectrum Disorder (ASD)
- Being tested
- Integrative interventional programme, As usual
- Keywords
- Autism Spectrum Disorder (ASD), Transition program
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrative interventional programmeOther
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 usualOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Integrative interventional programme |
| CONTROL | Active comparator | As usual Receives: Other: As usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of life.
The World Health Organization Quality of Life (WHOQOL). Self-administered scale, quantitative. Spanish version.
Measured: Baseline, 24 months
Secondary outcomes (10)
Change in: Asperger Symptoms.
Adult Asperger Assessment (AAA). Includes questionnaire (autism spectrum quotient, AQ) and (empathy quotient, EQ). Self-administered scale, quantitative.Spanish version.
Measured: Baseline, 24 months
Change in: Depressive symptoms
Beck Depression Inventory-II (BDI-II) . Self-administered scale, quantitative.Spanish version.
Measured: Baseline, 24 months
Change in: Anxiety Symptoms.
Beck Anxiety Inventory (BAI). Self-administered scale, quantitative.Spanish version.
Measured: Baseline, 24 months
Change in: Obsessive-compulsive symptoms.
Obsessive-Compulsive Inventory - Revised (OCI-R). Self-administered scale, quantitative. Spanish version.
Measured: Baseline, 24 months
Change in: ASD symptoms evaluated by parents/caregiver.
Social Responsiveness Scale (SRS). Parents' self-administered scale, quantitative.Spanish version.
Measured: Baseline, 24 months
Change in: ASD symptoms.
Ritvo Autism Asperger's Diagnostic Scale (RAADS-R). Self-administered scale, quantitative. Spanish- translated version.
Measured: Baseline, 24 months
Change in: Social phobia symptoms.
Social Phobia Inventory (SPIN). Self-administered scale, quantitative. Spanish version.
Measured: Baseline, 24 months
Change in: Evaluation of support needs.
Camberwell Assessment of Need, revised (CAN-R). Administered by the professional, qualitative. Spanish version.
Measured: Baseline, 24 months
Change in: Caregiver's burden associated with the disorder.
The Zarit Burden Interview. Caregiver self-report, quantitative. Spanish version.
Measured: 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.
Measured: Baseline, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start1 Mar 2017
- Primary completionMar 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum Disorder (ASD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esther Via, Corporacion Parc Tauli
- Investigators
- ESTHER VIA, PHD, Principal investigator, CORPORACIO SANITARIA PARC TAULI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03392870
- Sponsor's protocol ID
- CSPT04_TAVA
- Acronym
- TAVA
- Status last verified
- Jan 2018
- First submitted
- 31 Mar 2017
- Last updated
- 8 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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")
- ClinicalTrials.gov ID
- NCT03392870
- Acronym / sponsor ID
- TAVA / CSPT04_TAVA
- Conditions
- Autism Spectrum Disorder (ASD)
- Keywords
- Autism Spectrum Disorder (ASD), Transition program
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 8 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAVA-ACTIVE | Experimental | Other: Integrative interventional programmeIntegrative 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. |
| CONTROL | Active comparator | Other: As usualAs usual |
Who may qualify
- Ages
- 18 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ASD diagnosis
- Previous follow-up by child and adolescent psychiatry department at Corporació Sanitària Parc Taulí (CSPT)
Key exclusion criteria (1 listed)
- Living in a disabled residential setting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrative interventional programmeThe 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. | Other | TAVA-ACTIVE |
| As usualThe 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. | Other | CONTROL |
Primary outcome
Change in Quality of life.
Time frame: Baseline, 24 months
The World Health Organization Quality of Life (WHOQOL). Self-administered scale, quantitative. Spanish version.
10 secondary outcomes
Change in: Asperger Symptoms.
Time frame: Baseline, 24 months
Change in: Depressive symptoms
Time frame: Baseline, 24 months
Change in: Anxiety Symptoms.
Time frame: Baseline, 24 months
Change in: Obsessive-compulsive symptoms.
Time frame: Baseline, 24 months
Change in: ASD symptoms evaluated by parents/caregiver.
Time frame: Baseline, 24 months
Change in: ASD symptoms.
Time frame: Baseline, 24 months
Change in: Social phobia symptoms.
Time frame: Baseline, 24 months
Change in: Evaluation of support needs.
Time frame: Baseline, 24 months
Change in: Caregiver's burden associated with the disorder.
Time frame: Baseline, 24 months
Change in: Evaluation of the level of autonomy, self-regulation, self-empowerment, self-knowledge.
Time frame: Baseline, 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2018.
- Individual participant dataSharing planned: No
Related trials for Autism Spectrum Disorder (ASD)
Not yet recruiting
Single Session Support for Parents of Children With Neurodevelopmental Disabilities Struggling With Anxious Avoidance
Neurodevelopmental Disorders, Autism Spectrum Disorder (ASD)
Not yet recruiting
Evaluation of a Novel Quantum-Inspired Intervention (QII) for Children With Autism Spectrum Disorder: A Global Confirmatory Study
Autism Spectrum Disorder, Autism Spectrum Disorder (ASD
Not yet recruitingObservational study
EEG As a Genetic Selection Lever in Autism Spectrum Disorder
Autism Spectrum Disorder (ASD
Recruiting
Coaching and Leadership in Autism Support Settings
Autism Spectrum Disorder (ASD)
Recruiting
External Trigeminal Nerve Stimulation for Children With ASD + ADHD to Reduce Elevated Symptoms
Attention Deficit Disorder With Hyperactivity (ADHD), Autism Spectrum Disorder (ASD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ESTHER VIA, PHD principal investigator
CORPORACIO SANITARIA PARC TAULI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrative interventional programme and As usual in people with Autism Spectrum Disorder (ASD), run by Corporacion Parc Tauli at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ESTHER VIA, PHD (0034937240182, evia@tauli.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of life. (time frame: Baseline, 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2018; AzTrials last refreshed its copy on 30 Oct 2026.