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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| CONTROL | Active Comparator | As usual |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integrative interventional programme | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
- Living in a disabled residential setting
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ESTHER VIA, PHD | Contact | 0034937240182 | evia@tauli.cat | |
| Isabel Parra, MD | Contact | 937 23 10 10 | 21761 | iparra@tauli.cat |
| Name | Affiliation | Role |
|---|---|---|
| ESTHER VIA, PHD | CORPORACIO SANITARIA PARC TAULI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Corporacio Sanitaria Parc Tauli | Recruiting | Sabadell | Barcelona | 08208 | Spain |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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A researcher will be masked for group aleatorization (active, group) in order to unbiasedly evaluate outcomes which require subjective assesment of functionality.
| As usual | Other | 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. |
|
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 |