Evaluation of a Clinical Transitional Program in Autism

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Autism Spectrum Disorder (ASD)

Intervention / Treatment
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* Other: Integrative interventional programme
* Other: As usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAVA-ACTIVE<br>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<br>* 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.<br>|
| Active Comparator: CONTROL<br>As usual | Other: As usual<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autism Spectrum Disorder (ASD), Transition program