NCT03392870

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 31, 2017

Completed
9 months until next milestone

First Posted

Study publicly available on registry

January 8, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

January 8, 2018

Status Verified

January 1, 2018

Enrollment Period

2 years

First QC Date

March 31, 2017

Last Update Submit

January 2, 2018

Conditions

Autism Spectrum Disorder (ASD)

Keywords

Autism Spectrum Disorder (ASD)Transition program

Outcome Measures

Primary Outcomes (1)

  • Change in Quality of life.

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

    Baseline, 24 months

Secondary Outcomes (10)

  • Change in: Asperger Symptoms.

    Baseline, 24 months

  • Change in: Depressive symptoms

    Baseline, 24 months

  • Change in: Anxiety Symptoms.

    Baseline, 24 months

  • Change in: Obsessive-compulsive symptoms.

    Baseline, 24 months

  • Change in: ASD symptoms evaluated by parents/caregiver.

    Baseline, 24 months

  • +5 more secondary outcomes

Study Arms (2)

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.

Other: Integrative interventional programme

CONTROL

ACTIVE COMPARATOR

As usual

Other: As usual

Interventions

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.

TAVA-ACTIVE
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.

CONTROL

Eligibility Criteria

Age18 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASD diagnosis
  • Previous follow-up by child and adolescent psychiatry department at Corporació Sanitària Parc Taulí (CSPT)

You may not qualify if:

  • \- Living in a disabled residential setting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Corporacio Sanitaria Parc Tauli

Sabadell, Barcelona, 08208, Spain

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • ESTHER VIA, PHD

    CORPORACIO SANITARIA PARC TAULI

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ESTHER VIA, PHD

CONTACT

0034937240182evia@tauli.cat

Isabel Parra, MD

CONTACT

937 23 10 10iparra@tauli.cat

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
A researcher will be masked for group aleatorization (active, group) in order to unbiasedly evaluate outcomes which require subjective assesment of functionality.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 31, 2017

First Posted

January 8, 2018

Study Start

March 1, 2017

Primary Completion

March 1, 2019

Study Completion

April 1, 2019

Last Updated

January 8, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)