Autistic Disorders SpectrumNCT03625609
Sexaffectivity in Autistic Spectrum Disorder
An observational study of Autistic Disorders Spectrum and Sexual Behavior, run by Parc Taulí Hospital Universitari at 1 site in Spain.
Trial summary
The WHO defines sexual health as a state of physical, emotional, mental and social well-being, related to sexuality, not only the absence of illness, dysfunction or disability. To acquire and maintain adequate sexual health, the sexual rights of all people must be respected, protected and fully exercised. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Autistic Disorders Spectrum, Sexual Behavior, Adolescent Development
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 11 Mar 2018to 11 Jul 2020
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Boys and girls with ASD who want to participate in the collection of a scale with their families. Ages between 12 years old and 18 years old.
Who may be able to join
- Adolescents with ASD. 12-18 years old
Who cannot join
- Non defined
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Jordi Torralbas Ortega
Sabadell, Barcelona, 08208
Jordi Torralbas Ortega, MSc, +34-937458221, jorditorralbas@hotmail.com
About this study
Official title: Sexaffectivity in Autistic Spectrum Disorder: Observed Behaviors and Referred Needs in Adolescence
The WHO defines sexual health as a state of physical, emotional, mental and social well-being, related to sexuality, not only the absence of illness, dysfunction or disability. To acquire and maintain adequate sexual health, the sexual rights of all people must be respected, protected and fully exercised.
People with Autism Spectrum Disorder (ASD) present difficulties in the development of social interaction skills, among other problems that directly affect their sexual health. The consolidated prejudices and social myths related to the sexual affectivity of people with ASD, and in general to people with intellectual diversity, have meant that they do not pay any attention to the sexual health of this group in the assessment of their needs.
Read more
Main objectives: to understand the experience lived by young people with ASD and their caregivers in relation to the affective needs during adolescence and to know the cognitive and behavioral expression of the affective dimension of adolescents with ASD.
Mixed simultaneous design: qualitative based on the phenomenological paradigm, in order to establish the perceived needs of young adults with ASD, their families and the professionals who attend them, with the realization of focus groups and in-depth interviews. The second quantitative part will be developed in adolescents (12-18 years) and their families, evaluating the habitual behaviors and difficulties of Interaction in the affective expression, by means of questionnaires and self-administered scales. It will be necessary to sign the Informed Consent by all the participants, with the specific acceptance of the project by the CEIC of the investigator's center.
- Medical subject headings
- Child Development Disorders, Pervasive, Sexual Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual Behaivor Scale
The measure utilized was developed specifically for this research - the Sexual Behaviour Scale (SBS; see Appendix) - and was based upon previous studies and the issues these studies identified (cf. Haracopos and Pedersen, 1992; Ruble and Dalrymple, 1993). The SBS examined parents' reports of their child's: (1) social behaviour; (2) privacy awareness; (3) sex education; and (4) sexual behaviour; as well as (5) parental concerns about outcomes for their child.
Measured: 12-18 years old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start11 Mar 2018
- Primary completion11 Feb 2020 (estimated)
- Study completion11 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autistic Disorders SpectrumStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Parc Taulí Hospital Universitari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jordi Torralbas Ortega, Parc Taulí Hospital Universitari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03625609
- Sponsor's protocol ID
- 2018/509
- Status last verified
- Aug 2018
- First submitted
- 7 Aug 2018
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexaffectivity in Autistic Spectrum Disorder: Observed Behaviors and Referred Needs in Adolescence
- ClinicalTrials.gov ID
- NCT03625609
- Acronym / sponsor ID
- 2018/509
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Parc Taulí Hospital UniversitariUniversity, hospital or other
- Study start
- 11 Mar 2018 (actual)
- Primary completion
- 11 Feb 2020 (estimated)
- Study completion
- 11 Jul 2020 (estimated)
- First posted
- 10 Aug 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.
The WHO defines sexual health as a state of physical, emotional, mental and social well-being, related to sexuality, not only the absence of illness, dysfunction or disability. To acquire and maintain adequate sexual health, the sexual rights of all people must be respected, protected and fully exercised.
People with Autism Spectrum Disorder (ASD) present difficulties in the development of social interaction skills, among other problems that directly affect their sexual health. The consolidated prejudices and social myths related to the sexual affectivity of people with ASD, and in general to people with intellectual diversity, have meant that they do not pay any attention to the sexual health of this group in the assessment of their needs.
Main objectives: to understand the experience lived by young people with ASD and their caregivers in relation to the affective needs during adolescence and to know the cognitive and behavioral expression of the affective dimension of adolescents with ASD.
Mixed simultaneous design: qualitative based on the phenomenological paradigm, in order to establish the perceived needs of young adults with ASD, their families and the professionals who attend them, with the realization of focus groups and in-depth interviews. The second quantitative part will be developed in adolescents (12-18 years) and their families, evaluating the habitual behaviors and difficulties of Interaction in the affective expression, by means of questionnaires and self-administered scales. It will be necessary to sign the Informed Consent by all the participants, with the specific acceptance of the project by the CEIC of the investigator's center.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Boys and girls with ASD who want to participate in the collection of a scale with their families. Ages between 12 years old and 18 years old.
Key inclusion criteria (1 listed)
- Adolescents with ASD. 12-18 years old
Key exclusion criteria (1 listed)
- Non defined
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sexual Behaivor Scale
Time frame: 12-18 years old
The measure utilized was developed specifically for this research - the Sexual Behaviour Scale (SBS; see Appendix) - and was based upon previous studies and the issues these studies identified (cf. Haracopos and Pedersen, 1992; Ruble and Dalrymple, 1993). The SBS examined parents' reports of their child's: (1) social behaviour; (2) privacy awareness; (3) sex education; and (4) sexual behaviour; as well as (5) parental concerns about outcomes for their child.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autistic Disorders Spectrum and Sexual Behavior, run by Parc Taulí Hospital Universitari 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 1 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 10 Aug 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual Behaivor Scale (time frame: 12-18 years old). 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 10 Aug 2018.