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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03625609
Other study ID # 2018/509
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 11, 2018
Est. completion date July 11, 2020

Study information

Verified date August 2018
Source Hospital Parc Taulí, Sabadell
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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.

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date July 11, 2020
Est. primary completion date February 11, 2020
Accepts healthy volunteers No
Gender All
Age group 12 Years to 18 Years
Eligibility Inclusion Criteria:

- Adolescents with ASD. 12-18 years old

Exclusion Criteria:

- Non defined

Study Design


Locations

Country Name City State
Spain Jordi Torralbas Ortega Sabadell Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Hospital Parc Taulí, Sabadell

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 12-18 years old
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