NCT03625609

Brief 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.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Typical duration for all trials

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 11, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 10, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2020

Completed
Last Updated

August 10, 2018

Status Verified

August 1, 2018

Enrollment Period

1.9 years

First QC Date

August 7, 2018

Last Update Submit

August 9, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Adolescents with ASD. 12-18 years old

You may not qualify if:

  • Non defined

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jordi Torralbas Ortega

Sabadell, Barcelona, 08208, Spain

RECRUITING

MeSH Terms

Conditions

Child Development Disorders, PervasiveSexual Behavior

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental DisordersBehavior

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN

Study Record Dates

First Submitted

August 7, 2018

First Posted

August 10, 2018

Study Start

March 11, 2018

Primary Completion

February 11, 2020

Study Completion

July 11, 2020

Last Updated

August 10, 2018

Record last verified: 2018-08

Locations