Clinical trial NCT03135236: Parents as the Primary Sexuality Educators for Their Young Adults With Down Syndrome
Official title: Parents as the Primary Sexuality Educators for Their Young Adults With Down Syndrome: The Effectiveness of a Family-based Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Down Syndrome
Intellectual Disability
Sexuality
Parent-Child Relations
Keywords: Parent training
Family education
Young adults
Down syndrome
sexuality
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2017-05-01
Enrollment: 13
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: By integrating sexuality and disability literatures, theories, and research methodologies, this study aims to: 1) contribute to the limited knowledge professionals have of parents as the primary sexuality educators; 2) create a resource for parents in order to be sexuality educators for their young adults with I/DD; and 3) evaluate the effectiveness of the Home B.A.S.E. for Developmental Disabilities Curriculum.

In order to meet the objectives the study seeks to answer the following questions:

1. What is the effectiveness of a sexuality education workshop for parents of young adults with DS on improving the self-efficacy and attitudes around sexuality and healthy relationships for young adults with DS as well as increase the parent-child communication on sexuality topics?
2. What are parents' concerns that impact their ability to be the primary sexuality educators for their young adults with DS? It is proposed that parent confidence and comfort talking about sexuality topics with their young adult with Down syndrome will increase thereby increasing the parent-child communication as a result of this study.

Detailed description: Enrollment will begin and will end once 30 eligible subjects have been identified. Anticipated duration is one year. Participants will enroll in one of the 4 different training series. Each series will have 3 dates they must attend. Once enrolled and consent is documented, eligible subject's will participate in the study for approximately three months. Participants will be expected to attend 3 training sessions over a 4 week period, each are up to 3 hours in length. There will be a follow-up post-survey one month after the last training and an optional phone interview that will occur 2 months after the final training. Participants will be compensated for their time with a $50 gift card once the final post-survey has been received. The gift card will be mailed to the family. Data analysis will begin once all trainings have been completed. Investigators anticipate completing the study, including primary analyses, within two years from the date recruitment begins.

Eligibility criteria: Inclusion Criteria:

* Parents of young adults with Down syndrome ages 20-30.
* Be able to communicate in English

Exclusion Criteria:

* Parents of young adults between the ages of 20 and 30 without Down syndrome
* Parents of individuals with Down syndrome younger than 20 or older than 30.
* Parents unable to attend 3 training sessions.
* Not fluent English communicators.
* Any vulnerable populations including pregnant women, neonates, prisoners, children, cognitively impaired adults, or adults unable to consent

Primary outcomes:
measure: Pre-survey, post-survey, and final post-survey
timeFrame: 15-20 minutes
Secondary outcomes:
measure: Qualitative data
timeFrame: 5-15 minutes
Other outcomes:
Locations:
city: Park Ridge
country: United States
facility: Advocate Adult Down Syndrome Center
state: Illinois
Study officials:
affiliation: Advocate Healthcare
name: Katie Frank, PhD, OTR/L
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bundy, M. L., White, P.N. (1990). Parents as sexuality educators: A parent training program. Journal of Counseling & Development, 68: 321-323.
citation: Frank, K. E. (2016). Parents as the primary sexuality educators for their adolescents with Down syndrome. (Doctoral dissertation). University of Illinois at Chicago, Chicago, IL. Retrieved from Indigo at http://hdl.handle.net/10027/21214.
citation: Klein JD, Sabaratnam P, Pazos B, Auerbach MM, Havens CG, Brach MJ. Evaluation of the parents as primary sexuality educators program. J Adolesc Health. 2005 Sep;37(3 Suppl):S94-9. doi: 10.1016/j.jadohealth.2005.05.004.
citation: Raffaelli M, Bogenschneider K, Flood MF. Parent-teen communication about sexual topics. J Fam Issues. 1998 May;19(3):315-33. doi: 10.1177/019251398019003005.