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Parents as the Primary Sexuality Educators for Their Young Adults With Down Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03135236
Recruitment Status : Completed
First Posted : May 1, 2017
Last Update Posted : June 18, 2018
Information provided by (Responsible Party):
Katie Frank, PhD, OTR/L, Advocate Health Care

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.

Condition or disease Intervention/treatment Phase
Down Syndrome Intellectual Disability Sexuality Parent-Child Relations Behavioral: Parent training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Parents as the Primary Sexuality Educators for Their Young Adults With Down Syndrome: The Effectiveness of a Family-based Training
Actual Study Start Date : March 6, 2017
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : June 1, 2018

Arm Intervention/treatment
Experimental: Parent training
All registered participants will participate in a series of trainings (3 separate) on sexuality education.
Behavioral: Parent training
Participants will attend 3 trainings. There will be a pre-test before training 1 and an initial post-test after training 3. There will be a final post-test 1 month after the final training.

Primary Outcome Measures :
  1. Pre-survey, post-survey, and final post-survey [ Time Frame: 15-20 minutes ]
    A paper survey will be completed before training 1 that gathers quantitative data that will address attitudes, self-efficacy, and behaviors of the parents in attendance. The survey will also be completed at the end of training 3 and then mailed to the participant to complete 1 month after the final training. The quantitative data will be used to measure a change in the attendees' attitudes, confidence, and behaviors before and after the proposed intervention. Data will be analyzed using SPSS.

Secondary Outcome Measures :
  1. Qualitative data [ Time Frame: 5-15 minutes ]
    Qualitative data will be collected at the end of the first and second training session with two to three take home open-ended questions for each participant to answer as well as after the training is over with open ended questions on the initial follow-up survey. Structured phone interviews will be completed with a small sample of the participants after the one month follow-up paper survey. Answers and interview questions will be transcribed, coded, and themes will be established.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03135236

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United States, Illinois
Advocate Adult Down Syndrome Center
Park Ridge, Illinois, United States, 60068
Sponsors and Collaborators
Advocate Health Care
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Principal Investigator: Katie Frank, PhD, OTR/L Advocate Healthcare

Bundy, M. L., White, P.N. (1990). Parents as sexuality educators: A parent training program. Journal of Counseling & Development, 68: 321-323.
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

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Responsible Party: Katie Frank, PhD, OTR/L, Occupational therapist, Advocate Health Care Identifier: NCT03135236    
Other Study ID Numbers: AdvocateHC
First Posted: May 1, 2017    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Katie Frank, PhD, OTR/L, Advocate Health Care:
Parent training
Family education
Young adults
Down syndrome
Additional relevant MeSH terms:
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Down Syndrome
Intellectual Disability
Pathologic Processes
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders