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Trial record 93 of 185 for:    trisomy21 NOT prenatal

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

Tracking Information
First Submitted Date  ICMJE April 27, 2017
First Posted Date  ICMJE May 1, 2017
Last Update Posted Date June 18, 2018
Actual Study Start Date  ICMJE March 6, 2017
Actual Primary Completion Date September 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2017)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Parents as the Primary Sexuality Educators for Their Young Adults With Down Syndrome
Official Title  ICMJE Parents as the Primary Sexuality Educators for Their Young Adults With Down Syndrome: The Effectiveness of a Family-based Training
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Down Syndrome
  • Intellectual Disability
  • Sexuality
  • Parent-Child Relations
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Parent training
All registered participants will participate in a series of trainings (3 separate) on sexuality education.
Intervention: Behavioral: Parent training
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 14, 2018)
Original Estimated Enrollment  ICMJE
 (submitted: April 27, 2017)
Actual Study Completion Date  ICMJE June 1, 2018
Actual Primary Completion Date September 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03135236
Other Study ID Numbers  ICMJE AdvocateHC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: IPD will not be shared with other researchers.
Responsible Party Katie Frank, PhD, OTR/L, Advocate Health Care
Study Sponsor  ICMJE Advocate Health Care
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Katie Frank, PhD, OTR/L Advocate Healthcare
PRS Account Advocate Health Care
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP