Down SyndromeNCT03135236
Parents as the Primary Sexuality Educators for Their Young Adults With Down Syndrome
A study testing Parent training in people with Down Syndrome and Intellectual Disability, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Down Syndrome, Intellectual Disability, Sexuality
- What is being tested?
- Parent training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2017to 1 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parents of young adults with Down syndrome ages 20-30.
- Be able to communicate in English
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Advocate Adult Down Syndrome Center
Park Ridge, Illinois, 60068
About this study
Official title: Parents as the Primary Sexuality Educators for Their Young Adults With Down Syndrome: The Effectiveness of a Family-based Training
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:
- 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?
- 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.
Read the 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.
- Being tested
- Parent training
- Keywords
- Parent training, Family education, Young adults, Down syndrome, sexuality
- Medical subject headings
- Down Syndrome, Intellectual Disability, Sexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent trainingBehavioural
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 group | Role | What they receive |
|---|---|---|
| Parent training | Experimental | All registered participants will participate in a series of trainings (3 separate) on sexuality education. Receives: Behavioral: Parent training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-survey, post-survey, and final post-survey
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.
Measured: 15-20 minutes
Secondary outcomes (1)
Qualitative data
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.
Measured: 5-15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start6 Mar 2017
- Primary completion30 Sep 2017
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katie Frank, PhD, OTR/L, Principal investigator, Advocate Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03135236
- Sponsor's protocol ID
- AdvocateHC
- Status last verified
- Jun 2018
- First submitted
- 27 Apr 2017
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers.
Publications
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 http://hdl.handle.net/10027/21214.
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.
PubMed 16115575Raffaelli M, Bogenschneider K, Flood MF. Parent-teen communication about sexual topics. J Fam Issues. 1998 May;19(3):315-33. doi: 10.1177/019251398019003005.
PubMed 12295941
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parents as the Primary Sexuality Educators for Their Young Adults With Down Syndrome: The Effectiveness of a Family-based Training
- ClinicalTrials.gov ID
- NCT03135236
- Acronym / sponsor ID
- AdvocateHC
- Keywords
- Parent training, Family education, Young adults, Down syndrome, sexuality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 1 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parent training | Experimental | Behavioral: Parent trainingAll registered participants will participate in a series of trainings (3 separate) on sexuality education. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Parents of young adults with Down syndrome ages 20-30.
- Be able to communicate in English
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent trainingParticipants 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. | Behavioural | Parent training |
Primary outcome
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.
1 secondary outcome
Qualitative data
Time frame: 5-15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- BackgroundBundy, M. L., White, P.N. (1990). Parents as sexuality educators: A parent training program. Journal of Counseling & Development, 68: 321-323.
- BackgroundFrank, 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.
- Background: PubMed 16115575Klein 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.
- Background: PubMed 12295941Raffaelli M, Bogenschneider K, Flood MF. Parent-teen communication about sexual topics. J Fam Issues. 1998 May;19(3):315-33. doi: 10.1177/019251398019003005.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katie Frank, PhD, OTR/L principal investigator
Advocate Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent training in people with Down Syndrome and Intellectual Disability, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-survey, post-survey, and final post-survey (time frame: 15-20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03135236, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.