Sexually Transmitted InfectionsNCT01144871
Parental Knowledge and Attitudes of Confidential Sexually Transmitted Infections (STI) Services for Teens
An observational study of Sexually Transmitted Infections, run by University of California, San Francisco at 3 sites in United States.
Trial summary
This study will provide new and important information regarding parental knowledge and attitudes of confidential STI and related health care services (prevention, diagnosis and treatment) for teens that may be needed to address the STI epidemic. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sexually Transmitted Infections
- How many people
- 1,216 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2007to Aug 2011
- Phase
- Observational
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Parents/Guardians who have adolescents between 12-17 years of age
Who may be able to join
- Parents/Guardians who have adolescents between 12-17 years of age
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mission Neighborhood Health Center
San Francisco, California, 94110
San Francisco General Hospital
San Francisco, California, 94110
Kaiser Permanente Northern California
San Francisco, California, 94115
About this study
Official title: Parental Knowledge and Attitudes of Confidential STI Services for Teens
This study will provide new and important information regarding parental knowledge and attitudes of confidential STI and related health care services (prevention, diagnosis and treatment) for teens that may be needed to address the STI epidemic. Using both qualitative and quantitative methods, this study will gather information necessary to develop effective interventions aimed at the often neglected parent component of the teen-parent-health care provider partnership by giving parents knowledge and skills to help them facilitate their adolescent's access to confidential STI services as needed.
Read the detailed description
Teens' access to confidential services for sexually transmitted infections (STI's) has been assured over time by privacy protections established through statutory and policy routes. Yet, the STI epidemic among youth persists, in part , because many STI's are largely asymptomatic, remain undetected and continue to be transmitted unknowingly. Also, many teens are reluctant to obtain STI services due to embarrassment, fear of disclosure, lack of knowledge about STI diagnosis/treatment, and confidential STI services. How do we bridge the gap between availability and apparent lack of utilization by teens in need of confidential services to prevent STI's and their long term sequelae? One strategy that has been overlooked is the engagement of parents in a partnership with the teen and the provider to effectively guide the developing adolescent towards becoming a responsible and confident adult consumer of health services, especially regarding STI prevention and care including confidential services. Before developing the parental component to a broad-based effort aimed at decreasing the STI rate, especially C. trachomatis, it is important to examine parental knowledge and attitudes towards confidential STI health services for teens and how these might influence parental intention to facilitate their adolescent's accessing appropriate preventive care for STIs. We propose a multi-method research design in 2 phases. Phase 1 comprises a qualitative format (focus groups and 1:1 semi-structured interviews) designed to yield data on parental knowledge and attitudes about confidential STI related health care services for teens. Findings from Phase 1 will then inform Phase 2, a quantitative cross-sectional survey of a random sample of ethnically diverse parents of 12-17 yo teens designed to examine the following questions. First, how does parental knowledge and attitudes about STI confidential care for teens vary according: (a) the adolescent's age and gender; and (b) the specific parental characteristics, e.g., gender, race/ethnicity, insurance status, education, religiosity. Secondly, how does parental knowledge and attitudes about confidential care for teens affect parental behavioral intentions to facilitate their teen's gaining knowledge and skills to be able to access STI preventive confidential services. This research would inform investigations how to strengthen the role of parents and encourage partnerships between health care providers and parents to ultimately improve the health outcomes for teens.
Hypotheses:
- Parental knowledge of confidential care for adolescents will increase parental intention to facilitate confidential care
- Parental knowledge of STI's will be positively associated with their perceptions of their teen's susceptibility to/ severity of STI
- Parental knowledge or suspicion that their adolescent is having sex will be associated with perceptions that their teen is susceptibility to STIs
- Parental knowledge of STI's and/or knowledge/ suspicion adolescent is having sex will be associated with parental intention to facilitate confidential care
- Perceived susceptibility/severity of their teen to STI will be associated with a greater intention to facilitate confidential care
- Perceived benefits of confidential care will be associated with an greater intention to facilitate confidential care
- Perceived risks/barriers to confidential care (e.g., logistical/billing; busy practice, no policy/time for provider to see teen alone; perceived increase risky teen behavior due to such sexual health discussions) will be negatively associated with intention to facilitate confidential care
- Perceived self-efficacy will be associated with an greater intention to facilitate confidential care
- Past behavior/experiences regarding confidential care for parent and/or adolescent will be associated with intention to facilitate confidential care
Specific Aims:
- To examine parental knowledge and attitudes of confidential health services related to STI care for adolescents
- To examine how parental knowledge and attitudes of confidentiality regarding STI and related health care services vary according to parent characteristics
- To examine how parental knowledge and attitudes of confidentiality regarding STI and related health care services vary according to child characteristics ii. To examine how parental knowledge and attitudes toward confidential STI care affects the parent's behavioral intentions to support their adolescent's access to confidential care iii. To identify key mechanisms that will form the basis of an intervention to improve parent-health care provider partnerships by giving parents knowledge and skills to help them facilitate their adolescent's access to confidential STI services as needed
- Conditions
- Sexually Transmitted Infections
- Keywords
- adolescent, reproductive health, parents, STIs, confidentiality, Examine parental knowledge/attitudes of confidential health services/STI care for adolescents., Examine how parental knowledge/attitudes affects parent's behavioral intentions to support adolescent's access to confidential care., Identify key mechanisms to form an intervention to parents knowledge/skills to facilitate teen's access to confidential STI services.
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Male Parent/Guardians | Male Parent/Guardian of Adolescent 12-17 yo. Health care members of either San Francisco General Hospital or Kaiser Permanente Northern California. | |
| Female Parent/Guardian | Female Parent/Guardian of Adolescent 12-17 yo. Health care members of either San Francisco General Hospital or Kaiser Permanente Northern California. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determining parental attitudes regarding confidential health services for their teens
Parental attitudes and knowledge regarding confidential health services will be assessed with focus groups, interviews and phone surveying.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2010 (estimated)
- Study startSep 2007
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexually Transmitted InfectionsStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,216 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Kaiser Permanente
- Responsible party
- Sponsor
- Investigators
- Mary-Ann Shafer, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01144871
- Sponsor's protocol ID
- H1095-31348
- Other IDs
- R01HD053408-01A2
- Status last verified
- Oct 2014
- First submitted
- 14 Jun 2010
- Last updated
- 28 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parental Knowledge and Attitudes of Confidential STI Services for Teens
- ClinicalTrials.gov ID
- NCT01144871
- Acronym / sponsor ID
- H1095-31348
- Conditions
- Sexually Transmitted Infections
- Keywords
- adolescent, reproductive health, parents, STIs, confidentiality, Examine parental knowledge/attitudes of confidential health services/STI care for adolescents., Examine how parental knowledge/attitudes affects parent's behavioral intentions to support adolescent's access to confidential care., Identify key mechanisms to form an intervention to parents knowledge/skills to facilitate teen's access to confidential STI services.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,216 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Kaiser Permanente
- Study start
- Sep 2007
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 16 Jun 2010 (estimated)
- 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.
This study will provide new and important information regarding parental knowledge and attitudes of confidential STI and related health care services (prevention, diagnosis and treatment) for teens that may be needed to address the STI epidemic. Using both qualitative and quantitative methods, this study will gather information necessary to develop effective interventions aimed at the often neglected parent component of the teen-parent-health care provider partnership by giving parents knowledge and skills to help them facilitate their adolescent's access to confidential STI services as needed.
Detailed description
Teens' access to confidential services for sexually transmitted infections (STI's) has been assured over time by privacy protections established through statutory and policy routes. Yet, the STI epidemic among youth persists, in part , because many STI's are largely asymptomatic, remain undetected and continue to be transmitted unknowingly. Also, many teens are reluctant to obtain STI services due to embarrassment, fear of disclosure, lack of knowledge about STI diagnosis/treatment, and confidential STI services. How do we bridge the gap between availability and apparent lack of utilization by teens in need of confidential services to prevent STI's and their long term sequelae? One strategy that has been overlooked is the engagement of parents in a partnership with the teen and the provider to effectively guide the developing adolescent towards becoming a responsible and confident adult consumer of health services, especially regarding STI prevention and care including confidential services. Before developing the parental component to a broad-based effort aimed at decreasing the STI rate, especially C. trachomatis, it is important to examine parental knowledge and attitudes towards confidential STI health services for teens and how these might influence parental intention to facilitate their adolescent's accessing appropriate preventive care for STIs. We propose a multi-method research design in 2 phases. Phase 1 comprises a qualitative format (focus groups and 1:1 semi-structured interviews) designed to yield data on parental knowledge and attitudes about confidential STI related health care services for teens. Findings from Phase 1 will then inform Phase 2, a quantitative cross-sectional survey of a random sample of ethnically diverse parents of 12-17 yo teens designed to examine the following questions. First, how does parental knowledge and attitudes about STI confidential care for teens vary according: (a) the adolescent's age and gender; and (b) the specific parental characteristics, e.g., gender, race/ethnicity, insurance status, education, religiosity. Secondly, how does parental knowledge and attitudes about confidential care for teens affect parental behavioral intentions to facilitate their teen's gaining knowledge and skills to be able to access STI preventive confidential services. This research would inform investigations how to strengthen the role of parents and encourage partnerships between health care providers and parents to ultimately improve the health outcomes for teens.
Hypotheses:
- Parental knowledge of confidential care for adolescents will increase parental intention to facilitate confidential care
- Parental knowledge of STI's will be positively associated with their perceptions of their teen's susceptibility to/ severity of STI
- Parental knowledge or suspicion that their adolescent is having sex will be associated with perceptions that their teen is susceptibility to STIs
- Parental knowledge of STI's and/or knowledge/ suspicion adolescent is having sex will be associated with parental intention to facilitate confidential care
- Perceived susceptibility/severity of their teen to STI will be associated with a greater intention to facilitate confidential care
- Perceived benefits of confidential care will be associated with an greater intention to facilitate confidential care
- Perceived risks/barriers to confidential care (e.g., logistical/billing; busy practice, no policy/time for provider to see teen alone; perceived increase risky teen behavior due to such sexual health discussions) will be negatively associated with intention to facilitate confidential care
- Perceived self-efficacy will be associated with an greater intention to facilitate confidential care
- Past behavior/experiences regarding confidential care for parent and/or adolescent will be associated with intention to facilitate confidential care
Specific Aims:
- To examine parental knowledge and attitudes of confidential health services related to STI care for adolescents
- To examine how parental knowledge and attitudes of confidentiality regarding STI and related health care services vary according to parent characteristics
- To examine how parental knowledge and attitudes of confidentiality regarding STI and related health care services vary according to child characteristics ii. To examine how parental knowledge and attitudes toward confidential STI care affects the parent's behavioral intentions to support their adolescent's access to confidential care iii. To identify key mechanisms that will form the basis of an intervention to improve parent-health care provider partnerships by giving parents knowledge and skills to help them facilitate their adolescent's access to confidential STI services as needed
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Male Parent/Guardians | – | –Male Parent/Guardian of Adolescent 12-17 yo. Health care members of either San Francisco General Hospital or Kaiser Permanente Northern California. |
| Female Parent/Guardian | – | –Female Parent/Guardian of Adolescent 12-17 yo. Health care members of either San Francisco General Hospital or Kaiser Permanente Northern California. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Parents/Guardians who have adolescents between 12-17 years of age
Key inclusion criteria (1 listed)
- Parents/Guardians who have adolescents between 12-17 years of age
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determining parental attitudes regarding confidential health services for their teens
Time frame: 4 years
Parental attitudes and knowledge regarding confidential health services will be assessed with focus groups, interviews and phone surveying.
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 28 Oct 2014.
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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.
Mary-Ann Shafer, MD principal investigator
University of California, San Francisco
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexually Transmitted Infections, run by University of California, San Francisco at 3 sites 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 1 inclusion and 0 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 28 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Determining parental attitudes regarding confidential health services for their teens (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2014.