Parental Knowledge and Attitudes of Confidential Sexually Transmitted Infections (STI) Services for Teens

• ClinicalTrials.gov Identifier: NCT01144871
• Recruitment Status: Completed
• First Posted: June 16, 2010
• Last Update Posted: October 28, 2014
• Sponsor: University of California, San Francisco
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Kaiser Permanente
• Information provided by (Responsible Party): University of California, San Francisco

Tracking Information

• First Submitted Date: June 14, 2010
• First Posted Date: June 16, 2010
• Last Update Posted Date: October 28, 2014
• Study Start Date: September 2007
• Actual Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 15, 2010)

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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Parental Knowledge and Attitudes of Confidential Sexually Transmitted Infections (STI) Services for Teens
• Official Title: Parental Knowledge and Attitudes of Confidential STI Services for Teens
• Brief 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. 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:

1. Parental knowledge of confidential care for adolescents will increase parental intention to facilitate confidential care
2. Parental knowledge of STI's will be positively associated with their perceptions of their teen's susceptibility to/ severity of STI
3. Parental knowledge or suspicion that their adolescent is having sex will be associated with perceptions that their teen is susceptibility to STIs
4. Parental knowledge of STI's and/or knowledge/ suspicion adolescent is having sex will be associated with parental intention to facilitate confidential care
5. Perceived susceptibility/severity of their teen to STI will be associated with a greater intention to facilitate confidential care
6. Perceived benefits of confidential care will be associated with an greater intention to facilitate confidential care
7. 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
8. Perceived self-efficacy will be associated with an greater intention to facilitate confidential care
9. Past behavior/experiences regarding confidential care for parent and/or adolescent will be associated with intention to facilitate confidential care

Specific Aims:

i. To examine parental knowledge and attitudes of confidential health services related to STI care for adolescents

1. To examine how parental knowledge and attitudes of confidentiality regarding STI and related health care services vary according to parent characteristics
2. 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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Cross-Sectional
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Parents/Guardians who have adolescents between 12-17 years of age
• Condition: Sexually Transmitted Infections
• Intervention: Not Provided

Study Groups/Cohorts

• 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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 25, 2014): 1216
• Original Estimated Enrollment (submitted: June 15, 2010): 2295
• Actual Study Completion Date: August 2011
• Actual Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Parents/Guardians who have adolescents between 12-17 years of age

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01144871
• Other Study ID Numbers: H1095-31348; R01HD053408-01A2 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University of California, San Francisco
• Study Sponsor: University of California, San Francisco

Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Kaiser Permanente

Investigators

• Principal Investigator: Mary-Ann Shafer, MD; University of California, San Francisco

• PRS Account: University of California, San Francisco
• Verification Date: October 2014