Menu
Enrolling by invitation NCT07064070

Technology-Based Resources to Increase Uptake of Sexual Health Services for Teens

No phase Interventional mHealth Intervention

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TRUST.
Who it may be relevant to
Registry conditions: mHealth Intervention. Basic parameters: 11 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

Alone time with healthcare providers is vital for adolescents, as recommended by several professional organizations, as it enhances health service utilization, empowers adolescents to manage their health, and facilitates discussions on sensitive issues. Despite its importance, only 40% of adolescents have private conversations with clinicians during visits. mHealth technology offers a promising solution for effective interventions to promote alone time with providers for adolescents, parents, and healthcare providers. This pilot study aims to evaluate the preliminary efficacy of a technology-based intervention designed to increase alone time with providers during well-adolescent visits (WAVs) and its impact on trustworthiness, parent-adolescent communication, sexual risk communication, parental monitoring, and parental support. After providing consent, participants accessed a study website to complete a baseline survey, interact with four modules, and complete a post-test survey one month after WAVs. Surveys assessed alone time, trustworthiness, parent-adolescent communication, sexual risk communication, parental monitoring, and parental support.

Detailed description

Background: Alone time with healthcare providers is critical for adolescents; several professional organizations recommend it. Alone time with providers promotes better utilization of health services, empowers adolescents to manage their health, and facilitates discussions on sensitive issues. However, only 40% of adolescents have private conversations with clinicians during visits. The advancement mHealth technology provides an excellent opportunity to deliver effective interventions to promote adolescent/provider alone time with adolescents, parents, and providers.

Objective: This pilot study aims to explore 1) the preliminary efficacy of a technology-based intervention designed to increase Alone time with providers during well-adolescent visits (WAVs) and 2) its impact on trustworthiness, parent-adolescent communication, sexual risk communication, parental monitoring, and parental support before and after the intervention.

Methods: A pre and post test design is utilized. After obtaining consent, participants accessed a study website to complete a baseline survey, interact with four modules, and complete a post-test survey one month after WAVs. Participants completed surveys assessing alone time, trustworthiness, parent-adolescent communication, sexual risk communication, parental monitoring, and parental support. Mixed model analysis and effect sizes for pre- and post-intervention outcomes were employed.

Interventions

  • Behavioral TRUST
    The four online modules included: General Communication, Talking about Relationships and Sexual Health, Parental Monitoring, and Check-up and Check-in (content focused on the importance of alone time). Modules were in English, Chinese, or Spanish

Primary outcome measures

  • Young Adult Health Care Survey (YAHCS) for Alone time [Time frame: From enrollment to the end of intervention at 6 months]
Secondary outcome measures (4)
  • Trustworthiness survey [Time frame: From enrollment to the end of intervention at 6 months]
  • Parent-Adolescent Communication Scale (PACS) [Time frame: From enrollment to the end of intervention at 6 months]
  • Parent-adolescent sexual risk communication scale (PTSRC-III): [Time frame: From enrollment to the end of intervention at 6 months]
  • Supportive parenting survey [Time frame: From enrollment to the end of intervention at 6 months]

Eligibility criteria

Inclusion criteria

  • The child is between 11 and 17 years old
  • The child can read and speak English
  • The child has access to the internet (via phone or computer)
  • The child has a well-child visit scheduled in the next 6 months.
  • Mother could be included if they had an adolescent enrolled in this study
  • Mother who speaks and reads English, Cantonese, Mandarin, or Spanish
  • Mother has access to the internet.

Exclusion criteria

  • Not have a well-child visit scheduled in the next 6 months.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Department of Family Health care Nursing — San Francisco

Publications

  • Chen JL, Raymond-Flesch M, Hoffmann TJ, Lin CX, Xu L, Koester KA. Evaluating the Preliminary Efficacy of the TRUST Intervention on Alone-Time and Communication During Well-Adolescent Visits: Quasi-Experimental Study. JMIR Pediatr Parent. 2025 Sep 8;8:e71433. doi: 10.2196/71433. PMID 40921058

Identifiers

NCT: NCT07064070 · 20-32013 · U48DP006374 DP20-003: SIP20-00 · U48DP006374

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗