mHealth InterventionTRUSTNCT07064070
Technology-Based Resources to Increase Uptake of Sexual Health Services for Teens
A study testing TRUST in people with mHealth Intervention, run by University of California, San Francisco at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 11 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- mHealth Intervention
- What is being tested?
- TRUST
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 11 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Not have a well-child visit scheduled in the next 6 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Department of Family Health care Nursing
San Francisco, California, 94143
About this study
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.
Read the 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.
- Conditions
- mHealth Intervention
- Being tested
- TRUST
- Keywords
- mHealth, adolescent, sexual health, alone time, well child visit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRUSTBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| participant will interact with four module on a secured website. | Experimental | The 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 Receives: Behavioral: TRUST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Young Adult Health Care Survey (YAHCS) for Alone time
Whether the adolescent had alone time with a healthcare provider (one-on-one communication without a parent) during the last well-adolescent visits (WAVs)
Measured: From enrollment to the end of intervention at 6 months
Secondary outcomes (4)
Trustworthiness survey
The construct of perceived trustworthiness was assessed using three items for adolescents and their mothers. Three items include: I can trust my mother/adolescent when we talk, b) my mother /adolescent keeps her promises to me, and c) my mother/adolescent is honest with me. Score ranges from 1 to 5, with a higher score indicating a higher level of trust.
Measured: From enrollment to the end of intervention at 6 months
Parent-Adolescent Communication Scale (PACS)
A survey consists of 20 items that measure the quality of communication between adolescents and their parents. The score ranges from 1 to 5. Higher scores represent better parent-adolescent communication.
Measured: From enrollment to the end of intervention at 6 months
Parent-adolescent sexual risk communication scale (PTSRC-III):
an 8-item scale used to assess the extent of sexual risk communication between adolescents and their parents. The scores range from 1 to 5 with a high score indicating a better parent-teen sexual risk communication. Higher values indicate more supportive parenting.
Measured: From enrollment to the end of intervention at 6 months
Supportive parenting survey
Mothers reported how often they support their child (three items; 4-point Likert scale; Never to Always).
Measured: From enrollment to the end of intervention at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start1 Mar 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for mHealth InterventionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- participants have accessed to the intervention. Single arm study with pre and post design.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Jyu-Lin Chen, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07064070
- Sponsor's protocol ID
- 20-32013
- Other IDs
- U48DP006374 DP20-003: SIP20-00, U48DP006374
- Acronym
- TRUST
- Status last verified
- Jul 2025
- First submitted
- 25 Jun 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 40921058
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology-Based Resources to Increase Uptake of Sexual Health Services for Teens
- ClinicalTrials.gov ID
- NCT07064070
- Acronym / sponsor ID
- TRUST / 20-32013
- Conditions
- mHealth Intervention
- Keywords
- mHealth, adolescent, sexual health, alone time, well child visit
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 14 Jul 2025 (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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- participants have accessed to the intervention. Single arm study with pre and post design.
| Arm | Type | Receives |
|---|---|---|
| participant will interact with four module on a secured website. | Experimental | Behavioral: TRUSTThe 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 |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Not have a well-child visit scheduled in the next 6 months.
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 |
|---|---|---|
| TRUSTThe 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 | Behavioural | participant will interact with four module on a secured website. |
Primary outcome
Young Adult Health Care Survey (YAHCS) for Alone time
Time frame: From enrollment to the end of intervention at 6 months
Whether the adolescent had alone time with a healthcare provider (one-on-one communication without a parent) during the last well-adolescent visits (WAVs)
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Derived from this study: PubMed 40921058Chen 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.
- TRUST StudyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Jyu-Lin Chen, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRUST in people with mHealth Intervention, run by University of California, San Francisco 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 7 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 14 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Young Adult Health Care Survey (YAHCS) for Alone time (time frame: From enrollment to the end of intervention at 6 months). 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 NCT07064070, which also lists 1 linked publication.
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 14 Jul 2025.