NCT07064070

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Mar 2023Dec 2026

Study Start

First participant enrolled

March 1, 2023

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 14, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

July 14, 2025

Status Verified

July 1, 2025

Enrollment Period

3.6 years

First QC Date

June 25, 2025

Last Update Submit

July 2, 2025

Conditions

Keywords

mHealthadolescentsexual healthalone timewell child visit

Outcome Measures

Primary Outcomes (1)

  • 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)

    From enrollment to the end of intervention at 6 months

Secondary Outcomes (4)

  • Trustworthiness survey

    From enrollment to the end of intervention at 6 months

  • Parent-Adolescent Communication Scale (PACS)

    From enrollment to the end of intervention at 6 months

  • Parent-adolescent sexual risk communication scale (PTSRC-III):

    From enrollment to the end of intervention at 6 months

  • Supportive parenting survey

    From enrollment to the end of intervention at 6 months

Study Arms (1)

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

Behavioral: TRUST

Interventions

TRUSTBEHAVIORAL

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

participant will interact with four module on a secured website.

Eligibility Criteria

Age11 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Family Health care Nursing

San Francisco, California, 94143, United States

Location

Related Publications (1)

  • 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.

Related Links

Study Officials

  • Jyu-Lin Chen, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: participants have accessed to the intervention. Single arm study with pre and post design.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2025

First Posted

July 14, 2025

Study Start

March 1, 2023

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

July 14, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations