Clinical trial NCT06842576: Health Care Transition Readiness Short-Form Video Intervention
Official title: Transition Readiness Mobile Health Intervention: Co-Design and Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Health Care Transition Readiness
Health Literacy
Self Efficacy
Emotional Wellbeing
Appointment Attendance
Keywords: mobile health
health education
transition readiness
chronic illness
adolescence
health literacy
social media
video
self efficacy
emotional wellbeing
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
First posted: 2025-02-24
Enrollment: 44
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: pilot parallel randomized controlled trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this clinical trial is to assess whether social-media style short-form health education videos can increase health care transition readiness, self-efficacy, emotional well-being, health literacy, and appointment attendance, compared with publicly available health education resources in adolescents with chronic illnesses. The main question it aims to answer is:

-Hypothesize social media intervention will increase health care transition readiness, self-efficacy, emotional well-being, health literacy, and appointment attendance compared to publicly available health education website immediately post intervention and at 6 month follow up.

Participants will be randomly assigned to one of the interventions and access the intervention for 20 minutes and complete 30-60 minutes of surveys.


Eligibility criteria: Inclusion Criteria:

* Patients in subspecialty clinics
* Between 12 and 17 years old
* With access to an internet-connected device
* Speaking English or Spanish
* With sufficient cognitive capacity to understand the study procedures, as assessed via a teach back method.

Exclusion Criteria:

* none

Primary outcomes:
measure: Self-reported score with a range from 1-5, on the Transition Readiness Assessment Questionnaire (TRAQ).
timeFrame: Immediate post-treatment and 6-month follow-up.
measure: Self-reported score ranging from 1 to 4, via the Generalized Self-Efficacy Scale (GSES).
timeFrame: Immediate post-treatment and 6-month follow-up.
measure: Self-reported score ranging from 1 to 5, via the Positive and Negative Affect Schedule for Children and Adolescents (PANAS-C).
timeFrame: Immediate post-treatment and 6-month follow-up.
measure: Self-report questionnaire with a score ranging from 10 to 40, via the Health Literacy for Youth.
timeFrame: Immediate post-treatment and 6-month follow-up.
measure: Number of appointments attended divided by the number of appointments scheduled, producing a score ranging from 0 to 100%, via medical chart abstraction.
timeFrame: Comparing 6 months before intervention to 6 months after intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children Hospital Los Angeles
state: California
Study officials:
affiliation: Children's Hospital Los Angeles
name: Caitlin S Sayegh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carrera Diaz K, Yau J, Iverson E, Cuevas R, Porter C, Morales L, Tut M, Santiago A, Ghavami S, Reich E, Sayegh CS. Human-centered design approach to building a transition readiness mHealth intervention for early adolescents. J Pediatr Psychol. 2025 Jan 1;50(1):106-114. doi: 10.1093/jpepsy/jsae066.
citation: Bal MI, Sattoe JN, Roelofs PD, Bal R, van Staa A, Miedema HS. Exploring effectiveness and effective components of self-management interventions for young people with chronic physical conditions: A systematic review. Patient Educ Couns. 2016 Aug;99(8):1293-309. doi: 10.1016/j.pec.2016.02.012. Epub 2016 Mar 3.
citation: Modi AC, Pai AL, Hommel KA, Hood KK, Cortina S, Hilliard ME, Guilfoyle SM, Gray WN, Drotar D. Pediatric self-management: a framework for research, practice, and policy. Pediatrics. 2012 Feb;129(2):e473-85. doi: 10.1542/peds.2011-1635. Epub 2012 Jan 4.