Clinical trial NCT04560075: Text 2 Connect- Texting Intervention for Mental Health Treatment Utilization
Official title: ETUDES Center- Text2Connect - Phase 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Suicidal Ideation
Keywords: depression
suicidal ideation
treatment
mental health
text message intervention
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Kaiser Foundation Research Institute
name: National Institute of Mental Health (NIMH)
First posted: 2020-09-23
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will use a parallel study design, where participants are randomized into two intervention groups (T2C and PE) and will receive interventions in parallel.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Text2Connect (T2C) proposes to test a text-based intervention designed to improve engagement with mental health treatment.

Detailed description: To enhance outcomes for transition-age youth with mental health disorders during the vulnerable period that occurs during their first several months of college, the investigators propose an automated TM intervention, "Text to Connect" (T2C), that aims to increase mental health self-efficacy through psychoeducation, self-monitoring of symptoms and stressors, and cues to action for college-bound youth.

Assignment of Interventions:

The study will utilize block randomization whereby 2/3 of participants will be randomly assigned to receive T2C, and 1/3 to receive PE. Blocks will balance the groups on site (CCP versus STAR/CABS). A 2:1 randomization scheme will randomize 50 youth to either receive T2C (n=30) or a link to brief psychoeducational videos about mental health (PE; n=20). All participants will then complete a brief battery of self-report assessments online at baseline and again monthly through month 4. Youth randomized to receive PE will receive a text message with the link to the webpage with the psychoeducational videos. Youth randomized to receive T2C will be onboarded and initiate the TM intervention that sends automated prompts at minimum monthly through month 4.

Hypothesis:

Aim 1. To examine the feasibility of T2C for transition-age youth with psychiatric disorders (n=3 clinics, 50 adolescents). Youth randomized to receive T2C will:

Hypothesis 1a. engage with T2C at high rates (\>70% response rate to SMS prompts).

Hypothesis 1b. report high levels of satisfaction (\>70% satisfaction) and usability with T2C.

Aim 2. To examine the impact of T2C versus PE on mental health self-efficacy, symptoms and functioning, and treatment engagement. Over 4 months, youth who receive T2C, as compared with youth who receive PE, will report:

Hypothesis 2a (Primary). Greater mental health self-efficacy Hypothesis 2b (Secondary). Lower symptom severity and greater psychosocial functioning Hypothesis 2c (Secondary). Higher rates of follow-through with mental health services

Eligibility criteria: Inclusion Criteria:

* Participant engaged in treatment at CC Waterdam, STAR or CABS clinic
* Participants have a current psychiatric diagnosis documented in their electronic medical record and/or be in receipt of mental health services within 3 months per self-/ parent- or clinician- report
* At least 18 years of age
* Recently graduated high school
* Planning to attend college or higher education program within 6 weeks
* Own a text-capable phone
* Be willing and able to provide informed consent

Exclusion Criteria:

* Participants will be excluded if they have conditions that might impair their ability to effectively engage in Text2Connect
* Under the age of 18yo
* Non-English speakers

Primary outcomes:
measure: Engagement With Intervention: Text Message Check-ins
timeFrame: Over 3 months after baseline
measure: Engagement With Intervention: Web-based Check Ins
timeFrame: Over 3 months after baseline
measure: Engagement With Intervention: Drop Out Rate
timeFrame: Over 3 months after baseline
measure: Usability & Satisfaction-PSSUQ
timeFrame: 3 month follow up timepoint
measure: Usability & Satisfaction-CSQ
timeFrame: 3 month follow up timepoint
measure: Mental Health Self-Efficacy
timeFrame: 1 month timepoint
measure: Mental Health Self-Efficacy
timeFrame: 3 month timepoint
measure: Mental Health Self-Efficacy
timeFrame: 2 month timepoint
measure: General Self-Efficacy
timeFrame: 1 month Timepoint
measure: General Self-Efficacy
timeFrame: 2 month Timepoint
measure: General Self-Efficacy
timeFrame: 3 month Timepoint
Secondary outcomes:
measure: Psychosocial Functioning
timeFrame: 1 month timepoint
measure: Psychosocial Functioning
timeFrame: 2 month timepoint
measure: Psychosocial Functioning
timeFrame: 3 month timepoint
measure: Symptom Severity
timeFrame: 1 month timepoint
measure: Symptom Severity
timeFrame: 2 month timepoint
measure: Symptom Severity
timeFrame: 3 month timepoint
measure: Mental Health Service Follow-through
timeFrame: 1 month timepoint
measure: Mental Health Service Follow-through
timeFrame: 2 month timepoint
measure: Mental Health Service Follow-through
timeFrame: 3 month timepoint
Other outcomes:
Locations:
city: McMurray
country: United States
facility: Children's Community Pediatrics (CCP- Waterdam) of Children's Hospital of Pittsburgh UPMC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Child and Adolescent Bipolar Spectrum Services (CABS) Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: STAR Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Tina Goldstein, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh Medical Center
name: Brian Suffoletto, MD
role: STUDY_DIRECTOR
References:
citation: Suffoletto B, Goldstein T, Gotkiewicz D, Gotkiewicz E, George B, Brent D. Acceptability, Engagement, and Effects of a Mobile Digital Intervention to Support Mental Health for Young Adults Transitioning to College: Pilot Randomized Controlled Trial. JMIR Form Res. 2021 Oct 14;5(10):e32271. doi: 10.2196/32271.