Health TrialsbyHealthPanel

Flourish in Schools Pilot Study

ConditionsPsychological DistressSuicidal Ideation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age11-21
SponsorCandice Biernesser

About this trial

This study will test Flourish, a digital suicide prevention intervention for cyberbullied youth, within schools.

Specifically, the study aims to:

1. Examine if Flourish is effective and can be feasibly delivered within schools among middle and high school students who are experiencing cyberbullying and suicide risk factors. Feasibility will be evidenced by recruitment and retention rates to the study (\> or = 80%) and use of Flourish at least weekly among 80% of youth. Effectiveness will be evidenced by students reporting improvements in psychological distress and suicidal thoughts over the 3-month follow-up period. 2. Understand barriers or facilitators to Flourish's adoption within schools. We will conduct exit interviews and brief surveys with school personnel to inform optimal strategies for implementing Flourish within schools

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

11-21 years old

English-speaking

have access to a cell phone or tablet that can send/receive SMS text messages

identified as a student who could benefit from the program by a school staff member - OR - screened eligible based on experiencing cyberbullying and suicide risk factors in the past 3 months

Disqualifiers

if a student has a condition that might inhibit their ability to effectively engage with Flourish (e.g., intellectual challenges or low literacy levels)

if a students' level of acuity would suggest a higher level of care or referral to emergency services

if a school staff judges the intervention is not appropriate for the student

Trial design

Design model

Single group

Treatments tested in this trial

  • Flourish

    Device

    Flourish is a text messaging and web-based program that aims to improve coping following cyberbullying and reduce suicide risk among youth.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: FlourishExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Recruitment rates of eligible participants

Feasibility will be measured through recruitment rates of eligible participants, using a cut-off score of 80% for desirable recruitment rates.

Time frame
Assessed upon recruitment to the study
2

Retention rates of eligible participants

Feasibility will be measured through retention rates of eligible participants, using a cut-off score of 80% for desirable retention rates across the 12-week study period.

Time frame
Assessed upon completion of the Week 12 study visits
3

Level of intervention usage

Usage of the intervention will be assessed by engagement with Flourish at least weekly, on average, during the study period. A cut-off score of 70% of youth using the intervention at least weekly will be used as a minimum requirement for acceptable usage.

Time frame
Assessed upon completion of the 4-week intervention period

Secondary outcomes

1

Change in psychological distress from baseline to 2 weeks

Psychological distress will be measured by the Kessler 6-item psychological distress scale (K6). Total scale scores range from 0 to 24 with higher values indicating higher levels of distress and lower values indicating lower distress.

Time frame
Assessed at the baseline and Week 2 follow-up assessment visits
2

Change in psychological distress from baseline to 4 weeks

Psychological distress will be measured by the Kessler 6-item psychological distress scale. Total scale scores range from 0 to 24, higher values indicating higher levels of distress and lower values indicating lower distress.

Time frame
Assessed at the Week 4 follow-up assessment visits
3

Change in psychological distress from baseline to 12 weeks

Psychological distress will be measured by the Kessler 6-item psychological distress scale. Total scale scores range from 0 to 24, higher values indicating higher levels of distress and lower values indicating lower distress.

Time frame
Assessed at the Week 12 follow-up assessment visits
4

Change in severity of suicidal ideation and behavior from baseline to 4 weeks

Severity of suicidal ideation and behavior will be measured with the Columbia Suicide Severity Rating Scale (C-SSRS), an interviewer-rated measure. Presence of suicidal ideation and behavior will be indicated with yes/no response options. Intensity of ideation will be rated on a scale from 1-5 with higher numbers reflecting higher levels of intensity and lower numbers reflecting lower levels of intensity.

Time frame
Assessed at baseline and Week 4 follow-up assessment visits

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Candice Biernesser

Lead sponsor

University of Pittsburgh

Sponsor institution

National Institute of Mental Health (NIMH)

Collaborator

The Pittsburgh Foundation

Collaborator

Source ClinicalTrials.gov
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