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Practice Experiences for School Reintegration
NA trial testing Safety Planning in Suicide in 54 participants. Completed in 20 December 2024.
| Lead sponsor | University of North Carolina, Chapel Hill |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | factorial |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 54 |
| Start date | 1 August 2023 |
| Primary completion | 20 December 2024 |
| Estimated completion | 20 December 2024 |
| Sites | 1 location across United States |
University of North Carolina, Chapel Hill
Adults 13 to 99, any sex, with Suicide. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Recruitment rate was determined based on the proportion of adolescents providing assent and parents or legal guardians providing permission relative to the number of parents or legal guardians approached.
| Group | Value | 95% CI |
|---|---|---|
| All Potential Adolescent Participants Who Were Approached | 0.384 |
Rate of recruitment related to motion sickness was determined based on the proportion of assented adolescents whose scores were \>/= than 50th percentile on motion sickness questionnaire relative to the number of assented adolescents.
| Group | Value | 95% CI |
|---|---|---|
| All Assented Adolescent Participants | 0.021 |
Proportion of participants who complete all study procedures was determined based on the proportion of adolescents completing study procedures at Baseline, 2-week follow-up, 3-month follow-up, and journals over the two weeks of their return to school relative to the total number of adolescents participating in that condition.
| Group | Value | 95% CI |
|---|---|---|
| Enhanced Control | 0 | |
| Affect Regulation | 0.800 | |
| Problem Solving | 0.167 | |
| Affect Regulation + Problem Solving | 0 | |
| Cognitive Restructuring | 0.400 | |
| Affect Regulation + Cognitive Restructuring | 0 | |
| Cognitive Restructuring + Problem Solving | 0.400 | |
| Affect Regulation + Cognitive Restructuring + Problem Solving | 0.200 |
Time to complete assessments, assessments are expected to last less than 4 hours. Note that the number of participants to start a Period is not equal to the number who completed previous Period for "Affect Regulation + Problem Solving" and "Cognitive Restructuring + Problem Solving" because 1 participant in each condition was withdrawn or withdrew.
| Group | Value | 95% CI |
|---|---|---|
| Enhanced Control | 0.603 | ± 0.182 |
| Affect Regulation | 0.847 | ± 0.197 |
| Problem Solving | 0.842 | ± 0.333 |
| Affect Regulation + Problem Solving | 0.762 | ± 0.219 |
| Cognitive Restructuring | 0.900 | ± 0.365 |
| Affect Regulation + Cognitive Restructuring | 0.747 | ± 0.220 |
| Cognitive Restructuring + Problem Solving | 1.079 | ± 0.414 |
| Affect Regulation + Cognitive Restructuring + Problem Solving | 0.780 | ± 0.177 |
| Group | Value | 95% CI |
|---|---|---|
| Enhanced Control | 0.357 | ± 0.056 |
| Affect Regulation | 0.550 | ± 0.272 |
| Problem Solving | 0.608 | ± 0.431 |
| Affect Regulation + Problem Solving | 0.242 | ± 0.073 |
| Cognitive Restructuring | 0.613 | ± 0.364 |
| Affect Regulation + Cognitive Restructuring | 0.667 | ± 0.426 |
| Cognitive Restructuring + Problem Solving | 0.562 | ± 0.299 |
| Affect Regulation + Cognitive Restructuring + Problem Solving | 0.563 | ± 0.289 |
| Group | Value | 95% CI |
|---|---|---|
| Enhanced Control | 1.242 | ± 0.365 |
| Affect Regulation | 0.621 | ± 0.138 |
| Problem Solving | 1.208 | ± 0.620 |
| Affect Regulation + Problem Solving | 0.761 | ± 0.281 |
| Cognitive Restructuring | 0.933 | ± 0.094 |
| Affect Regulation + Cognitive Restructuring | 1.133 | ± 0.306 |
| Cognitive Restructuring + Problem Solving | 1.342 | ± 0.884 |
| Affect Regulation + Cognitive Restructuring + Problem Solving | 0.644 | ± 0.287 |
| Group | Value | 95% CI |
|---|---|---|
| Enhanced Control | .500 | ± NA |
| Affect Regulation | .653 | ± 0.245 |
| Problem Solving | 1.044 | ± 0.474 |
| Affect Regulation + Problem Solving | 0.250 | ± NA |
| Cognitive Restructuring | 0.592 | ± 0.295 |
| Affect Regulation + Cognitive Restructuring | 0.958 | ± 0.295 |
| Cognitive Restructuring + Problem Solving | 1.017 | ± 0.731 |
| Affect Regulation + Cognitive Restructuring + Problem Solving | 0.983 | ± NA |
Time to complete intervention sessions, each session is expected to last less than 60 minutes. Average calculated by summing all sessions in each condition and dividing by total number of sessions. Note that the number of participants to start a Period is not equal to the number who completed previous Period for "Affect Regulation + Problem Solving" and "Cognitive Restructuring + Problem Solving" because 1 participant in each condition was withdrawn or withdrew.
| Group | Value | 95% CI |
|---|---|---|
| Affect Regulation | 26.864 | ± 12.241 |
| Problem Solving | 26.333 | ± 12.473 |
| Affect Regulation + Problem Solving | 27.500 | ± 12.103 |
| Cognitive Restructuring | 25.938 | ± 13.188 |
| Affect Regulation + Cognitive Restructuring | 37.083 | ± 15.197 |
| Cognitive Restructuring + Problem Solving | 29.714 | ± 16.838 |
| Affect Regulation + Cognitive Restructuring + Problem Solving | 30.522 | ± 14.145 |
Percentage of participants in which adherence to delivery of key components of intervention (i.e., skill lessons or practice sessions) across sessions in each condition was 80% or greater. Adherence was calculated based on the number of key components completed relative to the total number of key components expected to be completed for each participant. Note that the number of participants to start a Period is not equal to the number who completed previous Period for "Affect Regulation + Problem Solving" and "Cognitive Restructuring + Problem Solving" because 1 participant in each condition wa
| Group | Value | 95% CI |
|---|---|---|
| Affect Regulation | 100 | |
| Problem Solving | 100 | |
| Affect Regulation + Problem Solving | 100 | |
| Cognitive Restructuring | 100 | |
| Affect Regulation + Cognitive Restructuring | 100 | |
| Cognitive Restructuring + Problem Solving | 100 | |
| Affect Regulation + Cognitive Restructuring + Problem Solving | 100 |
Percent of adolescents with average acceptability score less than or equal to 2 (or "agree") on a five-point scale from 1 (strongly agree) to 5 (strongly disagree). Note that the number of participants to start a Period is not equal to the number who completed previous Period for "Affect Regulation + Problem Solving" and "Cognitive Restructuring + Problem Solving" because 1 participant in each condition was withdrawn or withdrew, and due to missing post-baseline data for "Problem Solving" (1 participant), "Cognitive Restructuring" (1 participant), "Affect Regulation + Cognitive Restructuring"
| Group | Value | 95% CI |
|---|---|---|
| Affect Regulation | 60 | |
| Problem Solving | 60 | |
| Affect Regulation + Problem Solving | 100 | |
| Cognitive Restructuring | 75 | |
| Affect Regulation + Cognitive Restructuring | 50 | |
| Cognitive Restructuring + Problem Solving | 100 | |
| Affect Regulation + Cognitive Restructuring + Problem Solving | 100 |
Percent of hospital professionals with average acceptability score less than or equal to 2 (or "agree") on a five-point scale from 1 (strongly agree) to 5 (strongly disagree). Note that the number of participants to start a Period is not equal to the number who completed previous Period for Hospital Professionals because 7 professionals consented into the study, but only 4 delivered the intervention to a patient following consent.
| Group | Value | 95% CI |
|---|---|---|
| Hospital Professionals | 25 |
Qualitative feedback provided by adolescents receiving the intervention in the Optimization Trial about acceptability of the intervention. Note that the number of participants to start a Period is not equal to the number who completed previous Period for "Affect Regulation + Problem Solving" and "Cognitive Restructuring + Problem Solving" because 1 participant in each condition was withdrawn or withdrew, and due to missing post-baseline data for "Cognitive Restructuring + Problem Solving" (1 participant).
| Group | Value | 95% CI |
|---|---|---|
| Affect Regulation | 5 | |
| Problem Solving | 6 | |
| Affect Regulation + Problem Solving | 4 | |
| Cognitive Restructuring | 5 | |
| Affect Regulation + Cognitive Restructuring | 4 | |
| Cognitive Restructuring + Problem Solving | 4 | |
| Affect Regulation + Cognitive Restructuring + Problem Solving | 5 |
| Group | Value | 95% CI |
|---|---|---|
| Affect Regulation | 5 | |
| Problem Solving | 6 | |
| Affect Regulation + Problem Solving | 4 | |
| Cognitive Restructuring | 5 | |
| Affect Regulation + Cognitive Restructuring | 4 | |
| Cognitive Restructuring + Problem Solving | 4 | |
| Affect Regulation + Cognitive Restructuring + Problem Solving | 5 |
| Group | Value | 95% CI |
|---|---|---|
| Affect Regulation | 1 | |
| Problem Solving | 0 | |
| Affect Regulation + Problem Solving | 0 | |
| Cognitive Restructuring | 0 | |
| Affect Regulation + Cognitive Restructuring | 0 | |
| Cognitive Restructuring + Problem Solving | 0 | |
| Affect Regulation + Cognitive Restructuring + Problem Solving | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Affect Regulation | 0 | |
| Problem Solving | 3 | |
| Affect Regulation + Problem Solving | 0 | |
| Cognitive Restructuring | 1 | |
| Affect Regulation + Cognitive Restructuring | 3 | |
| Cognitive Restructuring + Problem Solving | 1 | |
| Affect Regulation + Cognitive Restructuring + Problem Solving | 1 |
Qualitative feedback provided by Hospital Professionals delivering the intervention to one or more hospitalized adolescents about acceptability of the intervention. Note that the number of participants to start a Period is not equal to the number who completed previous Period for Hospital Professionals because 7 professionals consented into the study, but only 4 delivered the intervention to a patient following consent.
| Group | Value | 95% CI |
|---|---|---|
| Hospital Professionals | 4 |
| Group | Value | 95% CI |
|---|---|---|
| Hospital Professionals | 4 |
Time frame: For the Optimization Trial, from signing the informed consent until the 3-Month Return to School Follow-Up or early withdrawal. This time was dependent on the duration of hospital stay and timing of return to school and therefore varied greatly (ranging from 1 day to 405 days). For the Open Trial Period, adverse events for the Adolescent Patients Selected by Hospital Professionals were only monitored during intervention delivery.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Enhanced Control | Affect Regulation | Problem Solving | Affect Regulation + Proble… | Cognitive Restructuring | Affect Regulation + Cognit… | Cognitive Restructuring + … | Affect Regulation + Cognit… | Hospital Professionals | Adolescent Patients Select… |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Emergency Department Visit for Suicide-Related Risk or Associated Symptoms | Psychiatric disorders | — | — | — | — | — | — | — | — | — | — |
| Hospitalization for Suicide-Related Risk or Associated Symptoms | Psychiatric disorders | — | — | — | — | — | — | — | — | — | — |
| Hospitalization for Medical Procedure: GI | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — | — |
| Hospitalization for Medical Procedure: Skin | Skin and subcutaneous tissue disorders | — | — | — | — | — | — | — | — | — | — |
| Parent Distress Related to Adolescent Risk Behaviors | Psychiatric disorders | — | — | — | — | — | — | — | — | — | — |
| Reaction | System | Enhanced Control | Affect Regulation | Problem Solving | Affect Regulation + Proble… | Cognitive Restructuring | Affect Regulation + Cognit… | Cognitive Restructuring + … | Affect Regulation + Cognit… | Hospital Professionals | Adolescent Patients Select… |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Distress | Social circumstances | — | — | — | — | — | — | — | — | — | — |
| Medical Procedure or Action | Surgical and medical procedures | — | — | — | — | — | — | — | — | — | — |
| Medical Action | Vascular disorders | — | — | — | — | — | — | — | — | — | — |
Most-reported serious reactions: Emergency Department Visit for Suicide-Related Risk or Associated Symptoms, Hospitalization for Suicide-Related Risk or Associated Symptoms, Hospitalization for Medical Procedure: GI, Hospitalization for Medical Procedure: Skin, Parent Distress Related to Adolescent Risk Behaviors.
Data from ClinicalTrials.gov NCT05934396 adverse events section.
This study is developing and refining a novel Virtual Reality (VR) supplement for inpatient treatment: the Practice Experiences for School Reintegration (PrESR) program. The PrESR will provide immersive school experiences for inpatient adolescents (with suicidal-related admissions) to practice skills in real-world settings with the guidance of a trained clinician within the confines of a hospital. This pilot study follows a Multiphase Optimization Strategy (MOST) to conduct a pilot optimization trial of the PrESR to inform the feasibility of training clinicians, the ability to recruit adolescent inpatient participants, and management of experimental conditions. This study is not powered to test hypotheses; however, in addition to assessing feasibility and acceptability, this pilot trial will assess candidate intermediary and outcome measures.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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