Teen Recovery Through Inspiration, Support, and Empowerment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-18
SponsorUniversity of Texas Southwestern Medical Center
About this trial
The goal of this pilot study is to test the effectiveness of a novel intervention for teenagers (ages 15-18) with mental health conditions who have been released from an acute care psychiatric facility. The intervention aims to reduce suicidality, depression, anxiety, re-hospitalization, and to improve mental health recovery by using an online recovery education and support program.
The current standard of care (SOC) for these patients at discharge includes a discharge plan with a list of their medication(s), anticipated outpatient appointment(s), and corresponding information on when and where to find community resources.
The intervention being tested involves the implementation of an online recovery education and support (RES) program, involving one-on-one and small group meetings led by trained teen peers (TPs) and peer support specialists (PSS).
Participants will be assigned to either Cohort A or B for 8 weeks.
Cohort A will be the intervention group with online access to an RES, TP, and PSS.
* Week 1-4: One-on-one meetings with PSS and TP for education and support. Assessments will be completed at week 2 and 4. * Week 5 and 7: one-one meetings with PSS and TP for education and support. * Week 6 and 8: small group meetings with PSS, TP, and other participants. Assessments will be completed during Weeks 6 and 8.
Cohort B will be the SOC group with no PSS, TP, or RES.
* Weeks 1-4: Weekly check in phone calls with a member of the research team. Assessments will be completed at Weeks 2 and 4. * Weeks 5-8: Check in phone calls with a member of the research team every other week. Assessments will be completed at weeks 6 and8.
Data collected from participant assessments, adherence to medication, and re-admittance to a psychiatric facility will be used to compare the intervention to the SOC.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Chief complaint of suicidal ideation, suicide attempt, depression, and/or anxiety
recently discharged from inpatient care or from emergency department
men and women ages 15-18 years old
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Peer Support Services Recovery
BehavioralA program of mental health recovery through one-on-one and small group meetings with a PSS and TP using RES for individuals recently discharged from an acute care psychiatric facility.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Cohort A: Intervention Group with PSS, TP, and RESExperimental treatment 1 intervention
Group B: Cohort B: Standard of CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in Suicidal Ideation as measured by C-SSRS at 2 weeks from baseline
Change in suicidal ideation is measured by Columbia Suicide Severity Rating Scale (C-SSRS) at 2 weeks from baseline using both the baseline and since last visit assessment versions. Scoring of the assessment indicates severity. The C-SSRS consists of 16 questions that ask about suicidal ideation and behaviors (the first 10 questions comprise the ideation subscale and the last 6 comprise the behavior subscale). Total score ranges for suicidal ideation from a minimum of 0 (corresponding to no suicidal ideation) to a maximum of 5 (representing active suicidal ideation with plan and intent). Total score ranges for suicidal behavior from a minimum of 0 (corresponding to no suicidal behavior) to a maximum of 5 (representing active suicidal behavior).
Time frame
Baseline, 2 weeks2
Change in Suicidal Ideation as measured by C-SSRS at 4 weeks from baseline
Change in suicidal ideation is measured by Columbia Suicide Severity Rating Scale (C-SSRS) at 4 weeks from baseline using both the baseline and since last visit assessment versions. Scoring of the assessment indicates severity. The C-SSRS consists of 16 questions that ask about suicidal ideation and behaviors (the first 10 questions comprise the ideation subscale and the last 6 comprise the behavior subscale). Total score ranges for suicidal ideation from a minimum of 0 (corresponding to no suicidal ideation) to a maximum of 5 (representing active suicidal ideation with plan and intent). Total score ranges for suicidal behavior from a minimum of 0 (corresponding to no suicidal behavior) to a maximum of 5 (representing active suicidal behavior).
Time frame
Baseline, 4 weeks3
Change in Suicidal Ideation as measured by C-SSRS at 6 weeks from baseline
Change in suicidal ideation is measured by Columbia Suicide Severity Rating Scale (C-SSRS) at 6 weeks from baseline using both the baseline and since last visit assessment versions. Scoring of the assessment indicates severity. The C-SSRS consists of 16 questions that ask about suicidal ideation and behaviors (the first 10 questions comprise the ideation subscale and the last 6 comprise the behavior subscale). Total score ranges for suicidal ideation from a minimum of 0 (corresponding to no suicidal ideation) to a maximum of 5 (representing active suicidal ideation with plan and intent). Total score ranges for suicidal behavior from a minimum of 0 (corresponding to no suicidal behavior) to a maximum of 5 (representing active suicidal behavior).
Time frame
Baseline, 6 weeks4
Change in Suicidal Ideation as measured by C-SSRS at 8 weeks from baseline
Change in suicidal ideation is measured by Columbia Suicide Severity Rating Scale (C-SSRS) at 8 weeks from baseline using both the baseline and since last visit assessment versions. Scoring of the assessment indicates severity. The C-SSRS consists of 16 questions that ask about suicidal ideation and behaviors (the first 10 questions comprise the ideation subscale and the last 6 comprise the behavior subscale). Total score ranges for suicidal ideation from a minimum of 0 (corresponding to no suicidal ideation) to a maximum of 5 (representing active suicidal ideation with plan and intent). Total score ranges for suicidal behavior from a minimum of 0 (corresponding to no suicidal behavior) to a maximum of 5 (representing active suicidal behavior).
Time frame
Baseline, 8 weeksSecondary outcomes
1
Changes in symptoms associated with anxiety as measured by GAD 7 at 2 weeks
A reduction of anxiety symptoms and rates of occurrence will be measured using the Generalized Anxiety Disorder (GAD) 7 - a widely used screening tool for assessing the severity of generalized anxiety disorder (GAD) and consists of 7 items that evaluate anxiety symptoms with 4 response options: 0- "Not at all", 1-"Several days", 2-"More than half the days", 3-"Nearly every day". Total score can range from 0 to 21 with higher scores indicating higher levels of anxiety.
Time frame
Baseline, 2 weeks2
Changes in symptoms associated with anxiety as measured by GAD 7 at 4 weeks
A reduction of anxiety symptoms and rates of occurrence will be measured using the Generalized Anxiety Disorder (GAD) 7 - a widely used screening tool for assessing the severity of generalized anxiety disorder (GAD) and consists of 7 items that evaluate anxiety symptoms with 4 response options: 0- "Not at all", 1-"Several days", 2-"More than half the days", 3-"Nearly every day". Total score can range from 0 to 21 with higher scores indicating higher levels of anxiety.
Time frame
Baseline, 4 weeks3
Changes in symptoms associated with anxiety as measured by GAD 7 at 6 weeks
A reduction of anxiety symptoms and rates of occurrence will be measured using the Generalized Anxiety Disorder (GAD) 7 - a widely used screening tool for assessing the severity of generalized anxiety disorder (GAD) and consists of 7 items that evaluate anxiety symptoms with 4 response options: 0- "Not at all", 1-"Several days", 2-"More than half the days", 3-"Nearly every day". Total score can range from 0 to 21 with higher scores indicating higher levels of anxiety.
Time frame
Baseline, 6 weeks4
Changes in symptoms associated with anxiety as measured by GAD 7 at 8 weeks
A reduction of anxiety symptoms and rates of occurrence will be measured using the Generalized Anxiety Disorder (GAD) 7 - a widely used screening tool for assessing the severity of generalized anxiety disorder (GAD) and consists of 7 items that evaluate anxiety symptoms with 4 response options: 0- "Not at all", 1-"Several days", 2-"More than half the days", 3-"Nearly every day". Total score can range from 0 to 21 with higher scores indicating higher levels of anxiety.
Time frame
Baseline, 8 weeksSponsors and contacts
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Source ClinicalTrials.gov