SAFETY-Parent: Online Learning Module to Support Parents of Suicidal Youth
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Use of intervention as measured by information provided by the Brainer Learning Management System (LMS)
研究概览
简要总结
This project aims to adapt the parent component of Safe Alternatives for Teens and Youth (SAFETY) outpatient intervention to SAFETY-Parent (SAFETY-P), a self-paced interactive learning module for parents, to be implemented as an augmentation for youth being seen for suicidal ideation, suicidal behavior, or recent suicide attempts across multiple settings at Nationwide Children's Hospital (NCH, Columbus, Ohio).
详细描述
This research project has iterative aims focused on the development and pilot testing of the SAFETY-P asynchronous parent intervention module. Phase 1 will focus on finalizing SAFETY-P content for the online learning module. Phase 2 will be a small open case series integrating additional key stakeholder feedback via formative usability testing. Phase 3 will test the revised module in a pilot RCT, to establish methods and protocols for a future large-scale clinical trial.
Phase 1/Aim 1 (Intervention Adaptation for Online Delivery): Phase 1 will include 4 separate stakeholder focus groups (adolescents, parents, behavioral health [BH] inpatient and outpatient providers, and parent survivors of suicide loss) to advise on adaptations to SAFETY-P and development of the self-paced, interactive module to be used in Phase 2.
Aim 1: Adapt the parent component of SAFETY to content for the SAFETY-P asynchronous parent intervention module and determine feasibility and acceptability of SAFETY-P to this asynchronous module delivery.
Hypothesis (Hyp) 1.1: SAFETY content will be adapted successfully to SAFETY-P; stakeholders will report that use of an online asynchronous learning module for parents is feasible and acceptable based on qualitative coding outcomes.
Phase 2/Aim 1 (Case Series Iterative Adaptation): Phase 2 will include pilot testing of SAFETY-P with a nonrandomized case series of 5 clinicians and 10 families. Participants will be invited to use SAFETY-P for up to one month. Feedback from this case series will inform iterative adaptations to the SAFETY-P module.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Independent evaluators, masked to condition, will conduct outcome assessments with parents and youth at baseline,1-month (the typical length of TAU in CATC prior to linking youth patients to ongoing outpatient care), and 3-month follow-up.
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For Phase 1 interviews and focus groups:
- •1. Youth or young adults (<25 years) with prior suicidal ideation or suicide attempts; parents whose child had a history of suicidal ideation and/or suicide attempt before age 18; medical or behavioral health provider of suicidal youth; and parents whose child died from suicide before age 18
- •For Phase 2 and the Phase 3:
- •Youth is currently in treatment with the Critical Assessment and Treatment Clinic (CATC) at NCH for suicidal thoughts or behaviors
- •Youth is between the ages of 10-18 (18-year-old youth must still be in high school and living at home with parents for duration of the study)
- •At least one parent is able to participate
- •Youth and parent are fluent in English
排除标准
- •For all four Phase 1 groups:
- •1. Cannot read or speak English (given focus group to be conducted in English
- •For Phase 2 and Phase 3 participants:
- •The youth or parent has an acute psychiatric or medical condition that would interfere with their ability to participate in study procedures
- •Lack of access to a digital device (smartphone, iPad, tablet computer, desktop, laptop PC)
研究组 & 干预措施
Safe Alternatives for Teens and Youth - Parent (SAFETY-P) + Treatment as Usual (TAU)
Phase 2 will include pilot testing of the SAFETY-P asynchronous parent intervention module with a nonrandomized case series of 10 families receiving services in CATC. Participants will be provided with the SAFETY-P modules and complete follow-up measures after one month.
Phase 3 will include an RCT with N = 30 youth and parents, with half randomized to SAFETY-P + treatment as usual (TAU). Participants will complete measures at baseline, 1 month, and 3 months.
干预措施: Safe Alternatives for Teens and Youth - Parent (SAFETY-P) (Behavioral)
Safe Alternatives for Teens and Youth - Parent (SAFETY-P) + Treatment as Usual (TAU)
Phase 2 will include pilot testing of the SAFETY-P asynchronous parent intervention module with a nonrandomized case series of 10 families receiving services in CATC. Participants will be provided with the SAFETY-P modules and complete follow-up measures after one month.
Phase 3 will include an RCT with N = 30 youth and parents, with half randomized to SAFETY-P + treatment as usual (TAU). Participants will complete measures at baseline, 1 month, and 3 months.
干预措施: Treatment As Usual (TAU) (Behavioral)
Treatment As Usual (TAU)
Phase 3 will include an RCT with N = 30 youth and parents, with half randomized treatment as usual (TAU). Participants will complete measures at baseline, 1 month, and 3 months.
干预措施: Treatment As Usual (TAU) (Behavioral)
结局指标
主要结局
Use of intervention as measured by information provided by the Brainer Learning Management System (LMS)
时间窗: 1 month, 3 months
The LMS provides data on which components of the SAFETY-P modules were accessed, completion or non-completion of the component module, at which point in the content does discontinuation occur, time spent using the modules.
Intervention feasibility and acceptability on the SAFETY-P Satisfaction Scale
时间窗: 1 month, 3 months
The SAFETY-P Satisfaction Scale consists of 8 items and measures acceptability of the SAFETY-P tool.
Satisfaction with intervention on the Peabody Treatment Progress Battery (PTPB) - Service Satisfaction Scale (SSS)
时间窗: 1 month, 3 months
The PTPB is an integrated set of brief, reliable, and valid instruments that can be administered efficiently at low cost and can provide systematic feedback for use in treatment planning. It includes eleven measures completed by youth, caregivers, and/or clinicians that assess clinically-relevant constructs such as symptom severity, therapeutic alliance, life satisfaction, motivation for treatment, hope, treatment expectations, caregiver strain, and service satisfaction. The SSS provides a general indicator of how well youth and adult caregivers perceive the mental health organization's services.
Intervention usability on the System Usability Scale
时间窗: 1 month
The System Usability Scale consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. The scale evaluates a wide variety of products and services, including hardware, software, mobile devices, websites and applications.
Intervention acceptability on the Mobile Application Rating Scale: User Version (uMARS)
时间窗: 1 Month
The uMARS is a simple tool that can be reliably used by end-users to assess the quality of mHealth apps. The uMARS provides a 20-item measure that includes 4 objective quality subscales-engagement, functionality, aesthetics, and information quality-and 1 subjective quality subscale.
Utilization of mental health services on the Child and Adolescent Services Assessment: Brief and Adapted version (CASA)
时间窗: Baseline, 1 month, 3 months
The CASA is a self and parent report instrument designed to assess the use of mental health services by children aged 8-18 yrs. The CASA includes 31 settings covering inpatient, outpatient, and informal services provided by a variety of child serving providers and sectors. It collects information on whether a service was ever used and more detailed information (length of stay/number of visits, focus of treatment) on services used in the recent past.
次要结局
- Youth psychopathology as measured by the Youth Self-Report (YSR)(Baseline)
- Change from baseline in depressive symptoms for youth and parent participants on the Center for Epidemiological Studies Depression Scale (CES-D) at 1 month and 3 months(Baseline, 1 month, 3 months)
- Change from baseline in suicidal ideation severity on the Suicidal Ideation Questionnaire-Junior (SIQ-JR) at 1 month and 3 months(Baseline, 1 month, 3 months)
- Change from baseline in parent emotional dysregulation on the Difficulties in Emotion Regulation Scale (DERS) at 1 month and 3 months(Baseline, 1 month, 3 months)
- Youth psychopathology as measured by the Child Behavior Checklist (CBCL)(Baseline)
- Parent psychopathology as measured by the Brief Symptom Inventory (BSI)(Baseline)
- Change from baseline in suicidal ideation and behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) at 30 days and 3 months(Baseline, 1 month, 3 months)
- Change from baseline in family conflict measures on the Conflict Behavior Questionnaire (CBQ) at 1 month and 3 months(Baseline, 1 month, 3 months)
- Change from baseline in feelings of which measures thwarted belongingness and perceived burdensomeness for youth participants on the Interpersonal Needs Questionnaire-Adolescent Version (INQ) at 1 month and 3 months(Baseline, 1 month, 3 months)
- Change from baseline in parent distress related to caring for a child with mental illness on the Caregiver Strain Questionnaire at 1 month and 3 months(Baseline, 1 month, 3 months)
- Change from baseline in parental confidence in their ability to prevent or manage a suicidal crisis on the Parent Self-Efficacy for Suicide and the Self-Assessed Expectations of Suicide Risk Scale, Adapted for Parents at 1 month and 3 months(Baseline, 1 month, 3 months)
研究者
Jennifer Hughes
Psychologist & Clinical Scholar, Associate Professor
Nationwide Children's Hospital