SAFETY-Parent: Online Learning Module to Support Parents of Suicidal Youth
NCT Number: NCT06460220
Acronym: SAFETY-P
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Suicide|Suicide, Attempted|Suicide and Self-harm|Suicide Threat
Interventions: BEHAVIORAL: Safe Alternatives for Teens and Youth - Parent (SAFETY-P)|BEHAVIORAL: Treatment As Usual (TAU)
Sponsor: Jennifer Hughes
Collaborators: American Foundation for Suicide Prevention
Sex: ALL
Age: CHILD, ADULT
Enrollment: 65
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-10
Completion Date: 2025-12
Locations: Nationwide Children's Hospital, Columbus, Ohio, 43205, United States|Nationwide Children's Hospital, Columbus, Ohio, 43215, United States

Summary:
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).

Primary Outcome Measures: Satisfaction with intervention on the Peabody Treatment Progress Battery (PTPB) - Service Satisfaction Scale (SSS), 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., 1 month, 3 months|Use of intervention as measured by information provided by the Brainer Learning Management System (LMS), 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., 1 month, 3 months|Intervention feasibility and acceptability on the SAFETY-P Satisfaction Scale, The SAFETY-P Satisfaction Scale consists of 8 items and measures acceptability of the SAFETY-P tool., 1 month, 3 months|Intervention usability on the System Usability Scale, 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., 1 month|Intervention acceptability on the Mobile Application Rating Scale: User Version (uMARS), 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., 1 Month|Utilization of mental health services on the Child and Adolescent Services Assessment: Brief and Adapted version (CASA), 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., Baseline, 1 month, 3 months
Secondary Outcome Measures: Change from baseline in suicidal ideation and behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) at 30 days and 3 months, The C-SSRS is a validated, semi-structured interview that assesses both suicidal behavior and suicidal ideation (yes/no, frequency), with flexible time points and multiple informants depending on administrator purpose and need., 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, The SIQ-JR is a 15-item modified version of the 30-item Suicidal Ideation Questionnaire. The SIQ-JR is a validated self-report measure of suicidal ideation severity in adolescents (7-point scale; 0="I never had this thought"; 6="Almost every day")., Baseline, 1 month, 3 months|Youth psychopathology as measured by the Child Behavior Checklist (CBCL), The CBCL is a standardized measure based on new national norms that were collected February 1999-January 2000. The CBCL is to be completed by the parent/caretaker who spends the most time with the child. The CBCL provides ratings for 20 competence and 120 problem items. The CBCL includes open-ended items covering physical problems, concerns, and strengths. Parents rate how true each item is now, or was within the past 6 months. The CBCL yields scores on internalizing, externalizing, and total problems as well as scores on DSM-IV related scales., Baseline|Youth psychopathology as measured by the Youth Self-Report (YSR), The Youth Self-Report (YSR) is a widely used child-report measure that assesses problem behaviors along two "broadband scales": Internalizing and Externalizing. It also scores eight empirically based syndromes and DSM-oriented scales, and provides a summary of Total Problems. The measure assesses "Total Competency," which is a scale comprised of competency in activities, social functioning, and school performance., 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, The CES-D is a 20-item measure that asks caregivers to rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms., 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, The INQ-15 (19) is a self-report measure composed of 15 items that evaluate the main constructs of interpersonal suicide theory (8): perceived burdensomeness and thwarted belongingness. The items are answered on a 1-7 Likert scale (1 = Not at all true for me, 4 = Somewhat true for me, 7 = Very true for me)., 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, The DERS is a brief, 36-item, self-report questionnaire designed to assess multiple aspects of emotion dysregulation. The measure yields a total score as well as scores on six scales derived through factor analysis., Baseline, 1 month, 3 months|Parent psychopathology as measured by the Brief Symptom Inventory (BSI), The BSI is a 53-item self-report inventory in which participants rate the extent to which they have been bothered (0 ="not at all" to 4="extremely") in the past week by various symptoms. The BSI has nine subscales designed to assess individual symptom groups: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism. The BSI also includes three scales that capture global psychological distress., Baseline|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, The Caregiver Strain Questionnaire is a 21-item measure of self-reported strain experienced by caregivers and families of youth with emotional problems, with responses on a 5-point Likert scale (0 = Not at all, 4 = very much). It assesses the demands, responsibilities, difficulties, and negative psychological consequences of caring for children and adolescents with emotional and behavioral disorders., 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, The Parent Self-Efficacy for Suicide and the Self-Assessed Expectations of Suicide Risk Scale is a 12 item measure using a 10-point Likert scale (0=not at all confident, 5=somewhat confident, 10=completely confident). It measures parental confidence in caring for an adolescent experiencing suicidal ideation., Baseline, 1 month, 3 months|Change from baseline in family conflict measures on the Conflict Behavior Questionnaire (CBQ) at 1 month and 3 months, The Conflict Behavior Questionnaire (CBQ) is designed to obtain evaluations of parent and adolescent behavior directly from parent and adolescent. The questionnaire reliably measures whether or not a family is experiencing distress., Baseline, 1 month, 3 months