An interventional study of Electronic and Care Support Manager Contact and Enhanced Treatment-as-usual (TAU) in Distress; Maternal, Self Efficacy and Parenting, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2022-12-30.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Supportive care
Among 386 studies in Suicide with a site in United States — 99 open to participants now, 113 under way, 2 of them phase 3. Suicide · United States.
Among the 386 studies in Suicide with a site in United States, this one is the 176th largest by enrollment of the 348 interventional ones, is one of 32 that started in 2021, is one of 288 with no phase, and was the 132nd registered.
607 studies on the registry are indexed under Suicide; 162 are open to participants now.
This study's enrollment of 90 is below the median of 104 across 490 interventional studies indexed under Suicide.
Browse Suicide studies →99 of the 386 studies in Suicide with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 114 Suicide studies recruiting now, 54 (47%) set no upper age limit and 57 (50%) stop at 75 or younger; 52 take children under 18; 24 take healthy volunteers.
This study: 13 Years and older · all sexes · no healthy volunteers.
The full table on the hub →386 studies; the count open now beside each. This study's row is marked.
First in 1990; this study’s year is marked. 32 started in 2021.
Median enrollment 91 across the 348 interventional studies, 172 across the 36 observational. Of the 251 that completed or were terminated, 103 (41%) have results posted.
15 of 386 have an industry lead sponsor. The 10 most frequent:
Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
Wake Forest University Health Sciences has 3 studies filed under Suicide — fewer than ten, so there is no comparison to draw.
43 of the studies in Suicide with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05696691Phase 3The University of Texas Health Science Center at San AntonioKetamine & Crisis Response Plan for Suicidal Ideation in the ED | 2026-12-31 |
| NCT05558332University of California, IrvineYouth Nominated Support Team | 2026-11 |
| NCT06470867VA Office of Research and DevelopmentRandomized Controlled Effectiveness Trial of VA S.A.V.E. | 2026-11-27 |
| NCT05897164Evidence-Based Practice Institute, Seattle, WAMobile Technology to Reduce Teen Substance Misuse | 2026-11-30 |
| NCT06460220Jennifer HughesSAFETY-Parent: Online Learning Module to Support Parents of Suicidal Youth | 2026-12 |
Among the 386 studies in Suicide with a site in United States, from their registry updates:
Adolescents who have been hospitalized for suicidal behavior are at risk for engaging in additional suicidal behavior. After hospitalization, parents or guardians are typically asked to be responsible for helping to prevent further suicidal behavior. This can include monitoring the youth, making sure the home is safe, getting the youth any needed treatment, and balancing the parents' expectations of the youth with the understanding that the youth is in a vulnerable state. Even with this effort by parents, adolescents often have additional crisis situations. The goal of this study is to develop and test an integrated electronic and care support service intervention for these caregivers of suicidal youth. It is expected that this intervention will help parents/guardians in the roles of caring for suicidal youth after discharge from the hospital. This pilot randomized controlled trial will compare the intervention to enhanced treatment as usual.
Adolescents who have been hospitalized for suicidal behavior are at high risk for engaging in additional suicidal behavior. Following hospitalization, parents or guardians are typically tasked with helping to prevent further suicidal episodes by monitoring youth, ensuring safety in the home, helping youth receive needed care, and parenting in a way that balances expectations for appropriate behavior with recognition of the vulnerable status of the adolescents. Despite parental efforts, adolescents often have additional crises, which sometimes culminate in emergency department visits and repeat hospitalizations. Findings from the principal investigators' recent longitudinal study of mothers after adolescent hospitalization for suicide attempts (Impact of Adolescent Hospitalization on Parents) suggested that the period of time following discharge from the hospital can be a very important time for providing services and supports to youth and families. Parents in that study described emotional distress (e.g., depression, anxiety) and reduced parenting self-efficacy, and indicated a need for more information about suicidal youth and the treatment needs of these youth, parenting and monitoring of suicidal youth, and support in navigating the treatment system.
Given these needs, the purpose of this study is to develop, refine, and preliminarily test an integrated electronic and care support service intervention for caregivers of adolescents who have recently engaged in suicidal behavior. It is expected that such an intervention will provide needed information and supports to parents, increase parenting self-efficacy, increase parents' ability to follow safety plans in the home, reduce parents' emotional distress, and help parents access needed services in the community. As a consequence of these proximal outcomes, it is expected that the intervention will help facilitate treatment engagement and follow through for youth and caregiver, and reduce use of emergency mental health services and hospitalizations.
The primary aim is to obtain, in a pilot randomized controlled trial, preliminary estimates of treatment effectiveness relative to enhanced treatment as usual. The proposed adaptive services intervention development research is intended to demonstrate the feasibility and potential utility of an intervention that will be embedded in the existing care system (psychiatric inpatient unit) for suicidal youth and the families of these youth, and ultimately, improve engagement in services and client outcomes in high-risk families.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants receive electronic content and contact with a Care Support Manager
Behavioral: Electronic and Care Support Manager Contact
Participants receive enhanced treatment-as-usual
Behavioral: Enhanced Treatment-as-usual (TAU)
This intervention will consist of electronic and Care Support Manager (CSM) contacts with parents from the first week following their adolescent's discharge from hospitalization through the first 3 months after discharge. The electronic application content will be accessible and delivered to parents weekly. Parents will also be able to enter a keyword on their electronic device to access content and material in real time. The CSM contacts will supplement the informational content delivered electronically by providing opportunities to ask questions about the electronic application material, and by checking on progress toward treatment follow through for their youth, identifying and problem solving any difficulties and concerns, and addressing health needs of each parent.
TAU typically involves a discharge planning session by unit staff with the adolescent and their parent(s) to discuss safety monitoring and referrals for mental health services following discharge from psychiatric hospitalization. Investigators will augment this usual care by providing written materials to families outlining some of the key considerations for caring for their adolescent. These written materials will include brochures with information for parents following adolescent suicidal behavior, a listing of resources including instructions for when to call 911 or go to the emergency room, and information regarding the National Suicide Prevention Lifeline. Written materials will be provided to both the enhanced TAU participants as well as participants receiving the electronic and CSM intervention.
Change in parental distress as assessed with SCL-90-R
To assess severity of depression, anxiety, and hostility, parents will be administered the Symptom Checklist - 90 (SCL-90-R). The SCL-90-R yields scores along several dimensions: Somatization, Obsessive-Compulsive, Interpersonal Sensitivity, Depression, Anxiety, Hostility, Phobic Anxiety, Paranoid Ideation, and Psychoticism. The scale range for each dimension is a T-score of 0-100, with higher scores representing greater problem severity.
Time frame: Baseline (hospitalization), and at 3- and 6- months following discharge
Change in parental self-efficacy as assessed with PSOC
Facets of parental self-efficacy will be assessed with the Parenting Sense of Competence Scale (PSOC), which measures sense of self-efficacy and satisfaction with parenting. It has a scale range of 17-102, with higher scores indicating a greater parenting sense of competency. It has been used with parents of children and adolescents.
Time frame: Baseline (hospitalization), and at 3- and 6- months following discharge
Change in parental self-efficacy as assessed with "Me as a Parent" Parent Self-Regulation scale
Facets of parental self-efficacy will be assessed with the "Me as a Parent" Parenting Self-Regulation scale, which assesses constructs such as sense of effectiveness, sense of control as a parent, ability to manage situations with children (a central concept for the current study), and parental self-management (planful parenting activities). The scale range is 16 - 80, with higher scores representing a greater parental sense of self-regulation. It has been used with parents of children and adolescents.
Time frame: Baseline (hospitalization), and at 3- and 6- months following discharge
Change in parenting practices as assessed with Alabama Parenting Practices Questionnaire
The Alabama Parenting Practices Questionnaire will be used to assess parenting behaviors. For purposes of our study, investigators will focus on the parental involvement subscale (10 items), the positive parenting subscale (6 items), the monitoring and supervision subscale (10 items), and the inconsistent discipline scale (6 items). The scale ranges are 10-50 for the 10-item subscales, and 6-30 for the 6-item subscales. Higher scores denote better outcomes for the parental involvement and positive parenting subscales, whereas higher scores denote worse outcomes for the monitoring/supervision and inconsistent discipline subscales.
Time frame: Baseline (hospitalization), and at 3- and 6- months following discharge
Change in parent reports of adolescent suicidal behavior as assessed with C-SSRS
Parental reports of adolescent suicidal ideation and behaviors following hospitalization will be assessed with selected queries from the Columbia - Suicide Severity Rating Scale (C-SSRS). This measure does not have an overall scoring range, but it does include a suicidal ideation intensity rating with a range 0-25. In general, a greater number of endorsed items and/or a higher suicidal ideation intensity rating denote greater suicidal risk.
Time frame: Baseline (hospitalization), and at 3- and 6- months following discharge
Change in child emotional and behavioral problems as assessed with CBCL
To provide some contextual information at each assessment, parents at baseline hospitalization only will complete the Achenbach Child Behavior Checklist (CBCL). The CBCL is a widely used parent-report scale. The measure includes 20 subscales, each having a T-score range of 50-100, with higher scores denoting greater psychological and behavioral problems.
Time frame: Baseline (hospitalization), and at 3- and 6- months following discharge
Change in parent perceptions of support and safety monitoring as assessed with a series of likert rating questions
Using a series of likert rating questions, investigators also will assess the degree to which parents feel provided with information regarding their child's condition and the management of their child in the home, and the degree to which parents feel supported by the intervention and by mental health professionals. Investigators will use likert scales at formal assessment points to assess perceived success and confidence in monitoring youth and following safety plans in the first month after hospitalization, and during any other times of high risk. In addition to formal assessments, the care support manager will use ratings during regular check-ins to gauge the degree to which parents' needs are being met.
Time frame: Through study completion, up to 6 months following discharge
Adolescent service use assessed with CASA and treatment records
The semi-structured interview-based Child and Adolescent Services Assessment-Parent Interview-Version 5.0 (CASA) will be used to assess emergency department visits and repeat hospitalizations; duration and frequency of adolescent involvement with specialty mental health services (therapists, psychiatrists, etc.) following hospitalization; and attitudes about service use for adolescents. In addition, with consent/assent of parents and adolescents, investigators will obtain adolescents' treatment records to verify contacts with mental health providers. This measure does not have an overall scale range.
Time frame: Baseline (hospitalization), and at 3- and 6- months following discharge
Cost information assessed with measure of time spent
Time spent by the care support manager in patient contacts, preparation, and documentation will be tracked to estimate potential costs. These data will be preliminary due to the early phase of intervention development, but will set the stage for scalability efforts and later well-powered cost-effectiveness studies.
Time frame: Up to 6 months following discharge
Assessment of the patient satisfaction and acceptability of the intervention assessed with the Client Satisfaction Questionnaire
To assess patient satisfaction and acceptability of the intervention, investigators will administer the Client Satisfaction Questionnaire. This measure has a range of 8-32, with higher scores indicating greater satisfaction. Following Mohr et al. (2011), additional indices of the acceptability and usability of the intervention will include the degree to which parents use the mHealth application over time.
Time frame: Through study completion, up to 6 months following discharge
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — In order to adhere to the goal of data sharing among researchers, investigators will share data from this study via the National Database for Clinical Trials related to Mental Illness (NDCT). Based on the procedures outlined on the NDCT web site, investigators will collect information necessary to generate a Global Unique Identifier (GUID), a universal subject identifier, for each participant. No personal identifying information, nor data that could be used deductively to identify participants, however, will be shared with other researchers, particularly given the relatively small size of the data set. The GUID will allow sharing of information across research studies. Research participants will be informed of the Resource Sharing Plan in the consent forms for participation in the studies, using text similar to the example plain language text for informed consent forms provided by the NDCT.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Investigators will begin uploading raw data to the NDCT system semiannually (January 15, July 15) after data collection has begun. All data will be shared prior to the end of the grant.
Access criteria: Data will be shared with researchers who have access to the National Database for Clinical Trials related to Mental Illness (NDCT).
Ran from May 2021 to primary completion in Dec 2022, 19 months.
Of 308 non-industry interventional studies with no phase under Suicide, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 54. This study's 19 months is below that.
Counting every sponsor, half of 319 studies reached it within 30 months; a quarter within 15 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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