- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03487575
Integrated Intervention for Caregivers--Open Trial
Integrated Electronic and Care Manager Support Intervention For Caregivers of Adolescents With Suicidal Behavior--Open Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
In the context of an open trial, the primary aim is to assess the feasibility of this intervention, and to use experiences from implementing the intervention and feedback from caregivers and care support managers to refine the intervention.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Biological, adoptive, or step-parent (step-parent defined as by marriage or live-in partner of at least 5 years) of an adolescent. If an adolescent has more than one parent, parents will be asked to designate the primary contact or participant for this study (only one parent for an adolescent may participate).
- The adolescent is 13-19 years of age
- The adolescent was psychiatrically hospitalized due to any range of suicidal behaviors (i.e., suicide attempt, interrupted suicide attempt, aborted suicide attempt) in the last two weeks
- The parent lives with the adolescent
- The parent has a cell phone and is capable of texting (i.e., has knowledge of how to text and has a data plan that allows for texting)
Exclusion Criteria:
- Parents whose primary language is not English and are unable to read or speak English, as all materials will be initially developed in English only
- Parents who have a reported intellectual disability (per inpatient staff)
- Parents whose adolescent is not discharged directly home (e.g., adolescent is sent to a group home, residential treatment facility, or home of a relative following hospitalization)
- Adolescents who have an intellectual disability (per inpatient staff or as reflected by current school placement) or have active psychosis, as the needs of both parent and youth may be different than those without an intellectual disability or active psychosis and are not specifically addressed in the proposed developing intervention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Open trial
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Integrated electronic support and care support manager contact
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in parental distress as assessed with SCL-90-R
Time Frame: Baseline (hospitalization), and at 3- and 6- months following discharge
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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.
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Baseline (hospitalization), and at 3- and 6- months following discharge
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Change in parental self-efficacy as assessed with PSOC
Time Frame: Baseline (hospitalization), and at 3- and 6- months following discharge
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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.
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Baseline (hospitalization), and at 3- and 6- months following discharge
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Change in parental self-efficacy as assessed with "Me as a Parent" Parent Self-Regulation scale
Time Frame: Baseline (hospitalization), and at 3- and 6- months following discharge
|
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.
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Baseline (hospitalization), and at 3- and 6- months following discharge
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Change in parenting practices as assessed with Alabama Parenting Practices Questionnaire
Time Frame: Baseline (hospitalization), and at 3- and 6- months following discharge
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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.
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Baseline (hospitalization), and at 3- and 6- months following discharge
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Change in parent reports of adolescent suicidal behavior as assessed with C-SSRS
Time Frame: Baseline (hospitalization), and at 3- and 6- months following discharge
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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.
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Baseline (hospitalization), and at 3- and 6- months following discharge
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Change in child emotional and behavioral problems as assessed with CBCL
Time Frame: Baseline (hospitalization), and at 3- and 6- months following discharge
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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.
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Baseline (hospitalization), and at 3- and 6- months following discharge
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in parent perceptions of support and safety monitoring as assessed with a series of likert rating questions
Time Frame: Through study completion, up to 6 months following discharge
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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.
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Through study completion, up to 6 months following discharge
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Adolescent service use assessed with CASA and treatment records
Time Frame: Baseline (hospitalization), and at 3- and 6- months following discharge
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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.
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Baseline (hospitalization), and at 3- and 6- months following discharge
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Cost information assessed with measure of time spent
Time Frame: Up to 6 months following discharge
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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.
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Up to 6 months following discharge
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Assessment of the patient satisfaction and acceptability of the intervention assessed with Client Satisfaction Questionnaire
Time Frame: Through study completion, up to 6 months following discharge
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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.
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Through study completion, up to 6 months following discharge
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Collaborators and Investigators
Investigators
- Principal Investigator: Stephanie S Daniel, Ph.D., Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00055566-OT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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