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Integrated Intervention for Caregivers--Open Trial

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ClinicalTrials.gov Identifier: NCT03487575
Recruitment Status : Not yet recruiting
First Posted : April 4, 2018
Last Update Posted : April 5, 2018
Sponsor:
Collaborators:
Duke University
University of Rochester
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
Adolescents who have been hospitalized after attempting suicide 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 these efforts by parents, adolescents often have additional crisis situations. The goal of this study is to develop and test an integrated electronic (mHealth) and care support service intervention for 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 open trial will assess the feasibility of this intervention for a separate pilot randomized controlled trial to compare the intervention to enhanced treatment as usual.

Condition or disease Intervention/treatment Phase
Distress; Maternal Self-Efficacy Parenting Suicide Behavioral: Open trial Not Applicable

Detailed Description:

Adolescents who have been hospitalized after attempting suicide 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 (mHealth) and care support service intervention for caregivers of adolescents who have made a recent suicide attempt. 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 : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Integrated Electronic and Care Manager Support Intervention For Caregivers of Adolescents With Suicide Attempts--Open Trial
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Suicide

Arm Intervention/treatment
Experimental: Open trial Behavioral: Open trial
Integrated mHealth and support care managers




Primary Outcome Measures :
  1. Change in parental distress as assessed with SCL-90-R [ Time Frame: Baseline (hospitalization), and at 3- and 6- months following discharge ]
    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.

  2. Change in parental self-efficacy as assessed with PSOC [ Time Frame: Baseline (hospitalization), and at 3- and 6- months following discharge ]
    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.

  3. 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.

  4. Change in parenting practices as assessed with Alabama Parenting Practices Questionnaire [ Time Frame: Baseline (hospitalization), and at 3- and 6- months following discharge ]
    The Alabama Parenting Practices Questionnaire will be used to assess parenting behaviors. For purposes of our study, we 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.

  5. 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 ]
    Maternal 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.

  6. Change in child emotional and behavioral problems as assessed with CBCL [ Time Frame: Baseline (hospitalization), and at 3- and 6- months following discharge ]
    To provide some contextual information at each assessment, mothers 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.


Secondary Outcome Measures :
  1. 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 ]
    Using a series of likert rating questions, we also will assess the degree to which parents feel they were provided with information regarding their child's condition and the management of their child in the home, and the degree to which they feel supported by the intervention and by mental health professionals. We 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 CSM will use ratings during their regular check-ins to gauge the degree to which mothers' needs are being met.

  2. Adolescent service use assessed with CASA and treatment records [ Time Frame: Baseline (hospitalization), and at 3- and 6- months following discharge ]
    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, we will obtain adolescents' treatment records to verify contacts with mental health providers. This measure does not have an overall scale range.

  3. Cost information assessed with measure of time spent [ Time Frame: Up to 6 months following discharge ]
    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.

  4. 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 ]
    To assess patient satisfaction and acceptability of the intervention, we 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 mothers use the mHealth application over time.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biological mother, adoptive mother, stepmother, or legal guardian of an adolescent
  • 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 mother/guardian lives with the adolescent
  • The mother/guardian 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:

  • Mothers/guardians whose primary language is not English and are unable to read or speak English, as all materials will be initially developed in English only
  • Mothers/guardians who have a reported intellectual disability (per inpatient staff)
  • Mothers/guardians whose adolescent is not discharged directly home (e.g., adolescent is sent to a group home, residential treatment facility, or a relative's home 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 mother and youth may be different than those without an intellectual disability or active psychosis and are not specifically addressed in the proposed developing intervention

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03487575


Contacts
Contact: Stephanie S Daniel, Ph.D. 336-716-1839 sdaniel@wakehealth.edu
Contact: Andy M Mayfield, MMFT 336-716-6815 amayfiel@wakehealth.edu

Locations
United States, North Carolina
Wake Forest School of Medicine Not yet recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Stephanie S Daniel, Ph.D.    336-716-1839    sdaniel@wakehealth.edu   
Contact: Andy Mayfield, MMFT    336-716-6815    amayfiel@wakehealth.edu   
Principal Investigator: Stephanie S Daniel, Ph.D.         
Sponsors and Collaborators
Wake Forest University Health Sciences
Duke University
University of Rochester
Investigators
Principal Investigator: Stephanie S Daniel, Ph.D. Wake Forest University Health Sciences

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03487575     History of Changes
Other Study ID Numbers: IRB00049218-OT
First Posted: April 4, 2018    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:
Adolescent
Parental Support
Parental Coping

Additional relevant MeSH terms:
Suicide
Self-Injurious Behavior
Behavioral Symptoms