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Integrated Intervention for Caregivers--Open Trial

NCT ID: NCT03487575

Last Updated: 2021-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-12

Study Completion Date

2021-08-19

Brief Summary

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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 these efforts 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 parents 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.

Detailed Description

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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.

Conditions

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Distress; Maternal Self-Efficacy Parenting Suicide

Keywords

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Adolescent Parental Support Parental Coping

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Open trial

Group Type EXPERIMENTAL

Open trial

Intervention Type BEHAVIORAL

Integrated electronic support and care support manager contact

Interventions

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Open trial

Integrated electronic support and care support manager contact

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephanie S Daniel, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest School of Medicine

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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IRB00055566-OT

Identifier Type: -

Identifier Source: org_study_id