Integrated Intervention for Caregivers--Pilot RCT

NCT ID: NCT03487627

Last Updated: 2022-12-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-04
• Study Completion Date: 2022-12-14

Brief Summary

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.

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.

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.

Conditions

Distress; Maternal; Self Efficacy; Parenting; Suicide

Keywords

adolescent; parental support; parental coping

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Electronic and Care Support Manager Contact

Participants receive electronic content and contact with a Care Support Manager

Group Type: EXPERIMENTAL

Electronic and Care Support Manager Contact

Intervention Type: BEHAVIORAL

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.

Enhanced treatment-as-usual (TAU)

Participants receive enhanced treatment-as-usual

Group Type: ACTIVE_COMPARATOR

Enhanced Treatment-as-usual (TAU)

Intervention Type: BEHAVIORAL

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.

Interventions

Electronic and Care Support Manager Contact

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.

Intervention Type: BEHAVIORAL

Enhanced Treatment-as-usual (TAU)

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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, investigators will ask parents 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

Duke University

OTHER

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephanie S Daniel, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00055566-PRCT

Identifier Type: -

Identifier Source: org_study_id