Integrated Intervention for Caregivers--Pilot RCT

NCT03487627 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2022-12-30

No results posted yet for this study

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.

Conditions

  • Distress; Maternal
  • Self Efficacy
  • Parenting
  • Suicide

Interventions

BEHAVIORAL

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.

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.

Sponsors & Collaborators

  • Duke University

    collaborator OTHER
  • University of Rochester

    collaborator OTHER
  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Stephanie S Daniel, Ph.D. · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-04
Primary Completion
2022-12-14
Completion
2022-12-14

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03487627 on ClinicalTrials.gov