Clinical trial NCT03487627: Integrated Intervention for Caregivers--Pilot RCT
Official title: Integrated Electronic and Care Manager Support Intervention For Caregivers of Adolescents With Suicidal Behavior--Pilot RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distress; Maternal
Self Efficacy
Parenting
Suicide
Keywords: adolescent
parental support
parental coping
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Duke University
name: University of Rochester
First posted: 2018-04-04
Enrollment: 90
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in parental distress as assessed with SCL-90-R
timeFrame: Baseline (hospitalization), and at 3- and 6- months following discharge
measure: Change in parental self-efficacy as assessed with PSOC
timeFrame: Baseline (hospitalization), and at 3- and 6- months following discharge
measure: Change in parental self-efficacy as assessed with "Me as a Parent" Parent Self-Regulation scale
timeFrame: Baseline (hospitalization), and at 3- and 6- months following discharge
measure: Change in parenting practices as assessed with Alabama Parenting Practices Questionnaire
timeFrame: Baseline (hospitalization), and at 3- and 6- months following discharge
measure: Change in parent reports of adolescent suicidal behavior as assessed with C-SSRS
timeFrame: Baseline (hospitalization), and at 3- and 6- months following discharge
measure: Change in child emotional and behavioral problems as assessed with CBCL
timeFrame: Baseline (hospitalization), and at 3- and 6- months following discharge
Secondary outcomes:
measure: Change in parent perceptions of support and safety monitoring as assessed with a series of likert rating questions
timeFrame: Through study completion, up to 6 months following discharge
measure: Adolescent service use assessed with CASA and treatment records
timeFrame: Baseline (hospitalization), and at 3- and 6- months following discharge
measure: Cost information assessed with measure of time spent
timeFrame: Up to 6 months following discharge
measure: Assessment of the patient satisfaction and acceptability of the intervention assessed with the Client Satisfaction Questionnaire
timeFrame: Through study completion, up to 6 months following discharge
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Stephanie S Daniel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: