Integrated Intervention for Caregivers--Pilot RCT

NCT03487627 | Completed DMC

• 1 other identifier: IRB00055566-PRCT
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Distress; Maternal; Self Efficacy; Parenting; Suicide

Keywords

adolescent; parental support; parental coping

Outcome Measures

Primary Outcomes (6)

• Change in parental distress as assessed with SCL-90-R

  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.

  Baseline (hospitalization), and at 3- and 6- months following discharge

• Change in parental self-efficacy as assessed with PSOC

  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.

  Baseline (hospitalization), and at 3- and 6- months following discharge

• Change in parental self-efficacy as assessed with "Me as a Parent" Parent Self-Regulation scale

  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.

  Baseline (hospitalization), and at 3- and 6- months following discharge

• Change in parenting practices as assessed with Alabama Parenting Practices Questionnaire

  The Alabama Parenting Practices Questionnaire will be used to assess parenting behaviors. For purposes of our study, investigators 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.

  Baseline (hospitalization), and at 3- and 6- months following discharge

• Change in parent reports of adolescent suicidal behavior as assessed with C-SSRS

  Parental 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.

  Baseline (hospitalization), and at 3- and 6- months following discharge

• Change in child emotional and behavioral problems as assessed with CBCL

  To provide some contextual information at each assessment, parents 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.

  Baseline (hospitalization), and at 3- and 6- months following discharge

Secondary Outcomes (4)

• Change in parent perceptions of support and safety monitoring as assessed with a series of likert rating questions

  Through study completion, up to 6 months following discharge

• Adolescent service use assessed with CASA and treatment records

  Baseline (hospitalization), and at 3- and 6- months following discharge

• Cost information assessed with measure of time spent

  Up to 6 months following discharge

• Assessment of the patient satisfaction and acceptability of the intervention assessed with the Client Satisfaction Questionnaire

  Through study completion, up to 6 months following discharge

Study Arms (2)

Electronic and Care Support Manager Contact

EXPERIMENTAL

Participants receive electronic content and contact with a Care Support Manager

Behavioral: Electronic and Care Support Manager Contact

Enhanced treatment-as-usual (TAU)

ACTIVE COMPARATOR

Participants receive enhanced treatment-as-usual

Behavioral: Enhanced Treatment-as-usual (TAU)

Interventions

Electronic and Care Support Manager Contact 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.

Electronic and Care Support Manager Contact

Enhanced Treatment-as-usual (TAU) 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.

Enhanced treatment-as-usual (TAU)

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Duke University: collaborator
• University of Rochester: collaborator

Study Sites (1)

Wake Forest Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Stephanie S Daniel, Ph.D.

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2018
• First Posted: April 4, 2018
• Study Start: May 4, 2021
• Primary Completion: December 14, 2022
• Study Completion: December 14, 2022
• Last Updated: December 30, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Investigators will begin uploading raw data to the NDCT system semiannually (January 15, July 15) after data collection has begun. All data will be shared prior to the end of the grant.
• Access Criteria: Data will be shared with researchers who have access to the National Database for Clinical Trials related to Mental Illness (NDCT).

Locations

US (1)