Viewing Study NCT04797455



Ignite Creation Date: 2024-05-06 @ 3:53 PM
Last Modification Date: 2024-10-26 @ 1:59 PM
Study NCT ID: NCT04797455
Status: RECRUITING
Last Update Posted: 2023-05-10
First Post: 2021-03-07

Brief Title: Parent Intervention for Psychiatrically-Hospitalized Youth
Sponsor: Stanford University
Organization: Stanford University

Study Overview

Official Title: Pilot Intervention for Parents of Psychiatrically-Hospitalized Youth
Status: RECRUITING
Status Verified Date: 2023-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of the present study is to conduct a pilot randomized clinical trial RCT of a parent coaching intervention for parents of youth hospitalized for suicidal ideation suicide attempts or non-suicidal self-injury Parents will receive either the parent coaching intervention which includes safety planning and behavioral parenting skills training with a clinician and assistance with linkage to follow-up care by a case manager or treatment as usual TAU for the inpatient unit The long-term goal of the research is to determine if augmenting standard inpatient treatment with additional parenting intervention improves youth treatment response on suicide-related outcomes ie suicidal ideation non-suicidal self-injury and suicide attempts The goal of this pilot RCT is to collect preliminary data needed for a larger RCT including feasibility acceptability safety tolerability engagement of the presumed mechanism of change changes in parent emotions and behaviors and signal detection of any changes in youth suicide-related outcomes
Detailed Description: The present study is a pilot parent coaching intervention PI The investigators will enroll N 40 pairs of youth and parents enrolled in an adolescent psychiatric inpatient program This program called the Stanford at Mills-Peninsula Hospital STAM is jointly run by Stanford and Mills-Peninsula Hospital All research procedures will be conducted by Stanford faculty and staff Parents and youth who provide informed consent will be randomly assigned to receive the PI standard Inpatient treatment or standard inpatient treatment only Parents assigned to the PI inpatient treatment will be offered 4 sessions of DBT-based parenting interventions which include safety planning behavioral parenting interventions and support for care linkage Youth will participate in study assessments only and will not receive additional treatment as part of the study ie they will receive treatment as usual Study participation is optional and will not impact the familys ability to participate in the inpatient treatment Youth will stay admitted to the inpatient program as part of standard clinical practices regardless of whether or not they choose to participate in the study Assessments will be conducted at baseline 3-month follow-up 6 month follow-up and 12-month follow-up Both parents will be encouraged to take part in the intervention however the participation of only one parent will be required The intervention will consist of 4 individual parent sessions to be completed within one month of youth discharge from the hospital or of care linkage whichever coms first Sessions will be 60 to 90 minutes in length and will be offered weekly Therapists may see parents more than once a week if needed as long as the total number of sessions does not exceed 4 Sessions will focus on safety planning and care linkage Parent skills building parent conflict resolution and parent self-care using adolescent DBT handouts

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None