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Parent Intervention for Psychiatrically-Hospitalized Youth

Primary Purpose

Adolescent - Emotional Problem, Suicide and Self-harm, Parenting

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DBT-Based Parenting Intervention
Treatment as usual
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adolescent - Emotional Problem focused on measuring suicide, Self-Injurious Behavior, Behavioral Symptoms

Eligibility Criteria

12 Years - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria are:

  • youth is currently hospitalized on the Stanford unit at Mills Peninsula Medical Center, on the Inpatient Adolescent Psychiatry Unit, for suicidal ideation, suicide attempt(s), or non-suicidal self-injury)
  • youth is between the ages of 12-18 (18 year-old youth must still be in high school and living at home with parents for the duration of the study)
  • at least one parent/guardian is willing to participate in the study intervention
  • youth and parent speak English well enough to complete study treatment and assessments in English

Exclusion criteria are:

• the youth or parent has a psychiatric or medical condition that would interfere with their ability to participate in study assessments and/or treatment (such as acute psychosis, neurological impairment, malnutrition due to anorexia)

Sites / Locations

  • Michele BerkRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PI+ Inpatient Treatment as Usual

Inpatient Treatment alone

Arm Description

Standard inpatient treatment delivered in the context of an adolescent psychaitric inpatient unit plus an 4 session DBT-based parenting intervention PI) Intervention: Behavioral: DBT-Based Parenting Intervention

No parenting intervention provided beyond what is part of the inpatient treatment as usual. Intervention: Behavioral: Treatment as Usual

Outcomes

Primary Outcome Measures

Columbia Suicide Severity Rating Scale (Posner et al., 2011) and the Suicide Attempt Self-Injury Interview (SASII; Linehan et al., 2006), Face Sheets
Structured Interviews measuring the number of suicide attempts and non-suicidal self-injury episodes
Suicide Ideation Questionnaire Jr. (Reynolds, 1988) (SIQ- Jr; Reynolds, 1988)
Self Report Measure of suicidal ideation, total score greater than 31 = clinical concern

Secondary Outcome Measures

Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)
Parent emotion dysregulation, higher score = greater dysregulation.
Center for Epidemiological Studies Depression Scale (CES-D, Radloff, 1977), scores range 0-60, greater than 16 = clinical concern for depressive episode
Self-report of depressive symptoms, total score of 16 or above = possible depressive episode
Caregiver Strain Questionnaire Short Form 7(CGSQ-SF7; Brannan et al., 1997) Questionnaire (CGSQ; Brannan et al., 1997)
Self-report measure of caregiver strain as a result of taking care of a child with mental health difficulties, scores range from 0-35.
Conflict Behavior Questionnaire (CBQ; Robin & Foster, 1989)
Self-report measures of family conflict, to be completed by both parents and youth, higher scores = greater conflict

Full Information

First Posted
March 7, 2021
Last Updated
May 9, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04797455
Brief Title
Parent Intervention for Psychiatrically-Hospitalized Youth
Official Title
Pilot Intervention for Parents of Psychiatrically-Hospitalized Youth
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
November 1, 2025 (Anticipated)
Study Completion Date
June 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 attempt(s), 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 (i.e., 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 (i.e., they will receive treatment as usual). Study participation is optional and will not impact the family's 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent - Emotional Problem, Suicide and Self-harm, Parenting
Keywords
suicide, Self-Injurious Behavior, Behavioral Symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PI+ Inpatient Treatment as Usual
Arm Type
Experimental
Arm Description
Standard inpatient treatment delivered in the context of an adolescent psychaitric inpatient unit plus an 4 session DBT-based parenting intervention PI) Intervention: Behavioral: DBT-Based Parenting Intervention
Arm Title
Inpatient Treatment alone
Arm Type
Active Comparator
Arm Description
No parenting intervention provided beyond what is part of the inpatient treatment as usual. Intervention: Behavioral: Treatment as Usual
Intervention Type
Behavioral
Intervention Name(s)
DBT-Based Parenting Intervention
Intervention Description
The intervention will consist of 4 individual telehealth parent sessions, to be completed within one month after the teen discharges from the inpatient hospital or within one month of linkage to care whatever comes first . Sessions will be 60-90 minute 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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual
Intervention Description
No parenting intervention provided beyond standard practices on the adolescent psychiatric inpatient unit.
Primary Outcome Measure Information:
Title
Columbia Suicide Severity Rating Scale (Posner et al., 2011) and the Suicide Attempt Self-Injury Interview (SASII; Linehan et al., 2006), Face Sheets
Description
Structured Interviews measuring the number of suicide attempts and non-suicidal self-injury episodes
Time Frame
3, 6, 12 months from baseline
Title
Suicide Ideation Questionnaire Jr. (Reynolds, 1988) (SIQ- Jr; Reynolds, 1988)
Description
Self Report Measure of suicidal ideation, total score greater than 31 = clinical concern
Time Frame
3, 6, 12 months from baseline
Secondary Outcome Measure Information:
Title
Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)
Description
Parent emotion dysregulation, higher score = greater dysregulation.
Time Frame
3, 6, 12 months from baseline
Title
Center for Epidemiological Studies Depression Scale (CES-D, Radloff, 1977), scores range 0-60, greater than 16 = clinical concern for depressive episode
Description
Self-report of depressive symptoms, total score of 16 or above = possible depressive episode
Time Frame
3, 6, 12 months from baseline
Title
Caregiver Strain Questionnaire Short Form 7(CGSQ-SF7; Brannan et al., 1997) Questionnaire (CGSQ; Brannan et al., 1997)
Description
Self-report measure of caregiver strain as a result of taking care of a child with mental health difficulties, scores range from 0-35.
Time Frame
3, 6, 12 months from baseline
Title
Conflict Behavior Questionnaire (CBQ; Robin & Foster, 1989)
Description
Self-report measures of family conflict, to be completed by both parents and youth, higher scores = greater conflict
Time Frame
3, 6, 12 months from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria are: youth is currently hospitalized on the Stanford unit at Mills Peninsula Medical Center, on the Inpatient Adolescent Psychiatry Unit, for suicidal ideation and/or a suicide attempt. youth is between the ages of 12-18 (18 year-old youth must still be in high school and living at home with parents for the duration of the study) at least one parent/guardian is willing to participate in the study intervention youth and parent speak English well enough to complete study treatment and assessments in English Exclusion criteria are: • the youth or parent has a psychiatric or medical condition that would interfere with their ability to participate in study assessments and/or treatment (such as acute psychosis, neurological impairment, malnutrition due to anorexia)
Facility Information:
Facility Name
Michele Berk
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele Berk
Phone
650-736-0077
Email
mberk2@stanford.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Parent Intervention for Psychiatrically-Hospitalized Youth

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