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DBT-Based Parenting Intervention for Parents of Youth at Risk for Suicide

Primary Purpose

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

Status
Enrolling by invitation
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

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1) youth is enrolled in CHC-Stanford RISE program; 2) youth and parent are willing to participate, and 3) youth and parent speak English.

Exclusion Criteria:

1) 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 severe anorexia).

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DBT IOP plus DBT PI

DBT IOP alone

Arm Description

Standard Dialectical Behavior Therapy (DBT) delivered in the context of an intensive outpatient program (DBT IOP) for adolescents plus an 8-10 session DBT-based parenting intervention (DBT PI)

No parenting intervention provided beyond what is part of the DBT IOP treatment as usual.

Outcomes

Primary Outcome Measures

Number of Youth Self-Harm Episodes
Youth Suicidal Ideation

Secondary Outcome Measures

Parent Emotion Dysregulation
Parent Depressive Symptoms
Parent Caregiver Strain
Family Conflict
Family Functioning McMaster Family Assessment Device

Full Information

First Posted
October 15, 2019
Last Updated
December 7, 2022
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04132284
Brief Title
DBT-Based Parenting Intervention for Parents of Youth at Risk for Suicide
Official Title
Pilot Randomized Controlled Trial of a DBT-based Parenting Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2024 (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 an 8-10 session DBT-based parenting intervention (DBT PI) plus standard Dialectical Behavior Therapy delivered in the context of an intensive outpatient program (DBT IOP) to DBT IOP alone. The long term goal of the research is to determine if augmenting standard DBT 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 RCT of a DBT parenting intervention (DBT PI). The investigators will enroll N = 40 pairs of youth and parents enrolled in a DBT intensive outpatient program that delivers standard DBT (DBT IOP). This program, called the RISE program, is jointly run by Stanford and Children's Health Council (CHC). CHC is a community mental health clinic located in Palo Alto and is where the IOP is housed. 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 DBT PI + DBT IOP or DBT IOP only. Parents assigned to the DBT PI + DBT IOP will be offered 10 sessions of DBT-based parenting interventions. Youth will participate in study assessments only and will not receive additional treatment as part of the study (i.e., they will receive DBT IOP only). Study participation is optional and will not impact the family's ability to participate in the DBT IOP. Youth will be enrolled in the IOP 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 (end of DBT IOP program) and 6 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 8-10 individual parent sessions, to be completed within one week after the teen completes the IOP program. Sessions will be 1 hour 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 10. Sessions will follow the standard agenda used for DBT skills training: 1) mindfulness practice, 2) homework review, 3) teaching of a new skill; 4) practice of the new skill; and 5) assignment of new homework (Linehan, 1993). The intervention will utilize the Middle Path module from the DBT Skills Manual for Adolescents (Rathus & Miller, 2015), which was created by the developers of DBT for adolescents and includes both instructions for therapists and handouts for clients.

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
DBT IOP plus DBT PI
Arm Type
Experimental
Arm Description
Standard Dialectical Behavior Therapy (DBT) delivered in the context of an intensive outpatient program (DBT IOP) for adolescents plus an 8-10 session DBT-based parenting intervention (DBT PI)
Arm Title
DBT IOP alone
Arm Type
Active Comparator
Arm Description
No parenting intervention provided beyond what is part of the DBT IOP treatment as usual.
Intervention Type
Behavioral
Intervention Name(s)
DBT-Based Parenting Intervention
Intervention Description
The intervention will consist of 8-10 individual parent sessions, to be completed within one week after the teen completes the IOP program. Sessions will be 1 hour 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 10. Sessions will follow the standard agenda used for DBT skills training: 1) mindfulness practice, 2) homework review, 3) teaching of a new skill; 4) practice of the new skill; and 5) assignment of new homework (Linehan, 1993). The intervention will utilize the Middle Path module of the DBT Skills Manual for Adolescents (Rathus & Miller, 2015), which was created by the developers of DBT for adolescents and includes both instructions for therapists and handouts for clients.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Intervention Description
No parenting intervention provided beyond standard practices in DBT IOP program.
Primary Outcome Measure Information:
Title
Number of Youth Self-Harm Episodes
Time Frame
6 months
Title
Youth Suicidal Ideation
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Parent Emotion Dysregulation
Time Frame
6 months
Title
Parent Depressive Symptoms
Time Frame
6 months
Title
Parent Caregiver Strain
Time Frame
6 months
Title
Family Conflict
Time Frame
6 months
Title
Family Functioning McMaster Family Assessment Device
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1) youth is enrolled in CHC-Stanford RISE program; 2) youth and parent are willing to participate, and 3) youth and parent speak English. Exclusion Criteria: 1) 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 severe anorexia).
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94306
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

DBT-Based Parenting Intervention for Parents of Youth at Risk for Suicide

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