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

NCT04132284 | Completed

• 1 other identifier: 50613
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Number of Youth Self-Harm Episodes

  6 months

• Youth Suicidal Ideation

  6 months

Secondary Outcomes (5)

• Parent Emotion Dysregulation

  6 months

• Parent Depressive Symptoms

  6 months

• Parent Caregiver Strain

  6 months

• Family Conflict

  6 months

• Family Functioning McMaster Family Assessment Device

  6 months

Study Arms (2)

DBT IOP plus DBT PI

EXPERIMENTAL

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)

Behavioral: DBT-Based Parenting Intervention

DBT IOP alone

ACTIVE COMPARATOR

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

Behavioral: Treatment as Usual

Interventions

DBT-Based Parenting Intervention BEHAVIORAL

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.

DBT IOP plus DBT PI

Treatment as Usual BEHAVIORAL

No parenting intervention provided beyond standard practices in DBT IOP program.

DBT IOP alone

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• \) 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).

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94306, United States

Location

MeSH Terms

Conditions

Suicide; Self-Injurious Behavior

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 15, 2019
• First Posted: October 18, 2019
• Study Start: July 1, 2020
• Primary Completion: December 16, 2022
• Study Completion: June 16, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)