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

NCT ID: NCT04132284

Last Updated: 2023-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2023-06-16

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

DBT IOP plus DBT PI

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)

Group Type: EXPERIMENTAL

DBT-Based Parenting Intervention

Intervention Type: 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 alone

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

Group Type: ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type: BEHAVIORAL

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

Interventions

DBT-Based Parenting Intervention

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

Treatment as Usual

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

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Michele Berk

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stanford University

Palo Alto, California, United States

Countries

United States

Other Identifiers

50613

Identifier Type: -

Identifier Source: org_study_id