Clinical trial NCT04132284: 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
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent - Emotional Problem
Suicide and Self-harm
Parenting
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-10-18
Enrollment: 91
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Number of Youth Self-Harm Episodes
timeFrame: 6 months
measure: Youth Suicidal Ideation
timeFrame: 6 months
Secondary outcomes:
measure: Parent Emotion Dysregulation
timeFrame: 6 months
measure: Parent Depressive Symptoms
timeFrame: 6 months
measure: Parent Caregiver Strain
timeFrame: 6 months
measure: Family Conflict
timeFrame: 6 months
measure: Family Functioning McMaster Family Assessment Device
timeFrame: 6 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
References: