Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04132284 |
| Other study ID # |
50613 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2020 |
| Est. completion date |
June 16, 2023 |
Study information
| Verified date |
November 2023 |
| Source |
Stanford University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
