Recruiting

Observational Study

Sponsor:

Stanford University

Code:

NCT04797455

Conditions

Adolescent - Emotional Problem

Suicide and Self-harm

Parenting

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Not accepted

Interventions

DBT-Based Parenting Intervention

Treatment as usual

Study Details

Brief summary:

The purpose of the present study is to conduct a pilot randomized clinical trial (RCT) of a parent coaching intervention for parents of youth hospitalized for suicidal ideation, suicide attempt(s), or non-suicidal self-injury. Parents will receive either the parent coaching intervention (which includes safety planning and behavioral parenting skills training with a clinician and assistance with linkage to follow-up care by a case manager) or treatment as usual (TAU) for the inpatient unit. The long-term goal of the research is to determine if augmenting standard inpatient treatment 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

Study ID

NCT04797455

Start date

May 1, 2023

Status verified date

Jul, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Not accepted

Inclusion criteria are:

  • youth is currently hospitalized on the Stanford unit at Mills Peninsula Medical Center, on the Inpatient Adolescent Psychiatry Unit, for suicidal ideation and/or a suicide attempt.
  • youth is between the ages of 12-18 (18 year-old youth must still be in high school and living at home with parents for the duration of the study)
  • at least one parent/guardian is willing to participate in the study intervention
  • youth and parent speak English well enough to complete study treatment and assessments in English

Exclusion criteria are:

• 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 anorexia)

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PI+ Inpatient Treatment as Usual

Standard inpatient treatment delivered in the context of an adolescent psychaitric inpatient unit plus an 4 session DBT-based parenting intervention PI)

Intervention: Behavioral: DBT-Based Parenting Intervention

active comparator: Inpatient Treatment alone

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

Intervention: Behavioral: Treatment as Usual

Interventions

DBT-Based Parenting Intervention

The intervention will consist of 4 individual telehealth parent sessions, to be completed within one month after the teen discharges from the inpatient hospital or within one month of linkage to care whatever comes first . Sessions will be 60-90 minute 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 4.

Treatment as usual

No parenting intervention provided beyond standard practices on the adolescent psychiatric inpatient unit.

Primary outcome measure

  • Columbia Suicide Severity Rating Scale (Posner et al., 2011) and the Suicide Attempt Self-Injury Interview (SASII; Linehan et al., 2006), Face Sheets [ Time Frame: 3, 6, 12 months from baseline ]
  • Suicide Ideation Questionnaire Jr. (Reynolds, 1988) (SIQ- Jr; Reynolds, 1988) [ Time Frame: 3, 6, 12 months from baseline ]

Central Contacts and Locations

Locations

Michele Berk

Recruiting

Stanford, California, United States, 94305

Contacts

Michele Berk

6507360077mberk2@stanford.edu

More Information

Sponsor

Stanford University

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Keywords

  • suicide
  • Self-Injurious Behavior
  • Behavioral Symptoms

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-08-03.