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RecruitingNCT04797455Updated Aug 3, 2026

Parent Intervention for Psychiatrically-Hospitalized Youth

An interventional study of DBT-Based Parenting Intervention and Treatment as usual in Adolescent - Emotional Problem, Suicide and Self-harm and Parenting, sponsored by Stanford University. Recruiting at 1 site in United States. Open to participants aged 12 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-08-03.

Sponsored by Stanford University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
12 Years to 85 Years
Sex
All
01

Study 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.

Read the detailed description

The present study is a pilot parent coaching intervention (PI). The investigators will enroll N = 40 pairs of youth and parents enrolled in an adolescent psychiatric inpatient program. This program, called the Stanford at Mills-Peninsula Hospital (STAM), is jointly run by Stanford and Mills-Peninsula Hospital. 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 PI + standard Inpatient treatment or standard inpatient treatment only. Parents assigned to the PI + inpatient treatment will be offered 4 sessions of DBT-based parenting interventions which include safety planning, behavioral parenting interventions, and support for care linkage. Youth will participate in study assessments only and will not receive additional treatment as part of the study (i.e., they will receive treatment as usual). Study participation is optional and will not impact the family's ability to participate in the inpatient treatment. Youth will stay admitted to the inpatient 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, 6 month follow-up, and 12-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 4 individual parent sessions, to be completed within one month of youth discharge from the hospital or of care linkage whichever coms first. Sessions will be 60 to 90 minutes 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. Sessions will focus on safety planning and care linkage, Parent skills building, parent conflict resolution, and parent self-care using adolescent DBT handouts.

02

Conditions studied

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

Keywords

  • suicide
  • Self-Injurious Behavior
  • Behavioral Symptoms
03

Who can participate

Ages eligible
12 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

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)
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (estimated)

Study 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

    Behavioral: DBT-Based Parenting Intervention · Behavioral: Treatment as usual

  • Active comparator
    Inpatient Treatment alone

    No parenting intervention provided beyond what is part of the inpatient treatment as usual. Intervention: Behavioral: Treatment as Usual

    Behavioral: Treatment as usual

Interventions

  • BehavioralDBT-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.

  • BehavioralTreatment as usual

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

05

What researchers measure

Primary outcomes

  1. Columbia Suicide Severity Rating Scale (Posner et al., 2011) and the Suicide Attempt Self-Injury Interview (SASII; Linehan et al., 2006), Face Sheets

    Structured Interviews measuring the number of suicide attempts and non-suicidal self-injury episodes

    Time frame: 3, 6, 12 months from baseline

  2. Suicide Ideation Questionnaire Jr. (Reynolds, 1988) (SIQ- Jr; Reynolds, 1988)

    Self Report Measure of suicidal ideation, total score greater than 31 = clinical concern

    Time frame: 3, 6, 12 months from baseline

Secondary outcomes

  1. Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)

    Parent emotion dysregulation, higher score = greater dysregulation.

    Time frame: 3, 6, 12 months from baseline

  2. Center for Epidemiological Studies Depression Scale (CES-D, Radloff, 1977), scores range 0-60, greater than 16 = clinical concern for depressive episode

    Self-report of depressive symptoms, total score of 16 or above = possible depressive episode

    Time frame: 3, 6, 12 months from baseline

  3. Caregiver Strain Questionnaire Short Form 7(CGSQ-SF7; Brannan et al., 1997) Questionnaire (CGSQ; Brannan et al., 1997)

    Self-report measure of caregiver strain as a result of taking care of a child with mental health difficulties, scores range from 0-35.

    Time frame: 3, 6, 12 months from baseline

  4. Conflict Behavior Questionnaire (CBQ; Robin & Foster, 1989)

    Self-report measures of family conflict, to be completed by both parents and youth, higher scores = greater conflict

    Time frame: 3, 6, 12 months from baseline

06

Study locations

1 of 1 sites recruiting
  • Michele Berk
    Stanford, California 94305, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04797455
Lead sponsor
Stanford University
Responsible party
Michele Berk (Assistant Professor, Stanford University) — Principal investigator
First posted
Mar 15, 2021
Start date
May 1, 2023
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Aug 3, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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