Parent Intervention for Psychiatrically-Hospitalized Youth

NCT04797455 | Recruiting

• 1 other identifier: 59389
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

suicide; Self-Injurious Behavior; Behavioral Symptoms

Outcome Measures

Primary Outcomes (2)

• 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

  3, 6, 12 months from baseline

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

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

  3, 6, 12 months from baseline

Secondary Outcomes (4)

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

  3, 6, 12 months from baseline

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

  3, 6, 12 months from baseline

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

  3, 6, 12 months from baseline

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

  3, 6, 12 months from baseline

Study Arms (2)

PI+ Inpatient Treatment as Usual

EXPERIMENTAL

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

Inpatient Treatment alone

ACTIVE COMPARATOR

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

Behavioral: Treatment as usual

Interventions

DBT-Based Parenting Intervention BEHAVIORAL

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.

PI+ Inpatient Treatment as Usual

Treatment as usual BEHAVIORAL

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

Inpatient Treatment alone; PI+ Inpatient Treatment as Usual

Eligibility Criteria

• Age: 12 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Michele Berk

Stanford, California, 94305, United States

RECRUITING

MeSH Terms

Conditions

Suicide; Self-Injurious Behavior; Behavioral Symptoms

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 7, 2021
• First Posted: March 15, 2021
• Study Start: May 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)