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NCT Number: NCT04797455

Parent Intervention for Psychiatrically-Hospitalized Youth

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.

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Key information

Age range

12 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Michele Berk

Stanford, California, 94305, United States

Location status: Recruiting

Location contact

Michele Berk

CONTACT

[email protected]

650-736-0077

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Treatment as Usual

Behavioral

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

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

    Time frame: 3, 6, 12 months from baseline

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

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

    Time frame: 3, 6, 12 months from baseline

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

Secondary outcomes

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

    Time frame: 3, 6, 12 months from baseline

    Parent emotion dysregulation, higher score = greater dysregulation.

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

    Time frame: 3, 6, 12 months from baseline

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

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

    Time frame: 3, 6, 12 months from baseline

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

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

    Time frame: 3, 6, 12 months from baseline

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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Pilot Intervention for Parents of Psychiatrically-Hospitalized Youth

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 15, 2021
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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