Parent Intervention for Psychiatrically-Hospitalized Youth

Parenting Clinical Trial

Official title:

Pilot Intervention for Parents of Psychiatrically-Hospitalized Youth

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04797455
• Other study ID #: 59389
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: June 1, 2026

Study information

• Verified date: May 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 1, 2026
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Michele Berk	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)	Parent emotion dysregulation, higher score = greater dysregulation.	3, 6, 12 months from baseline
Secondary	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	3, 6, 12 months from baseline
Secondary	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.	3, 6, 12 months from baseline
Secondary	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	3, 6, 12 months from baseline