Michele Berk
Stanford, California, 94305, United States
Location status: Recruiting
NCT Number: NCT04797455
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.
Interested in participating?
Request Info12 year–85 year
All sexes
Interventional
Not applicable
Stanford, California, 94305, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
are:
Exclusion criteria
are:
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.
No parenting intervention provided beyond standard practices on the adolescent psychiatric inpatient unit.
Time frame: 3, 6, 12 months from baseline
Structured Interviews measuring the number of suicide attempts and non-suicidal self-injury episodes
Time frame: 3, 6, 12 months from baseline
Self Report Measure of suicidal ideation, total score greater than 31 = clinical concern
Time frame: 3, 6, 12 months from baseline
Parent emotion dysregulation, higher score = greater dysregulation.
Time frame: 3, 6, 12 months from baseline
Self-report of depressive symptoms, total score of 16 or above = possible depressive episode
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.
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
Stanford University
Other
Pilot Intervention for Parents of Psychiatrically-Hospitalized Youth
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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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