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精神病住院青少年的家长干预

2026年10月30日 更新者:Michele Berk、Stanford University

精神病住院青少年家长的试点干预

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

40

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • California
      • Stanford、California、美国、94305
        • Michele Berk

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

12年 至 85年 (孩子、成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的: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

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.

有源比较器:Inpatient Treatment alone

No parenting intervention provided beyond what is part of the inpatient treatment as usual.

Intervention: Behavioral: Treatment as Usual

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

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Columbia Suicide Severity Rating Scale (Posner et al., 2011) and the Suicide Attempt Self-Injury Interview (SASII; Linehan et al., 2006), Face Sheets
大体时间:3, 6, 12 months from baseline

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)
大体时间:3, 6, 12 months from baseline

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

3, 6, 12 months from baseline

次要结果测量

结果测量
措施说明
大体时间
Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)
大体时间:3, 6, 12 months from baseline

Parent emotion dysregulation, higher score = greater dysregulation.

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
大体时间:3, 6, 12 months from baseline

Self-report of depressive symptoms, total score of 16 or above = possible 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)
大体时间: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.

3, 6, 12 months from baseline
Conflict Behavior Questionnaire (CBQ; Robin & Foster, 1989)
大体时间:3, 6, 12 months from baseline

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

3, 6, 12 months from baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年5月1日

初级完成 (估计的)

2026年12月31日

研究完成 (估计的)

2026年12月31日

研究注册日期

首次提交

2021年3月7日

首先提交符合 QC 标准的

2021年3月11日

首次发布 (实际的)

2021年3月15日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年10月30日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 59389

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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