Parent Intervention for Psychiatrically-Hospitalized Youth

Официальное название

Pilot Intervention for Parents of Psychiatrically-Hospitalized Youth

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое Treatment as usual
  No parenting intervention provided beyond standard practices on the adolescent psychiatric inpatient unit.

Первичные конечные точки

• Columbia Suicide Severity Rating Scale (Posner et al., 2011) and the Suicide Attempt Self-Injury Interview (SASII; Linehan et al., 2006), Face Sheets [Срок оценки: 3, 6, 12 months from baseline]
• Suicide Ideation Questionnaire Jr. (Reynolds, 1988) (SIQ- Jr; Reynolds, 1988) [Срок оценки: 3, 6, 12 months from baseline]

Вторичные конечные точки (4)

• Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004) [Срок оценки: 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 [Срок оценки: 3, 6, 12 months from baseline]
• Caregiver Strain Questionnaire Short Form 7(CGSQ-SF7; Brannan et al., 1997) Questionnaire (CGSQ; Brannan et al., 1997) [Срок оценки: 3, 6, 12 months from baseline]
• Conflict Behavior Questionnaire (CBQ; Robin & Foster, 1989) [Срок оценки: 3, 6, 12 months from baseline]

Критерии участия

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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Michele Berk — Stanford

Идентификаторы

NCT: NCT04797455 · 59389

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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