Parent Intervention for Psychiatrically-Hospitalized Youth
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-85
SponsorStanford University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
DBT-Based Parenting Intervention
BehavioralThe 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
BehavioralNo parenting intervention provided beyond standard practices on the adolescent psychiatric inpatient unit.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: PI+ Inpatient Treatment as UsualExperimental treatment 2 interventions
Group B: Inpatient Treatment aloneActive comparator 1 intervention
Trial outcomes
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
Structured Interviews measuring the number of suicide attempts and non-suicidal self-injury episodes
Time frame
3, 6, 12 months from baseline2
Suicide Ideation Questionnaire Jr. (Reynolds, 1988) (SIQ- Jr; Reynolds, 1988)
Self Report Measure of suicidal ideation, total score greater than 31 = clinical concern
Time frame
3, 6, 12 months from baselineSecondary outcomes
1
Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)
Parent emotion dysregulation, higher score = greater dysregulation.
Time frame
3, 6, 12 months from baseline2
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
Time frame
3, 6, 12 months from baseline3
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.
Time frame
3, 6, 12 months from baseline4
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
Time frame
3, 6, 12 months from baselineSponsors and contacts
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Source ClinicalTrials.gov