Adolescent - Emotional ProblemNCT04797455
Parent Intervention for Psychiatrically-Hospitalized Youth
A study testing DBT-Based Parenting Intervention and Treatment as usual in people with Adolescent - Emotional Problem and Suicide and Self-harm, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 85 years
- Conditions the study is for
- Adolescent - Emotional Problem, Suicide and Self-harm, Parenting
- What is being tested?
- DBT-Based Parenting Intervention and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 31 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Michele Berk
Stanford, California, 94305
Michele Berk, 6507360077, mberk2@stanford.edu
About this study
Official title: Pilot Intervention for Parents of Psychiatrically-Hospitalized Youth
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.
Read the detailed 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.
- Being tested
- DBT-Based Parenting Intervention, Treatment as usual
- Keywords
- suicide, Self-Injurious Behavior, Behavioral Symptoms
- Medical subject headings
- Suicide, Self-Injurious Behavior, Behavioral Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBT-Based Parenting InterventionBehavioural
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 usualBehavioural
No parenting intervention provided beyond standard practices on the adolescent psychiatric inpatient unit.
| Study group | Role | What they receive |
|---|---|---|
| PI+ Inpatient Treatment as Usual | Experimental | 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 Receives: Behavioral: DBT-Based Parenting Intervention; Behavioral: Treatment as usual |
| Inpatient Treatment alone | Active comparator | No parenting intervention provided beyond what is part of the inpatient treatment as usual.
Intervention: Behavioral: Treatment as Usual Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3, 6, 12 months from baseline
Suicide Ideation Questionnaire Jr. (Reynolds, 1988) (SIQ- Jr; Reynolds, 1988)
Self Report Measure of suicidal ideation, total score greater than 31 = clinical concern
Measured: 3, 6, 12 months from baseline
Secondary outcomes (4)
Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)
Parent emotion dysregulation, higher score = greater dysregulation.
Measured: 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
Self-report of depressive symptoms, total score of 16 or above = possible depressive episode
Measured: 3, 6, 12 months from baseline
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.
Measured: 3, 6, 12 months from baseline
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
Measured: 3, 6, 12 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start1 May 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent - Emotional ProblemStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Berk, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04797455
- Sponsor's protocol ID
- 59389
- Status last verified
- Jul 2026
- First submitted
- 7 Mar 2021
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No