Improving Screening and Follow Up for Suicidal Ideation and Behaviors Among Latinx Youth in Primary Care

Suicidal Ideation Clinical Trial

Official title:

Improving Screening and Follow Up for Suicidal Ideation and Behaviors Among Latinx Youth in Primary Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06229223
• Other study ID #: IRB00378575
• Secondary ID: R34MH129771
• Status: Recruiting
• Phase: N/A
• Start date: March 26, 2024
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: Johns Hopkins University
• Contact: Ellen Molino
• Phone: 14105509019
• Email: emolino1[@]jh.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this proposal is to develop and pilot a systems-level strategy in pediatric primary care to enhance identification and management of suicidal ideation and behavior in Latinx youth, particularly those in immigrant families with parents who have limited English proficiency (LEP). The investigators will focus on the use of trained community health workers (CHWs) to increase clinic capacity and quality of suicide risk screening and early intervention, with a focus on safety planning, parent psychoeducation and care coordination. Specific aims are 1: To develop site-specific implementation protocols for the integration of CHWs into SIB screening and safety planning for Latinx youth and the youths families; 2: To pilot the implementation of the program in a six-month open trial in four pediatric primary care practices representing a range of usual practice settings; and 3: To engage a stakeholder network to explore barriers and facilitators, including costs and billing strategies, to implementation of this approach across a broad range of pediatric primary care settings. Parents/guardians of youth who have been referred to and agree to participate in the intervention by the child's primary care provider will participate in a 2-month program consisting of 6-8 phone sessions with a community health worker focusing on safety planning, information/education, program solving and self-care. Research participants will be asked to complete a survey via phone at the beginning of the program and another at the end of the program. The participants may also be asked to participate in an additional interview about the study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 100 Years

Eligibility

Inclusion Criteria:

• Youth and their parents who work with the community health worker and
• who speak English or Spanish and
• identify as Latino/Latinx/Hispanic/Latin American are eligible for enrollment in the study

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Suicidal Ideation

Intervention

Behavioral:
• PALOMA
Partnering with Parents of Adolescent Latinos on Mental Health Assistance

Locations

Country	Name	City	State
United States	BMS at Yard 56	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Participants Screened	Percent of patients 12-18 years old screened for depression and suicidal ideation and behavior at clinic level	Monthly for 9 months
Primary	Feasibility as assessed by percent of sessions completed	Percent of eligible patients receiving a CHW session	Monthly for 9 months
Primary	Quality as assessed by percent of CHW visits	Percent of CHW visits that include delivery of one or more intervention components	Monthly for 9 months
Primary	Engagement as assessed by number of follow-up visits	number of follow-up mental health visits with PCP or specialty provider among youth identified as having suicidal ideation or behavior.	Monthly for 9 months
Secondary	Family Functioning as assessed by the SCORE-15 Index of Family Functioning and Change (SCORE-15)	SCORE-15 Index of Family Functioning and Change: Score range 5-15, higher total means worse functioning.	Baseline and 3 months
Secondary	Parent Self Efficacy as assessed by Brief Parenting Self Efficacy Scale (BPSES) Questionnaire	Brief Parenting Self Efficacy Scale (BPSES) Questionnaire: Total score ranges from 5 to 25, higher scores indicate higher levels of parental self-efficacy.	Baseline and 3 months
Secondary	Depression as assessed by the Patient Health Questionnaire - Adolescent (PHQ-A)	Patient Health Questionnaire - Adolescent (PHQ-A): Each item on the PHQ-A is scored as follows: Not at all = 0 Several Days = 1 More than half the days = 2 Nearly every day = 3. A weighted score of 5 or more means a positive screen for depressive symptoms. A weighted score of 0-4 means a negative screen for depressive symptoms.	Baseline and 3 months
Secondary	Suicidal Ideation and Behavior as assessed by the Ask Suicide-Screening Questionnaire (ASQ)	Ask Suicide-Screening Questionnaire (ASQ): 4 Yes or No Questions. "Yes" to questions 1 through 4, or refuses to answer is considered a positive screen. "Yes" to question 5 = acute positive screen (imminent risk identified); "No" to question 5 = non-acute positive screen.	Baseline and 3 months