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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03651050
Other study ID # 18-00728
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2019
Est. completion date August 1, 2021

Study information

Verified date December 2021
Source NYU Langone Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The proposed project is to develop a Pediatric-Mental Health Digital Toolkit (P-MHDT) Toolkit to support innovative child mental health preventive interventions in FBO settings. This project focuses on developing a P-MHDT and carrying out a pilot feasibility evaluation in real world settings. A group of Mental Health Professionals (MHPs)/ Community Healthcare Workers (CHWs) will be trained and the P-MHDT Toolkit intervention will be tested in 6 Faith Based Organizations (FBOs) in Uganda.


Description:

The specific aims of this proposed study include: Aim 1. To develop a P-MHDT (by employing qualitative focus-group interviews and user-centered design to enhance usability). Aim 2. To train mental health professionals and community health workers (CHWs) for the P-MHDT approach of child mental health promotion in Uganda (including monitoring impacts of training on CHWs' program implementation competency). Aim 3 (11-24 month). To estimate impacts of the P-MHDT on FBOs and families (i.e., caregivers' mental health literacy, practices, and children's mental health) when implemented in the real world FBO settings.


Recruitment information / eligibility

Status Completed
Enrollment 319
Est. completion date August 1, 2021
Est. primary completion date August 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Participants must be at least 18 years of age. Participating parents must be caregivers of age 1-7 years old children. - Children are not the subjects of this study, and will not participate in research activities. Exclusion Criteria: - Evidence of psychopathology or cognitive impairment severe enough to preclude giving consent, or completing the survey instruments or the focus group of the study. - Minors (age <18) will also be excluded.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Faith Based Outreach (FBO)
Faith base outreach groups will be trained in P-MHDT
community-health-workers (CHW)
COmmon health workers will be trained in P-MHDT

Locations

Country Name City State
United States New York University Langone Health New York New York

Sponsors (1)

Lead Sponsor Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Aggression measured by parent report 24 Months
Primary Anxiety measured by parent report 24 Months
Primary Depression measured by parent report 24 Months
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