CClinicalTrials.gg
CompletedNCT03651050Updated Dec 9, 2021

Implementing a Digital Child Mental Health Screening, Literacy, and Management Tool in Faith-Based Settings

An interventional study of Faith Based Outreach (FBO) and community-health-workers (CHW) in Mental Health, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-09.

Sponsored by NYU Langone Health · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
319
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Mental Health
03

In context

Lead sponsor

NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.

Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
319 participants (actual)

Study arms

  • Experimental
    intervention FBOs receive the P-MHDT

    Behavioral: Faith Based Outreach (FBO)

  • Experimental
    control FBOs receive no P-MHDT

    Behavioral: community-health-workers (CHW)

Interventions

  • BehavioralFaith Based Outreach (FBO)

    Faith base outreach groups will be trained in P-MHDT

  • Behavioralcommunity-health-workers (CHW)

    COmmon health workers will be trained in P-MHDT

06

What researchers measure

Primary outcomes

  1. Aggression measured by parent report

    Time frame: 24 Months

  2. Anxiety measured by parent report

    Time frame: 24 Months

  3. Depression measured by parent report

    Time frame: 24 Months

07

Study locations

1 site
  • New York University Langone Health
    New York, New York 10016, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03651050
Lead sponsor
NYU Langone Health
Responsible party
Sponsor
First posted
Aug 29, 2018
Start date
Aug 1, 2019
Primary completion
Aug 30, 2020
Completion
Aug 1, 2021
Last update
Dec 9, 2021

Study contacts

Keng-Yen Huang, MD
principal investigator · NYU Langone Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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