Mental HealthNCT03651050
Implementing a Digital Child Mental Health Screening, Literacy, and Management Tool in Faith-Based Settings
A study testing Faith Based Outreach (FBO) and community-health-workers (CHW) in people with Mental Health, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health
- What is being tested?
- Faith Based Outreach (FBO) and community-health-workers (CHW)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 319 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University Langone Health
New York, New York, 10016
About this study
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.
- Conditions
- Mental Health
- Being tested
- Faith Based Outreach (FBO), community-health-workers (CHW)
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faith Based Outreach (FBO)Behavioural
Faith base outreach groups will be trained in P-MHDT
community-health-workers (CHW)Behavioural
COmmon health workers will be trained in P-MHDT
| Study group | Role | What they receive |
|---|---|---|
| intervention FBOs receive the P-MHDT | Experimental | Not described Receives: Behavioral: Faith Based Outreach (FBO) |
| control FBOs receive no P-MHDT | Experimental | Not described Receives: Behavioral: community-health-workers (CHW) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aggression measured by parent report
Measured: 24 Months
Anxiety measured by parent report
Measured: 24 Months
Depression measured by parent report
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start1 Aug 2019
- Primary completion30 Aug 2020
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keng-Yen Huang, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03651050
- Sponsor's protocol ID
- 18-00728
- Status last verified
- Dec 2021
- First submitted
- 27 Aug 2018
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a Digital Child Mental Health Screening, Literacy, and Management Tool in Faith-Based Settings
- ClinicalTrials.gov ID
- NCT03651050
- Acronym / sponsor ID
- 18-00728
- Conditions
- Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 29 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention FBOs receive the P-MHDT | Experimental | Behavioral: Faith Based Outreach (FBO) |
| control FBOs receive no P-MHDT | Experimental | Behavioral: community-health-workers (CHW) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Faith Based Outreach (FBO)Faith base outreach groups will be trained in P-MHDT | Behavioural | intervention FBOs receive the P-MHDT |
| community-health-workers (CHW)COmmon health workers will be trained in P-MHDT | Behavioural | control FBOs receive no P-MHDT |
Primary outcome
Aggression measured by parent report
Time frame: 24 Months
Anxiety measured by parent report
Time frame: 24 Months
Depression measured by parent report
Time frame: 24 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keng-Yen Huang, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Faith Based Outreach (FBO) and community-health-workers (CHW) in people with Mental Health, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aggression measured by parent report (time frame: 24 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2021.