Parent-Child RelationsNCT04481399
Mobile Health (mHealth) Tools to Improve Delivery Quality of a Family Home Visiting Intervention
A study testing Family Strengthening Intervention for Early Childhood Development and Community Health Worker Routine in people with Parent-Child Relations and Behavioral Intervention, run by Boston College at 1 site in Sierra Leone.
Trial summary
This study will pilot a family-focused, behavioral health intervention while also developing and piloting mHealth tools to support Community Health Workers (CHWs) in Sierra Leone. Read more about this study
- Who is it for?
- Ages 6 months to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Parent-Child Relations, Behavioral Intervention, Exposure to Violent Event
- What is being tested?
- Family Strengthening Intervention for Early Childhood Development and Community Health Worker Routine
- Type of treatment
- Vaccines, Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSierra Leone
- Study dates
- 5 Aug 2021to 16 Aug 2023
- 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 6 months to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Focus Group-User Interface/User Experience (UI/UX) Participants: Aged 18 or older; ability to attend 1-2 sessions (90 minutes per session)
- Family Participants: Families who are (a) a Sierra Leonean household with cohabitating caregivers (e.g., father/mother, mother/grandmother, mother/intimate partner), and child (aged 6-36 months) with both parents aged 18 or older and; (b) one parent scoring at least 62.5 on the Difficulties in Emotion Regulation Scale (DERS). The DERS cut-off score has been used successfully as a risk assessment screening tool in our prior and ongoing studies in Sierra Leone. Sierra Leonean caregivers scoring above this threshold on the DERS have reported significantly higher levels of severe physical punishment with their children as well as intimate partner violence. Both parents must agree to attend FSI-ECD sessions. If enrolled families have more than one child aged 6-36 months, we will include all eligible children as study participants.
- Community Health Worker Participants: CHWs who are 18 years or older and who are assigned to the Peripheral Health Unit that provides health services in one of our target communities.
- Community Health Worker Supervisor Participants: Supervisors are 18 years or older and oversee CHWs providing maternal and child health services
Who cannot join
- Focus Group-User Interface/User Experience (UI/UX) Participants: Individuals younger than age 18 and individuals who do not meet inclusion criteria.
- Family Participants: Families who do not meet all inclusion criteria and/or who are experiencing active family crises (e.g., current suicidality or psychosis, cognitive impairment, ongoing divorce process).
- Community Health Worker Participants: Individuals under age 18 cannot be recruited to work as a CHW.
- Community Health Worker Supervisor Participants: Individuals under age 18.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: mHealth Tools to Improve Service Delivery Quality of an Evidence-Based Family Home Visiting Intervention to Prevent Family Violence Among High Risk Families in Sierra Leone
This study will pilot a family-focused, behavioral health intervention while also developing and piloting mHealth tools to support Community Health Workers (CHWs) in Sierra Leone. This dual focus will help build capacity both for delivery of evidence-based mental health services to reduce family violence and harsh parenting practices, and for effective use of mHealth strategies to improve healthcare delivery quality. This study will leverage Government of Sierra Leone investments in community health initiatives as a strategy to address critical healthcare workforce limitations that plague delivery of evidence-based interventions to vulnerable families in post-conflict Sierra Leone. Study aims are to:
Aim 1. Employ a five-phase user-centered design approach to develop and test mHealth tools to improve training, supervision, and fidelity monitoring of Community Health Workers. Study investigators hypothesize that mHealth tools will be feasible, acceptable, and user-friendly.
Read more
Aim 2. Conduct a Randomized Controlled Pilot Study to assess feasibility, acceptability, costs and preliminary effects of the mHealth-supported delivery of FSI-ECD on parent mental health, emotion regulation, and familial violence in high risk families with children aged 6-36 months (n=40) in comparison to control families (n=40) who receive standard care. Parental mental health, emotion regulation, household violence, and parenting practices will be assessed at baseline, post-intervention and 6-month follow-up. Study investigators hypothesize that (a) the effects of the FSI-ECD will be comparable to results observed with vulnerable families in Rwanda; (b) digital tools will be feasible and acceptable to CHWs and supervisors.
Aim 3. Leverage well-established relationships and government partners to strengthen capacity for mHealth research and quality healthcare delivery in Sierra Leone. Partners include the University of Makeni, the Directorate of Science, Technology and Innovation, and the Ministry of Health and Sanitation.
- Conditions
- Parent-Child Relations, Behavioral Intervention, Exposure to Violent Event, Child Development, Mental Health, Implementation Science
- Being tested
- Family Strengthening Intervention for Early Childhood Development, Community Health Worker Routine
- 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.
Family Strengthening Intervention for Early Childhood DevelopmentBehavioural
The Family Strengthening Intervention for Early Childhood Development (FSI-ECD) is an evidence-based home-visiting behavioral intervention for vulnerable families with children aged 6-36 months. The FSI-ECD targets improving parental emotion regulation and parent-child interactions to improve parental mental health and child development outcomes and reduce family violence. FSI-ECD compromises five core components delivered in 12 modules delivered in weekly sessions via active coaching by community health workers. Core components include coaching on: a) nutrition, health and hygiene; b) early stimulation and playful parenting; c) building resilience and coping skills; d) building problem-solving skills; and d) building emotion regulation and conflict resolution skills.
Community Health Worker RoutineOther
Standard CHW care involves three home visiting sessions delivered to families following childbirth with weekly supervision via phone or face-to-face. Topics of home visiting sessions include: skilled post-natal care for mothers, early initiation of breastfeeding and exclusive breastfeeding practices, adequate nutrition, immunization services and timely use of these services, hand washing and hygiene practices (including waste disposal and food hygiene), building the capacity of family members to appropriately take care of newborns and children under age 5, and building the capacity of family members to recognize and act on postnatal danger signs for newborns, mothers, and children under 5. CHWs also conduct screenings for acute malnutrition and growth monitoring to identify early referrals, and they can provide family planning methods, deworming tablets and other vitamins for acute malnutrition, dehydration, and anti-malaria treatment. Each home-visiting session lasts about 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| FSI-ECD | Experimental | The Family Strengthening Intervention for Early Childhood Development (FSI-ECD) is an evidence-based home-visiting behavioral intervention for vulnerable families with children aged 6-36 months. The FSI-ECD targets improving parental emotion regulation and parent-child interactions to improve parental mental health and child development outcomes and reduce family violence. The FSI-ECD will be delivered in weekly 90-minute home visiting sessions for 12 consecutive weeks. Receives: Behavioral: Family Strengthening Intervention for Early Childhood Development |
| Control | Other | The control is standard maternal and child health home visiting delivered by community health workers. Families will receive three 90-minute home visiting educational sessions focused on nutrition, hygiene, and post-natal care. Receives: Other: Community Health Worker Routine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as assessed through the John Hopkins Implementation and Dissemination Science Scale
Feasibility of mHealth tool implementation to support FSI-ECD delivery will be assessed via a Dissemination and Implementation measures developed by the John Hopkins Bloomberg School of Health. This is a 20-item self-report measure and items are scored on a 4-point Likert scale: 1=not at all, 2=a little bit, 3=a moderate amount, 4=a lot.
Measured: Immediately after the intervention
Acceptability as assessed through the John Hopkins Implementation and Dissemination Science Scale
Acceptability of mHealth tool implementation to support FSI-ECD delivery will be assessed via a Dissemination and Implementation measures developed by the John Hopkins Bloomberg School of Health. This is a 10-item self-report measure and items are scored on a 4-point Likert scale: 1=not at all, 2=a little bit, 3=a moderate amount, 4=a lot.
Measured: Immediately after the intervention
Secondary outcomes (6)
Difficulties in Emotion Regulation Scale (DERS)
The Difficulties in Emotion Regulation Scale (DERS) is a 36-item measure that assesses emotion dysregulation across 6 domains, i.e., non-acceptance of emotional responses, difficulty engaging in goal-directed behavior, impulse control difficulties, lack of emotional awareness, limited access to emotion regulation strategies, and lack of emotional clarity. The DERS is scored on a 5-point Likert scale: 1=Almost Never, 2=Sometimes, 3=About half the time, 4=Most of the time, 5=Almost always. Higher scores indicate greater difficulties in emotion regulation.
Measured: Baseline, immediately after the intervention, and 3-months after the intervention
Conflict Tactics Scale-2 (CTS-2)
The Conflict Tactics Scale (CTS-2) is a 78-item scale (39 behaviors or experiences, each asked once for respondent and one for partner). The CTS is comprised of 5 subscales, i.e., negotiation, psychological aggression, physical assault, injury, and sexual coercion. The response categories gauge the frequency with which acts were used during conflict with a partner in the past year using a 6-point scale ranging from "never" to "20 or more times." There are also response options of "Never in the last year, but it did happen before that," and "This has never happened."
Measured: Baseline, immediately after the intervention, and 3-months after the intervention
Home Observation for Measurement of the Environment (HOME)
The Home Observation for Measurement of the Environment (HOME) is a 43-item measure that assesses the level of stimulation and support provided by caregivers in the home. All items receive a binary score based on the presence (score = 1) or absence (score = 0) of self-reported and direct observation of parenting behaviors and household conditions. Item scores are summed to derive scores on a total scale and the 6 subscales, i.e., variety, organization, acceptance, involvement, learning materials, and responsivity.
Measured: Baseline, immediately after the intervention, and 3-months after the intervention
Observation of Mother-Child Interaction (OMCI)
The Observation of Mother-Child Interaction (OMCI) is a direct observational measure used to assess mother-child interaction during a shared picture-book reading activity that includes maternal (10 items) and child assessments (5 items). Maternal responsive behaviors include contingent responding, emotional-affective support, support for infant foci of attention, and language inputs. Child behaviors include the child's behavioral and social-emotional reactions during the observation. Each item is rated on a 4-point scale: 0 = Never, 1 = Very few, 2 = Sometimes (3-4 times), and 3 = Five or more times. Total scores are assigned for the mother's reaction, the child's reaction, and mother-child interaction, respectively.
Measured: Baseline, immediately after the intervention, and 3-months after the intervention
Hopkins Symptom Checklist (HSCL)
The Hopkins Symptom Checklist (HSCL) is a 25-item inventory that measures symptoms of anxiety and depression. Part I of the measure has 10 items assessing anxiety symptoms and Part II has 15 items assessing depression symptoms. Each item is rated on a 4-point scale: 1 = Not at all, 2 = A little, 3 = Quite a bit, and 4 = Extremely. Item scores are summed to derive scores for the total scale and subscales, i.e., anxiety and depression.
Measured: Baseline, immediately after the intervention and 3-months after the intervention
Post-traumatic Stress Disorder Civilian Checklist
The Post-traumatic Stress Disorder Civilian Checklist is a 17-item scale that assesses symptoms of Post-traumatic Stress Disorder. Items are rated on a binary scale of "yes" or "no" responses.
Measured: Baseline, immediately after the intervention and 3-months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start5 Aug 2021
- Primary completion1 Feb 2023
- Study completion16 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parent-Child RelationsStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston College
- Sponsor type
- University, hospital or other
- Collaborators
- Caritas Freetown, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Alethea Desrosiers, Boston College
- Investigators
- Alethea Desrosiers, PhD, Principal investigator, Boston College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481399
- Sponsor's protocol ID
- 21.006.01
- Other IDs
- R21MH124071
- Status last verified
- Nov 2023
- First submitted
- 15 Jul 2020
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing will be in accordance with the NIH Data Sharing Policy and Implementation Guidance and more specifically the "Data Sharing Expectations for National Institute of Mental Health (NIMH)-funded Clinical Trials". The data generated in this study will be entered into the NIMH Data Archive as required and prescribed by the Notice of Award as well as presented at national and/or international conferences and published in a timely fashion. All final peer-reviewed manuscripts that arise from this proposal will be submitted to the digital archive PubMed Central. Published data will be available in print or electronically from publishers, subject to subscription or printing charges. Research data that document, support and validate research findings will be made available after the main findings from the final research data set have been accepted for publication.
Publications
Desrosiers A, Schafer C, Esliker R, Jambai M, Betancourt T. mHealth-Supported Delivery of an Evidence-Based Family Home-Visiting Intervention in Sierra Leone: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2021 Feb 2;10(2):e25443. doi: 10.2196/25443.
PubMed 33528371
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mHealth Tools to Improve Service Delivery Quality of an Evidence-Based Family Home Visiting Intervention to Prevent Family Violence Among High Risk Families in Sierra Leone
- ClinicalTrials.gov ID
- NCT04481399
- Acronym / sponsor ID
- 21.006.01
- Conditions
- Parent-Child Relations, Behavioral Intervention, Exposure to Violent Event, Child Development, Mental Health, Implementation Science
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Boston CollegeUniversity, hospital or other
- Collaborators
- Caritas Freetown, National Institute of Mental Health (NIMH)
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 16 Aug 2023 (actual)
- First posted
- 22 Jul 2020 (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.
This study will pilot a family-focused, behavioral health intervention while also developing and piloting mHealth tools to support Community Health Workers (CHWs) in Sierra Leone. This dual focus will help build capacity both for delivery of evidence-based mental health services to reduce family violence and harsh parenting practices, and for effective use of mHealth strategies to improve healthcare delivery quality. This study will leverage Government of Sierra Leone investments in community health initiatives as a strategy to address critical healthcare workforce limitations that plague delivery of evidence-based interventions to vulnerable families in post-conflict Sierra Leone. Study aims are to:
Aim 1. Employ a five-phase user-centered design approach to develop and test mHealth tools to improve training, supervision, and fidelity monitoring of Community Health Workers. Study investigators hypothesize that mHealth tools will be feasible, acceptable, and user-friendly.
Aim 2. Conduct a Randomized Controlled Pilot Study to assess feasibility, acceptability, costs and preliminary effects of the mHealth-supported delivery of FSI-ECD on parent mental health, emotion regulation, and familial violence in high risk families with children aged 6-36 months (n=40) in comparison to control families (n=40) who receive standard care. Parental mental health, emotion regulation, household violence, and parenting practices will be assessed at baseline, post-intervention and 6-month follow-up. Study investigators hypothesize that (a) the effects of the FSI-ECD will be comparable to results observed with vulnerable families in Rwanda; (b) digital tools will be feasible and acceptable to CHWs and supervisors.
Aim 3. Leverage well-established relationships and government partners to strengthen capacity for mHealth research and quality healthcare delivery in Sierra Leone. Partners include the University of Makeni, the Directorate of Science, Technology and Innovation, and the Ministry of Health and Sanitation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FSI-ECD | Experimental | Behavioral: Family Strengthening Intervention for Early Childhood DevelopmentThe Family Strengthening Intervention for Early Childhood Development (FSI-ECD) is an evidence-based home-visiting behavioral intervention for vulnerable families with children aged 6-36 months. The FSI-ECD targets improving parental emotion regulation and parent-child interactions to improve parental mental health and child development outcomes and reduce family violence. The FSI-ECD will be delivered in weekly 90-minute home visiting sessions for 12 consecutive weeks. |
| Control | Other | Other: Community Health Worker RoutineThe control is standard maternal and child health home visiting delivered by community health workers. Families will receive three 90-minute home visiting educational sessions focused on nutrition, hygiene, and post-natal care. |
Who may qualify
- Ages
- 6 months to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Focus Group-User Interface/User Experience (UI/UX) Participants: Aged 18 or older; ability to attend 1-2 sessions (90 minutes per session)
- Family Participants: Families who are (a) a Sierra Leonean household with cohabitating caregivers (e.g., father/mother, mother/grandmother, mother/intimate partner), and child (aged 6-36 months) with both parents aged 18 or older and; (b) one parent scoring at least 62.5 on the Difficulties in Emotion Regulation Scale (DERS). The DERS cut-off score has been used successfully as a risk assessment screening tool in our prior and ongoing studies in Sierra Leone. Sierra Leonean caregivers scoring above this threshold on the DERS have reported significantly higher levels of severe physical punishment with their children as well as intimate partner violence. Both parents must agree to attend FSI-ECD sessions. If enrolled families have more than one child aged 6-36 months, we will include all eligible children as study participants.
- Community Health Worker Participants: CHWs who are 18 years or older and who are assigned to the Peripheral Health Unit that provides health services in one of our target communities.
- Community Health Worker Supervisor Participants: Supervisors are 18 years or older and oversee CHWs providing maternal and child health services
Key exclusion criteria (4 listed)
- Focus Group-User Interface/User Experience (UI/UX) Participants: Individuals younger than age 18 and individuals who do not meet inclusion criteria.
- Family Participants: Families who do not meet all inclusion criteria and/or who are experiencing active family crises (e.g., current suicidality or psychosis, cognitive impairment, ongoing divorce process).
- Community Health Worker Participants: Individuals under age 18 cannot be recruited to work as a CHW.
- Community Health Worker Supervisor Participants: Individuals under age 18.
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 |
|---|---|---|
| Family Strengthening Intervention for Early Childhood DevelopmentThe Family Strengthening Intervention for Early Childhood Development (FSI-ECD) is an evidence-based home-visiting behavioral intervention for vulnerable families with children aged 6-36 months. The FSI-ECD targets improving parental emotion regulation and parent-child interactions to improve parental mental health and child development outcomes and reduce family violence. FSI-ECD compromises five core components delivered in 12 modules delivered in weekly sessions via active coaching by community health workers. Core components include coaching on: a) nutrition, health and hygiene; b) early stimulation and playful parenting; c) building resilience and coping skills; d) building problem-solving skills; and d) building emotion regulation and conflict resolution skills. | Behavioural | FSI-ECD |
| Community Health Worker RoutineStandard CHW care involves three home visiting sessions delivered to families following childbirth with weekly supervision via phone or face-to-face. Topics of home visiting sessions include: skilled post-natal care for mothers, early initiation of breastfeeding and exclusive breastfeeding practices, adequate nutrition, immunization services and timely use of these services, hand washing and hygiene practices (including waste disposal and food hygiene), building the capacity of family members to appropriately take care of newborns and children under age 5, and building the capacity of family members to recognize and act on postnatal danger signs for newborns, mothers, and children under 5. CHWs also conduct screenings for acute malnutrition and growth monitoring to identify early referrals, and they can provide family planning methods, deworming tablets and other vitamins for acute malnutrition, dehydration, and anti-malaria treatment. Each home-visiting session lasts about 60 minutes. | Other | Control |
Primary outcome
Feasibility as assessed through the John Hopkins Implementation and Dissemination Science Scale
Time frame: Immediately after the intervention
Feasibility of mHealth tool implementation to support FSI-ECD delivery will be assessed via a Dissemination and Implementation measures developed by the John Hopkins Bloomberg School of Health. This is a 20-item self-report measure and items are scored on a 4-point Likert scale: 1=not at all, 2=a little bit, 3=a moderate amount, 4=a lot.
Acceptability as assessed through the John Hopkins Implementation and Dissemination Science Scale
Time frame: Immediately after the intervention
Acceptability of mHealth tool implementation to support FSI-ECD delivery will be assessed via a Dissemination and Implementation measures developed by the John Hopkins Bloomberg School of Health. This is a 10-item self-report measure and items are scored on a 4-point Likert scale: 1=not at all, 2=a little bit, 3=a moderate amount, 4=a lot.
6 secondary outcomes
Difficulties in Emotion Regulation Scale (DERS)
Time frame: Baseline, immediately after the intervention, and 3-months after the intervention
Conflict Tactics Scale-2 (CTS-2)
Time frame: Baseline, immediately after the intervention, and 3-months after the intervention
Home Observation for Measurement of the Environment (HOME)
Time frame: Baseline, immediately after the intervention, and 3-months after the intervention
Observation of Mother-Child Interaction (OMCI)
Time frame: Baseline, immediately after the intervention, and 3-months after the intervention
Hopkins Symptom Checklist (HSCL)
Time frame: Baseline, immediately after the intervention and 3-months after the intervention
Post-traumatic Stress Disorder Civilian Checklist
Time frame: Baseline, immediately after the intervention and 3-months after the intervention
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 18 Nov 2023.
- Derived from this study: PubMed 33528371Desrosiers A, Schafer C, Esliker R, Jambai M, Betancourt T. mHealth-Supported Delivery of an Evidence-Based Family Home-Visiting Intervention in Sierra Leone: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2021 Feb 2;10(2):e25443. doi: 10.2196/25443.
- Individual participant dataSharing planned: Yes. Data sharing will be in accordance with the NIH Data Sharing Policy and Implementation Guidance and more specifically the "Data Sharing Expectations for National Institute of Mental Health (NIMH)-funded Clinical Trials". The data generated in this study will be entered into the NIMH Data Archive as required and prescribed by the Notice of Award as well as presented at national and/or international conferences and published in a timely fashion. All final peer-reviewed manuscripts that arise from this proposal will be submitted to the digital archive PubMed Central. Published data will be available in print or electronically from publishers, subject to subscription or printing charges. Research data that document, support and validate research findings will be made available after the main findings from the final research data set have been accepted for publication.
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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.
Alethea Desrosiers, PhD principal investigator
Boston College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Strengthening Intervention for Early Childhood Development and Community Health Worker Routine in people with Parent-Child Relations and Behavioral Intervention, run by Boston College at 1 site in Sierra Leone.
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 4 inclusion and 4 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 18 Nov 2023. 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 Sierra Leone. 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?
Feasibility as assessed through the John Hopkins Implementation and Dissemination Science Scale (time frame: Immediately after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04481399, which also lists 1 linked publication.
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 18 Nov 2023.