Comparison GroupSMARTNCT03081195

SMART Africa (Strengthening Mental Health Research and Training)

A study testing MFG in people with Comparison Group and Multiple Family Groups by Parent Peers, run by Washington University School of Medicine at 4 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this research study is to examine the implementation of and outcomes associated with an evidence-based practice (EBP), specifically Multiple Family Group (MFG) targeting youth disruptive behavior challenges and success, through a scale up intervention study in Uganda, and two pilot studies that will… Read more about this study

Who is it for?: Ages 8 to 99 years
Conditions the study is for: Comparison Group, Multiple Family Groups by Parent Peers, Multiple Family Groups by Community Health Workers
What is being tested?: MFG
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3,117 participants
Where: 4 sitesin 4 countries
Study dates: 6 Oct 2017to 31 May 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 8 to 99 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Inclusion criteria for caregiver/child dyads:
Adult caregiver of a child in primary school, grades two through 7, ages 8 to 13 years
Adult caregiver willing to consent and available for research and intervention activities
Child between the ages 8 to 13 or in primary school (grades two through seven) who is screened for ODD or CD as measured by the Disruptive Behavior Disorder Rating Scale, Impairment Scale, and Iowa Conners Scale.
Child willing to assent.
Caregivers of children who agree to be trained to provide support to families.
Lay paraprofessionals who work within primary care settings.
Directors who oversee schools where the proposed intervention will have been tested.

Who cannot join

Exclusion criteria for caregiver/child dyads:
Lack of understanding of study and study procedures as determined by the research team
Child or caregiver refusal to participate
Refusal to participate
Refusal to participate
Refusal to participate

Trial locations and contacts

4 sites in 4 countries.

Country

City, postcode or hospital

4 sites in 4 countries

United States1 site

Washington University in St. Louis
St Louis, Missouri, 63130

Other trials in United States

Ghana1 site

University of Ghana
Accra

Other trials in Ghana

Kenya1 site

University of Nairobi
Nairobi

Other trials in Kenya

Uganda1 site

Reach the Youth Uganda
Masaka

Other trials in Uganda

About this study

Official title: SMART Africa: Addressing African Youth Mental Health by Scaling Family and Community-Level EBPs

Read the detailed description

A longitudinal experimental mixed methods effectiveness-implementation hybrid research design will be employed. The study will be conducted across thirty primary schools representing both semi-urban and rural communities. We expect to involve 3,000 youth (in primary schools grades 2 through 7; 8 to 13 years) and their adult caregivers (3,000) in Uganda, 180 youth and their caregivers (180) in Ghana, and 180 youth and their caregivers (180) in Kenya.

Schools will be randomly assigned to 3 study conditions: 1) MFG-delivered by trained family peers; 2) MFG-delivered by community health workers (school health education program coordinators in Ghana); or, 3) Comparison: mental health and school support materials (e.g., books, uniforms). Data will be collected at baseline, 8 and 16 weeks, and 6 months follow-up (10 months from baseline).

More specifically the objectives of this study are:

Primary objectives

To examine short- and long-term outcomes associated with the MFG. Hypothesis: Children in the treatment groups (MFG) will improve significantly more compared to those in the comparison (usual care) group.
To examine how systematic variations in the delivery of an evidence-based MFG program impacts outcomes for children with behavioral difficulties and their caregivers in each country context. Hypothesis: Children who participate in MFG with their families will display significantly reduced conduct difficulties and increased functioning over time compared to those involved in comparison condition. We expect that parent peers - compared to community health workers - will evidence significantly more success engaging families to attend MFG sessions, thus, children in the MFG-parent peer delivered condition will evidence the great improvement relative to the other two study conditions. Secondary objectives
To compare the uptake and implementation of MFGs by trained existing family peers and community outreach health workers. Hypothesis: Given the level of training that community outreach health workers have received prior to the study as part of their regular professional training, they will evidence higher fidelity initially, yet with training and ongoing supervision, we expect these differences to decrease over time.
To examine multi-level (state/government, NGOs, families, schools, communities) influences on the uptake, implementation, effectiveness and sustainability of EBPs that address serious child disruptive behavioral challenges.

Conditions: Comparison Group, Multiple Family Groups by Parent Peers, Multiple Family Groups by Community Health Workers
Being tested: MFG
Keywords: child behavior, intervention, multiple family group, Sub Saharan Africa, caregivers
Medical subject headings: Child Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MFGBehavioural
Also called 4Rs and 2Ss, Amaka Amasanyufu (Happy Families in Luganda-Uganda), Dang-Malgu (Family Togetherness in Dagbani-Ghana)
The MFG is a series of weekly meetings guided by a protocol.Over the course of 16 weeks, groups are held weekly and are facilitated by trained and supervised group leaders (in this case either parent peers or community health outreach workers). Groups can consist of up to 20 families involving adult caregivers and all children over six years of age in the family. The protocols have been designed to provide opportunities during each session to directly apply content to the realities of family life, emergent cultural and values perspectives, as well as tailor messages to age of child. Redundancy for missed appointments and opportunities for reinforcement is built in. We aim for families to attend at least 8 meetings or more (out of 16 sessions in total), as findings suggests this dose is needed to reduce child conduct problems and the majority of families reach this goal.

Study groups in NCT03081195
Study group	Role	What they receive
MFG-delivered by trained family peers	Experimental	MFG delivered by trained parent peers drawn from local school planning councils: 10 schools; 60 parent peers (6 per school x 10); 1,000 children and adult caregivers; children screened to evidence serious emerging and clinically significant DBDs Receives: Behavioral: MFG
MFG-delivered by CHWs	Experimental	MFG delivered by community health workers (CHW) drawn from local primary care clinics: 10 schools; 60 community health workers (6 assigned to children per school x 10); 1,000 children and adult caregivers; children screened to evidence serious emerging and clinically significant DBDs Receives: Behavioral: MFG
Bolstered care	No intervention	Comparison (Bolstered care): Mental health wellness materials and educational supports (e.g. books, uniforms) 10 schools; 1,000 children and adult caregivers; children screened to evidence serious emerging and clinically significant DBDs

What is being measured

The primary outcome is the main question the study is designed to answer.

Child disruptive behavior
Change in disruptive behavior will be measured by Iowa Connors
Measured: baseline, 8 weeks, 16 weeks, 6 months
Child impairment
Change in disruptive behavior will be measured Impairment scale
Measured: baseline, 8 weeks, 16 weeks, 6 months

Secondary outcomes (13)

Implementation and Feasibility
implementation and feasibility checklist measures
Measured: 8 weeks, 16 weeks, 6 months
Fidelity
MFG Intervention Fidelity Assessment measures
Measured: end of session at week 1, week 2, week 3, week 4, week 6, week 7, week 8, week 9, week 10, week 11, week 12, week 13, week 14, week 15, week 16
Sustainability
Program Sustainability Assessment Tool
Measured: 8 weeks, 16 weeks, 6 months
Implementation process
Metropolitan Area Child Study process measure
Measured: 8 weeks, 16 weeks, 6 months
Parenting
Change in parenting will be measured by Alabama Parenting questionnaire
Measured: baseline, 8 weeks, 16 weeks, 6 months
Social support
Improvement in social support will be measured by Multidimensional scale of perceived social support -modified
Measured: baseline, 8 weeks, 16 weeks, 6 months
Caregiver depression
Change in caregiver depression will be measured by Center for Epidemiologic Studies Short Depression Scale
Measured: baseline, 8 weeks, 16 weeks, 6 months
Caregiver mental health
Change in caregiver mental health will be measured by Brief Symptom Checklist
Measured: baseline, 8 weeks, 16 weeks, 6 months
Caregiver stress
Change in caregiver stress will be measured by parent stress index short form
Measured: baseline, 8 weeks, 16 weeks, 6 months
Child mental health
Change in Child mental health will be measured by Strengths and Difficulties questionnaire
Measured: baseline, 8 weeks, 16 weeks, 6 months
Child self-concept
Change in child self-concept will be measured by tennessee self-concept
Measured: baseline, 8 weeks, 16 weeks, 6 months
Child depression
Change in child depression will be measured by child depression scale
Measured: baseline, 8 weeks, 16 weeks, 6 months
Family relations
Change in family relations will be measured by Family Relations and Cohesion scale
Measured: baseline, 8 weeks, 16 weeks, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Oct 201731 May 2021

First posted16 Mar 2017
Study start6 Oct 2017
Primary completion31 May 2021
Study completion31 May 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Comparison GroupStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Schools will be randomly assigned to 3 study conditions: 1) MFG-delivered by trained family peers; 2) MFG-delivered by community health workers; or, 3) Comparison: Mental health and school support materials (books).
Masking: Single blind
Who is masked: Participant
Enrolment: 3,117 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03081195
Sponsor's protocol ID: U19MH110001-011
Other IDs: U19MH110001
Acronym: SMART
Status last verified: Nov 2024
First submitted: 23 Feb 2017
Last updated: 25 Nov 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: There will be no individual participant data that will be shared.

Publications

Ssewamala FM, Brathwaite R, Sensoy Bahar O, Namatovu P, Neilands TB, Kiyingi J, Huang KY, McKay MM. The Post-intervention Impact of Amaka Amasanyufu on Behavioral and Mental Health Functioning of Children and Adolescents in Low-Resource Communities in Uganda: Analysis of a Cluster-Randomized Trial From the SMART Africa-Uganda Study (2016-2022). J Adolesc Health. 2023 May;72(5S):S3-S10. doi: 10.1016/j.jadohealth.2022.09.035.
PubMed 37062581
Brathwaite R, Sensoy Bahar O, Mutumba M, Byansi W, Namatovu P, Namuwonge F, Neilands TB, McKay MM, Hoagwood KE, Ssewamala FM. Short-Term Impact of "Amaka Amasanyufu" Multiple Family Group Intervention on Mental Health Functioning of Children With Disruptive Behavior Disorders in Uganda. J Am Acad Child Adolesc Psychiatry. 2023 Jul;62(7):777-790. doi: 10.1016/j.jaac.2022.12.028. Epub 2023 Mar 8.
PubMed 36898607
Brathwaite R, Ssewamala FM, Sensoy Bahar O, McKay MM, Neilands TB, Namatovu P, Kiyingi J, Zmachinski L, Nabayinda J, Huang KY, Kivumbi A, Bhana A, Mwebembezi A, Petersen I, Hoagwood K; SMART Africa - Uganda Field Team. The longitudinal impact of an evidence-based multiple family group intervention (Amaka Amasanyufu) on oppositional defiant disorder and impaired functioning among children in Uganda: analysis of a cluster randomized trial from the SMART Africa-Uganda scale-up study (2016-2022). J Child Psychol Psychiatry. 2022 Nov;63(11):1252-1260. doi: 10.1111/jcpp.13566. Epub 2022 Jan 6.
PubMed 34989404
Asampong E, Ibrahim A, Sensoy-Bahar O, Kumbelim K, Yaro PB, McKay MM, Ssewamala FM. Adaptation and Implementation of the Multiple-Family Group Intervention in Ghana. Psychiatr Serv. 2021 May 1;72(5):571-577. doi: 10.1176/appi.ps.201900626. Epub 2021 Jan 12.
PubMed 33430647
Ssewamala FM, Sensoy Bahar O, McKay MM, Hoagwood K, Huang KY, Pringle B. Strengthening mental health and research training in Sub-Saharan Africa (SMART Africa): Uganda study protocol. Trials. 2018 Aug 6;19(1):423. doi: 10.1186/s13063-018-2751-z.
PubMed 30081967

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Comparison Group trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: SMART Africa: Addressing African Youth Mental Health by Scaling Family and Community-Level EBPs
ClinicalTrials.gov ID: NCT03081195
Acronym / sponsor ID: SMART / U19MH110001-011
Conditions: Comparison Group, Multiple Family Groups by Parent Peers, Multiple Family Groups by Community Health Workers
Keywords: child behavior, intervention, multiple family group, Sub Saharan Africa, caregivers
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,117 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Collaborators: University of Ghana, University of Nairobi, Reach the Youth Uganda, New York University, National Institute of Mental Health (NIMH)
Study start: 6 Oct 2017 (actual)
Primary completion: 31 May 2021 (actual)
Study completion: 31 May 2021 (actual)
First posted: 16 Mar 2017 (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.

Detailed description

More specifically the objectives of this study are:

Primary objectives

To examine short- and long-term outcomes associated with the MFG. Hypothesis: Children in the treatment groups (MFG) will improve significantly more compared to those in the comparison (usual care) group.
To examine how systematic variations in the delivery of an evidence-based MFG program impacts outcomes for children with behavioral difficulties and their caregivers in each country context. Hypothesis: Children who participate in MFG with their families will display significantly reduced conduct difficulties and increased functioning over time compared to those involved in comparison condition. We expect that parent peers - compared to community health workers - will evidence significantly more success engaging families to attend MFG sessions, thus, children in the MFG-parent peer delivered condition will evidence the great improvement relative to the other two study conditions. Secondary objectives
To compare the uptake and implementation of MFGs by trained existing family peers and community outreach health workers. Hypothesis: Given the level of training that community outreach health workers have received prior to the study as part of their regular professional training, they will evidence higher fidelity initially, yet with training and ongoing supervision, we expect these differences to decrease over time.
To examine multi-level (state/government, NGOs, families, schools, communities) influences on the uptake, implementation, effectiveness and sustainability of EBPs that address serious child disruptive behavioral challenges.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3
Model description: Schools will be randomly assigned to 3 study conditions: 1) MFG-delivered by trained family peers; 2) MFG-delivered by community health workers; or, 3) Comparison: Mental health and school support materials (books).

Arm	Type	Receives
MFG-delivered by trained family peers	Experimental	Behavioral: MFGMFG delivered by trained parent peers drawn from local school planning councils: 10 schools; 60 parent peers (6 per school x 10); 1,000 children and adult caregivers; children screened to evidence serious emerging and clinically significant DBDs
MFG-delivered by CHWs	Experimental	Behavioral: MFGMFG delivered by community health workers (CHW) drawn from local primary care clinics: 10 schools; 60 community health workers (6 assigned to children per school x 10); 1,000 children and adult caregivers; children screened to evidence serious emerging and clinically significant DBDs
Bolstered care	No intervention	–Comparison (Bolstered care): Mental health wellness materials and educational supports (e.g. books, uniforms) 10 schools; 1,000 children and adult caregivers; children screened to evidence serious emerging and clinically significant DBDs

Who may qualify

Ages: 8 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (8 listed)

Inclusion criteria for caregiver/child dyads:
Adult caregiver of a child in primary school, grades two through 7, ages 8 to 13 years
Adult caregiver willing to consent and available for research and intervention activities
Child between the ages 8 to 13 or in primary school (grades two through seven) who is screened for ODD or CD as measured by the Disruptive Behavior Disorder Rating Scale, Impairment Scale, and Iowa Conners Scale.
Child willing to assent.

Key exclusion criteria (6 listed)

Exclusion criteria for caregiver/child dyads:
Lack of understanding of study and study procedures as determined by the research team
Child or caregiver refusal to participate
Refusal to participate
Refusal to participate

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
MFGAlso: 4Rs and 2Ss, Amaka Amasanyufu (Happy Families in Luganda-Uganda), Dang-Malgu (Family Togetherness in Dagbani-Ghana)The MFG is a series of weekly meetings guided by a protocol.Over the course of 16 weeks, groups are held weekly and are facilitated by trained and supervised group leaders (in this case either parent peers or community health outreach workers). Groups can consist of up to 20 families involving adult caregivers and all children over six years of age in the family. The protocols have been designed to provide opportunities during each session to directly apply content to the realities of family life, emergent cultural and values perspectives, as well as tailor messages to age of child. Redundancy for missed appointments and opportunities for reinforcement is built in. We aim for families to attend at least 8 meetings or more (out of 16 sessions in total), as findings suggests this dose is needed to reduce child conduct problems and the majority of families reach this goal.	Behavioural	MFG-delivered by CHWs, MFG-delivered by trained family peers

Primary outcome

Child disruptive behavior
Time frame: baseline, 8 weeks, 16 weeks, 6 months
Change in disruptive behavior will be measured by Iowa Connors
Child impairment
Time frame: baseline, 8 weeks, 16 weeks, 6 months
Change in disruptive behavior will be measured Impairment scale

13 secondary outcomes

Implementation and Feasibility
Time frame: 8 weeks, 16 weeks, 6 months
Fidelity
Time frame: end of session at week 1, week 2, week 3, week 4, week 6, week 7, week 8, week 9, week 10, week 11, week 12, week 13, week 14, week 15, week 16
Sustainability
Time frame: 8 weeks, 16 weeks, 6 months
Implementation process
Time frame: 8 weeks, 16 weeks, 6 months
Parenting
Time frame: baseline, 8 weeks, 16 weeks, 6 months
Social support
Time frame: baseline, 8 weeks, 16 weeks, 6 months
Caregiver depression
Time frame: baseline, 8 weeks, 16 weeks, 6 months
Caregiver mental health
Time frame: baseline, 8 weeks, 16 weeks, 6 months
Caregiver stress
Time frame: baseline, 8 weeks, 16 weeks, 6 months
Child mental health
Time frame: baseline, 8 weeks, 16 weeks, 6 months
Child self-concept
Time frame: baseline, 8 weeks, 16 weeks, 6 months
Child depression
Time frame: baseline, 8 weeks, 16 weeks, 6 months
Family relations
Time frame: baseline, 8 weeks, 16 weeks, 6 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 25 Nov 2024.
Derived from this study: PubMed 37062581Ssewamala FM, Brathwaite R, Sensoy Bahar O, Namatovu P, Neilands TB, Kiyingi J, Huang KY, McKay MM. The Post-intervention Impact of Amaka Amasanyufu on Behavioral and Mental Health Functioning of Children and Adolescents in Low-Resource Communities in Uganda: Analysis of a Cluster-Randomized Trial From the SMART Africa-Uganda Study (2016-2022). J Adolesc Health. 2023 May;72(5S):S3-S10. doi: 10.1016/j.jadohealth.2022.09.035.
Derived from this study: PubMed 36898607Brathwaite R, Sensoy Bahar O, Mutumba M, Byansi W, Namatovu P, Namuwonge F, Neilands TB, McKay MM, Hoagwood KE, Ssewamala FM. Short-Term Impact of "Amaka Amasanyufu" Multiple Family Group Intervention on Mental Health Functioning of Children With Disruptive Behavior Disorders in Uganda. J Am Acad Child Adolesc Psychiatry. 2023 Jul;62(7):777-790. doi: 10.1016/j.jaac.2022.12.028. Epub 2023 Mar 8.
Derived from this study: PubMed 34989404Brathwaite R, Ssewamala FM, Sensoy Bahar O, McKay MM, Neilands TB, Namatovu P, Kiyingi J, Zmachinski L, Nabayinda J, Huang KY, Kivumbi A, Bhana A, Mwebembezi A, Petersen I, Hoagwood K; SMART Africa - Uganda Field Team. The longitudinal impact of an evidence-based multiple family group intervention (Amaka Amasanyufu) on oppositional defiant disorder and impaired functioning among children in Uganda: analysis of a cluster randomized trial from the SMART Africa-Uganda scale-up study (2016-2022). J Child Psychol Psychiatry. 2022 Nov;63(11):1252-1260. doi: 10.1111/jcpp.13566. Epub 2022 Jan 6.
Derived from this study: PubMed 33430647Asampong E, Ibrahim A, Sensoy-Bahar O, Kumbelim K, Yaro PB, McKay MM, Ssewamala FM. Adaptation and Implementation of the Multiple-Family Group Intervention in Ghana. Psychiatr Serv. 2021 May 1;72(5):571-577. doi: 10.1176/appi.ps.201900626. Epub 2021 Jan 12.
Derived from this study: PubMed 30081967Ssewamala FM, Sensoy Bahar O, McKay MM, Hoagwood K, Huang KY, Pringle B. Strengthening mental health and research training in Sub-Saharan Africa (SMART Africa): Uganda study protocol. Trials. 2018 Aug 6;19(1):423. doi: 10.1186/s13063-018-2751-z.
Individual participant dataSharing planned: No. There will be no individual participant data that will be shared.

Related trials for Comparison Group

Not yet recruitingPhase 1
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Healthy, Renal Impairment
RecruitingPhase 3
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Active, not recruitingPhase 3
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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.

Mary McKay, PhD principal investigator

Washington University School of Medicine

Fred Ssewamala, PhD principal investigator

Washington University School of Medicine

4 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing MFG in people with Comparison Group and Multiple Family Groups by Parent Peers, run by Washington University School of Medicine at 4 sites in 4 countries.

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 8 inclusion and 6 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 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, Ghana, Kenya, Uganda. 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?

Child disruptive behavior (time frame: baseline, 8 weeks, 16 weeks, 6 months). 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 NCT03081195, which also lists 5 linked publications.

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 25 Nov 2024.