ParentingNCT03975530
Piloting a Precision Approach to Home Visiting
A study testing Precision Family Spirit and Standard Family Spirit in people with Parenting and Mother-Child Relations, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial summary
The proposed study will be a randomized pilot study. Family Spirit home-visiting sites from the Inter-Tribal Council of Michigan (ITC of MI) will be selected based on comparability and randomized to provide either standard Family Spirit or precision Family Spirit to their clients. Read more about this study
- Who is it for?
- Ages 14 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Parenting, Mother-Child Relations, Child Development
- What is being tested?
- Precision Family Spirit and Standard Family Spirit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2019to 18 Dec 2020
- 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 14 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Prenatal or postpartum females who have a baby no older than 2 months old
- At least 14 years of age at time of conception
- Receiving Family Spirit services through ITC of MI
Who cannot join
- < 13 years old at time of conception of index pregnancy
- Index child is older than 2 months of age
- Inability to participate in full intervention or evaluation
Trial locations and contacts
1 site in 1 country.
United States1 site
Inter-Tribal Council of Michigan (ITC of MI)
Sault Ste. Marie, Michigan, 49783
About this study
The proposed study will be a randomized pilot study. Family Spirit home-visiting sites from the Inter-Tribal Council of Michigan (ITC of MI) will be selected based on comparability and randomized to provide either standard Family Spirit or precision Family Spirit to their clients. Sites in both groups will use an electronic platform to support implementation. The investigators will select four sites and randomize two of them to standard Family Spirit and two to precision Family Spirit. Sites will be matched based on annual volume of clients served and geographic similarity (i.e. urban vs. rural). All participating sites will be trained in the electronic implementation support platform. The two sites randomized to provide the precision approach will receive additional training on how to provide it.
In each site, all new clients who are prenatal or up to 2-months postpartum will be offered participation in the study. The study will then follow them until 12 months postpartum and measure outcomes during this time (see measurement table below). Qualitative interviews with precision participants will be done at 6 and 12 months postpartum. Focus group discussions with home visitors will also be completed during regular study team meetings. Analysis of study instruments (basic psychometrics based on baseline and end line data) and preliminary differences between the sites on Aim 3 and 4 outcomes will be done in December 2019 assuming the investigators have achieved their estimated sample size with enough retention for 6-months post enrollment. Dissemination of results will be done upon completion of the analysis.
Read the detailed description
Home visiting programs provide critical support to families and young children to promote healthy development and reduce health disparities. Decades of research has yielded a robust evidence base supporting their effectiveness and impact on maternal and child outcomes. In 2010, the importance of these interventions was recognized nationally with the authorization of $1.5 billion to fund Maternal, Infant, and Early Childhood Home Visiting (MIECHV) across states and tribes. MIECHV was most recently reauthorized and funded for five years in early 2018. There are now 21 evidence-based early childhood home visiting models nationwide, all of which have evidence from multiple randomized controlled trials, favorable impacts on primary and secondary outcomes, and sustained impacts of the intervention over time.
Despite robust evidence of early childhood home-visiting effectiveness, replication and scale-up beyond the context of research has been challenging. Improving program retention, enhancing program content to address families' unique and often complex needs, and increasing fidelity have been identified as priority areas for further research. While building the evidence base for home-visiting programs, researchers necessarily took a "one-size-fits-all" approach - designing programs that are often lengthy (2-3 years long) and include standard lesson sequencing and dosing delivered in the same way to all participants. However, mothers and children do not all need the same program content or dosages. A one-size-fits-all approach fails to address maternal-child need and has led to differential outcomes across studies and populations, indicating that the promise of home-visiting to improve health has yet to be fully realized.
The need for home-visiting programs that can address maternal-child diverse and emergent needs and improve client reach and retention, while maintaining fidelity to the active ingredients of evidence-based home-visiting programs, is at the forefront of research and practice-based dialogue in the US. Recent qualitative research on high- and low-retention sites within the Nurse Family Partnership network showed that nurses in high retention sites were more collaborative with families and adapted the program to align more with families' needs compared to nurses in low retention sites. Based on these findings, Ingoldsby and colleagues used principals of motivational interviewing to provide nurses with more explicit control over the visit schedule and content to families. When they compared retention rates for nurses trained in motivational interviewing to rates for nurses trained in the standard approach, they found retention rates were significantly better when nurses had more flexibility in service delivery.
For the past several years, the Johns Hopkins Center for American Indian Health (CAIH) at Johns Hopkins University has partnered with the Annie E. Casey Foundation for formative work to develop a precision public health approach to the Family Spirit home-visiting program. Leveraging CAIH's existing evidence-based home-visiting program, Family Spirit, the goal of this project was to enhance the Family Spirit model to aid home visitors in tailoring content to meet families' specific needs and continuously monitor clients' emergent issues or improvements so that home-visiting education remains responsive, relevant, and feasible. This precision approach and corresponding implementation support have been developed. The current study will be a pilot study of the precision approach compared to the standard of care. In the standard of care, families receive regular home visits, delivered in the same sequence for up to 39 months. In the precision approach, there is a core set of lessons that every mother will get, but then additional lessons will be added based on maternal or child need. For example, if a mother is a first-time mom, they will get additional baby care lessons that are included in the standard Family Spirit curriculum but may not be relevant for moms with previous children.
- Conditions
- Parenting, Mother-Child Relations, Child Development
- Being tested
- Precision Family Spirit, Standard Family Spirit
- Keywords
- Home visiting interventions, American Indian, Community based participatory research, Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Precision Family SpiritBehavioural
Family Spirit home-visiting sites from the Inter-Tribal Council of Michigan (ITC of MI) will be selected based on comparability and randomized to provide either Standard Family Spirit or Precision Family Spirit to their clients. Both groups will receive educational Family Spirit lessons. Each lesson will take about 60 minutes. Participants will receive a customized version of Family Spirit that is unique to your circumstances. The two sites randomized to provide the Precision approach will receive additional training on how to provide it.
Standard Family SpiritBehavioural
Family Spirit home-visiting sites from the Inter-Tribal Council of Michigan (ITC of MI) will be selected based on comparability and randomized to provide either Standard Family Spirit or Precision Family Spirit to their clients. The investigators will select four sites and randomize two of them to Standard Family Spirit and two to Precision Family Spirit.Both groups will receive educational Family Spirit lessons. Each lesson will take about 60 minutes. Participants will receive Family Spirit lessons based on a standard program schedule.
| Study group | Role | What they receive |
|---|---|---|
| Precision Family Spirit | Experimental | Family Spirit home-visiting sites from the Inter-Tribal Council of Michigan (ITC of MI) will be selected based on comparability and randomized to provide either Standard Family Spirit or Precision Family Spirit to their clients. The investigators will select four sites and randomize two of them to Standard Family Spirit and two to Precision Family Spirit. Both groups will receive educational Family Spirit lessons. Each lesson will take about 60 minutes. Participants will receive a customized version of Family Spirit that is unique to your circumstances. The two sites randomized to provide the Precision approach will receive additional training on how to provide it. At 6 months postpartum, and upon completion of the intervention, participants in the treatment group will be asked to participate in brief semi-structured phone interviews. Receives: Behavioral: Precision Family Spirit |
| Standard Family Spirit | Active comparator | Family Spirit home-visiting sites from the Inter-Tribal Council of Michigan (ITC of MI) will be selected based on comparability and randomized to provide either Standard Family Spirit or Precision Family Spirit to their clients. The investigators will select four sites and randomize two of them to Standard Family Spirit and two to Precision Family Spirit. Both groups will receive educational Family Spirit lessons. Each lesson will take about 60 minutes. Participants will receive Family Spirit lessons based on a standard program schedule. Receives: Behavioral: Standard Family Spirit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the home-visiting program from the perspective of mothers enrolled
We will use the acceptability subscale from the Applied Mental Health Research group's Implementation Measure:
Haroz, E. E., Bolton, P., Nguyen, A. J., Lee, C., Bogdanov, S., Bass, J., ... \& Murray, L. (2019). Measuring implementation in global mental health: validation of a pragmatic implementation science measure in eastern Ukraine using an experimental vignette design. BMC health services research, 19(1), 262.
The acceptability subscale has 17 items and is scored as an average across items with a range of 0 being lowest acceptability to 3 being highest acceptability.
Measured: Baseline, 2-months postpartum, 6-months postpartum, 12-months postpartum
Retention in the home-visiting programs
We will compare the proportion of mothers who enroll and are still enrolled at the measurement timepoint across the study arms.
Measured: 2-months postpartum, 6-months postpartum, 12-months postpartum
Participant satisfaction
We will use an adapted version of the satisfaction scale used in the final Family Spirit trial:
Barlow A, Mullany B, Neault N, et al. Paraprofessional Delivered, Home-Visiting Intervention for American Indian Teen Mothers and Children: Three-Year Outcomes from a Randomized Controlled Trial. American Journal of Psychiatry. 2015; 172(2):154-162. doi: 10.1176/appi.ajp.2014.14030332.
For the purposes of this study, we will focus on the seven items that aimed to measure satisfaction with the skills and competencies Family Spirit aims to instill in parents (e.g., "I learned helpful skills" or "Because of what I've learned in the program, I feel that my child is healthier"). The satisfaction items are scored 0 "Strongly Disagree" to 5 "Strongly Agree," and higher total scores correlate with higher levels of satisfaction.
Measured: 6-months postpartum, 12-months postpartum
Adherence
We will compare the percent of prescribed visits completed at 6- and 12-months across study arms.
Measured: Study enrollment through study completion, an average of 1 year
Home visitor-participant relationship
We will use the shortened version of the Working Alliance Inventory (WAI). It has 12 items, and the participant and home visitor each complete their own version of the measure. Possible scores for each item on the WAI ranged from 1 "Never" to 7 "Always" and are summed for a total score. A higher score on the WAI indicates a stronger therapeutic alliance.
Measured: 2-months postpartum, 6-months postpartum, 12-months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start24 Jun 2019
- Primary completion18 Dec 2020
- Study completion18 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ParentingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Inter-Tribal Council of Michigan, Inc.
- Responsible party
- Sponsor
- Investigators
- Emily Haroz, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03975530
- Sponsor's protocol ID
- 9315
- Status last verified
- Jan 2022
- First submitted
- 22 May 2019
- Last updated
- 6 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ingalls A, Rebman P, Martin L, Kushman E, Leonard A, Cisler A, Gschwind I, Brayak A, Amsler AM, Haroz EE. Towards precision home visiting: results at six months postpartum from a randomized pilot implementation trial to assess the feasibility of a precision approach to Family Spirit. BMC Pregnancy Childbirth. 2022 Sep 23;22(1):725. doi: 10.1186/s12884-022-05057-4.
PubMed 36151535Ingalls A, Barlow A, Kushman E, Leonard A, Martin L, Team PFSS, West AL, Neault N, Haroz EE. Precision Family Spirit: a pilot randomized implementation trial of a precision home visiting approach with families in Michigan-trial rationale and study protocol. Pilot Feasibility Stud. 2021 Jan 6;7(1):8. doi: 10.1186/s40814-020-00753-4.
PubMed 33407939
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting a Precision Approach to Home Visiting
- ClinicalTrials.gov ID
- NCT03975530
- Acronym / sponsor ID
- 9315
- Conditions
- Parenting, Mother-Child Relations, Child Development
- Keywords
- Home visiting interventions, American Indian, Community based participatory research, Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Inter-Tribal Council of Michigan, Inc.
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 18 Dec 2020 (actual)
- Study completion
- 18 Dec 2020 (actual)
- First posted
- 5 Jun 2019 (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 study will be a randomized pilot study. Family Spirit home-visiting sites from the Inter-Tribal Council of Michigan (ITC of MI) will be selected based on comparability and randomized to provide either standard Family Spirit or precision Family Spirit to their clients. Sites in both groups will use an electronic platform to support implementation. The investigators will select four sites and randomize two of them to standard Family Spirit and two to precision Family Spirit. Sites will be matched based on annual volume of clients served and geographic similarity (i.e. urban vs. rural). All participating sites will be trained in the electronic implementation support platform. The two sites randomized to provide the precision approach will receive additional training on how to provide it.
In each site, all new clients who are prenatal or up to 2-months postpartum will be offered participation in the study. The study will then follow them until 12 months postpartum and measure outcomes during this time (see measurement table below). Qualitative interviews with precision participants will be done at 6 and 12 months postpartum. Focus group discussions with home visitors will also be completed during regular study team meetings. Analysis of study instruments (basic psychometrics based on baseline and end line data) and preliminary differences between the sites on Aim 3 and 4 outcomes will be done in December 2019 assuming the investigators have achieved their estimated sample size with enough retention for 6-months post enrollment. Dissemination of results will be done upon completion of the analysis.
Detailed description
Home visiting programs provide critical support to families and young children to promote healthy development and reduce health disparities. Decades of research has yielded a robust evidence base supporting their effectiveness and impact on maternal and child outcomes. In 2010, the importance of these interventions was recognized nationally with the authorization of $1.5 billion to fund Maternal, Infant, and Early Childhood Home Visiting (MIECHV) across states and tribes. MIECHV was most recently reauthorized and funded for five years in early 2018. There are now 21 evidence-based early childhood home visiting models nationwide, all of which have evidence from multiple randomized controlled trials, favorable impacts on primary and secondary outcomes, and sustained impacts of the intervention over time.
Despite robust evidence of early childhood home-visiting effectiveness, replication and scale-up beyond the context of research has been challenging. Improving program retention, enhancing program content to address families' unique and often complex needs, and increasing fidelity have been identified as priority areas for further research. While building the evidence base for home-visiting programs, researchers necessarily took a "one-size-fits-all" approach - designing programs that are often lengthy (2-3 years long) and include standard lesson sequencing and dosing delivered in the same way to all participants. However, mothers and children do not all need the same program content or dosages. A one-size-fits-all approach fails to address maternal-child need and has led to differential outcomes across studies and populations, indicating that the promise of home-visiting to improve health has yet to be fully realized.
The need for home-visiting programs that can address maternal-child diverse and emergent needs and improve client reach and retention, while maintaining fidelity to the active ingredients of evidence-based home-visiting programs, is at the forefront of research and practice-based dialogue in the US. Recent qualitative research on high- and low-retention sites within the Nurse Family Partnership network showed that nurses in high retention sites were more collaborative with families and adapted the program to align more with families' needs compared to nurses in low retention sites. Based on these findings, Ingoldsby and colleagues used principals of motivational interviewing to provide nurses with more explicit control over the visit schedule and content to families. When they compared retention rates for nurses trained in motivational interviewing to rates for nurses trained in the standard approach, they found retention rates were significantly better when nurses had more flexibility in service delivery.
For the past several years, the Johns Hopkins Center for American Indian Health (CAIH) at Johns Hopkins University has partnered with the Annie E. Casey Foundation for formative work to develop a precision public health approach to the Family Spirit home-visiting program. Leveraging CAIH's existing evidence-based home-visiting program, Family Spirit, the goal of this project was to enhance the Family Spirit model to aid home visitors in tailoring content to meet families' specific needs and continuously monitor clients' emergent issues or improvements so that home-visiting education remains responsive, relevant, and feasible. This precision approach and corresponding implementation support have been developed. The current study will be a pilot study of the precision approach compared to the standard of care. In the standard of care, families receive regular home visits, delivered in the same sequence for up to 39 months. In the precision approach, there is a core set of lessons that every mother will get, but then additional lessons will be added based on maternal or child need. For example, if a mother is a first-time mom, they will get additional baby care lessons that are included in the standard Family Spirit curriculum but may not be relevant for moms with previous children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Precision Family Spirit | Experimental | Behavioral: Precision Family SpiritFamily Spirit home-visiting sites from the Inter-Tribal Council of Michigan (ITC of MI) will be selected based on comparability and randomized to provide either Standard Family Spirit or Precision Family Spirit to their clients. The investigators will select four sites and randomize two of them to Standard Family Spirit and two to Precision Family Spirit. Both groups will receive educational Family Spirit lessons. Each lesson will take about 60 minutes. Participants will receive a customized version of Family Spirit that is unique to your circumstances. The two sites randomized to provide the Precision approach will receive additional training on how to provide it. At 6 months postpartum, and upon completion of the intervention, participants in the treatment group will be asked to participate in brief semi-structured phone interviews. |
| Standard Family Spirit | Active comparator | Behavioral: Standard Family SpiritFamily Spirit home-visiting sites from the Inter-Tribal Council of Michigan (ITC of MI) will be selected based on comparability and randomized to provide either Standard Family Spirit or Precision Family Spirit to their clients. The investigators will select four sites and randomize two of them to Standard Family Spirit and two to Precision Family Spirit. Both groups will receive educational Family Spirit lessons. Each lesson will take about 60 minutes. Participants will receive Family Spirit lessons based on a standard program schedule. |
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Prenatal or postpartum females who have a baby no older than 2 months old
- At least 14 years of age at time of conception
- Receiving Family Spirit services through ITC of MI
Key exclusion criteria (3 listed)
- < 13 years old at time of conception of index pregnancy
- Index child is older than 2 months of age
- Inability to participate in full intervention or evaluation
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 |
|---|---|---|
| Precision Family SpiritFamily Spirit home-visiting sites from the Inter-Tribal Council of Michigan (ITC of MI) will be selected based on comparability and randomized to provide either Standard Family Spirit or Precision Family Spirit to their clients. Both groups will receive educational Family Spirit lessons. Each lesson will take about 60 minutes. Participants will receive a customized version of Family Spirit that is unique to your circumstances. The two sites randomized to provide the Precision approach will receive additional training on how to provide it. | Behavioural | Precision Family Spirit |
| Standard Family SpiritFamily Spirit home-visiting sites from the Inter-Tribal Council of Michigan (ITC of MI) will be selected based on comparability and randomized to provide either Standard Family Spirit or Precision Family Spirit to their clients. The investigators will select four sites and randomize two of them to Standard Family Spirit and two to Precision Family Spirit.Both groups will receive educational Family Spirit lessons. Each lesson will take about 60 minutes. Participants will receive Family Spirit lessons based on a standard program schedule. | Behavioural | Standard Family Spirit |
Primary outcome
Acceptability of the home-visiting program from the perspective of mothers enrolled
Time frame: Baseline, 2-months postpartum, 6-months postpartum, 12-months postpartum
We will use the acceptability subscale from the Applied Mental Health Research group's Implementation Measure: Haroz, E. E., Bolton, P., Nguyen, A. J., Lee, C., Bogdanov, S., Bass, J., ... \& Murray, L. (2019). Measuring implementation in global mental health: validation of a pragmatic implementation science measure in eastern Ukraine using an experimental vignette design. BMC health services research, 19(1), 262. The acceptability subscale has 17 items and is scored as an average across items with a range of 0 being lowest acceptability to 3 being highest acceptability.
Retention in the home-visiting programs
Time frame: 2-months postpartum, 6-months postpartum, 12-months postpartum
We will compare the proportion of mothers who enroll and are still enrolled at the measurement timepoint across the study arms.
Participant satisfaction
Time frame: 6-months postpartum, 12-months postpartum
We will use an adapted version of the satisfaction scale used in the final Family Spirit trial: Barlow A, Mullany B, Neault N, et al. Paraprofessional Delivered, Home-Visiting Intervention for American Indian Teen Mothers and Children: Three-Year Outcomes from a Randomized Controlled Trial. American Journal of Psychiatry. 2015; 172(2):154-162. doi: 10.1176/appi.ajp.2014.14030332. For the purposes of this study, we will focus on the seven items that aimed to measure satisfaction with the skills and competencies Family Spirit aims to instill in parents (e.g., "I learned helpful skills" or "Because of what I've learned in the program, I feel that my child is healthier"). The satisfaction items are scored 0 "Strongly Disagree" to 5 "Strongly Agree," and higher total scores correlate with higher levels of satisfaction.
Adherence
Time frame: Study enrollment through study completion, an average of 1 year
We will compare the percent of prescribed visits completed at 6- and 12-months across study arms.
Home visitor-participant relationship
Time frame: 2-months postpartum, 6-months postpartum, 12-months postpartum
We will use the shortened version of the Working Alliance Inventory (WAI). It has 12 items, and the participant and home visitor each complete their own version of the measure. Possible scores for each item on the WAI ranged from 1 "Never" to 7 "Always" and are summed for a total score. A higher score on the WAI indicates a stronger therapeutic alliance.
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 6 Jan 2022.
- Derived from this study: PubMed 36151535Ingalls A, Rebman P, Martin L, Kushman E, Leonard A, Cisler A, Gschwind I, Brayak A, Amsler AM, Haroz EE. Towards precision home visiting: results at six months postpartum from a randomized pilot implementation trial to assess the feasibility of a precision approach to Family Spirit. BMC Pregnancy Childbirth. 2022 Sep 23;22(1):725. doi: 10.1186/s12884-022-05057-4.
- Derived from this study: PubMed 33407939Ingalls A, Barlow A, Kushman E, Leonard A, Martin L, Team PFSS, West AL, Neault N, Haroz EE. Precision Family Spirit: a pilot randomized implementation trial of a precision home visiting approach with families in Michigan-trial rationale and study protocol. Pilot Feasibility Stud. 2021 Jan 6;7(1):8. doi: 10.1186/s40814-020-00753-4.
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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.
Emily Haroz, PhD principal investigator
Johns Hopkins Bloomberg School of Public 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 Precision Family Spirit and Standard Family Spirit in people with Parenting and Mother-Child Relations, run by Johns Hopkins Bloomberg School of Public 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 3 inclusion and 3 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 6 Jan 2022. 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?
Acceptability of the home-visiting program from the perspective of mothers enrolled (time frame: Baseline, 2-months postpartum, 6-months postpartum, 12-months postpartum). The study lists 5 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 NCT03975530, which also lists 2 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 6 Jan 2022.