Chronic Toxic StressYMPNCT05082857
(YMP) Young Moms Program
A study testing "traditional" Parents as Teachers (PAT) and "hybrid" PAT model in people with Chronic Toxic Stress and Developmental/ Behavioral Regression in Young Children, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Young Moms Program (YMP) is designed to address systemic barriers to the health and stability of young moms and their children such as the lack of coordination of service delivery or logistical barriers within the health system. Read more about this study
- Who is it for?
- Ages 14 to 21 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Toxic Stress, Developmental/ Behavioral Regression in Young Children
- What is being tested?
- "traditional" Parents as Teachers (PAT) and "hybrid" PAT model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2021to 5 Jan 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 21 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Subject must be an immediately post-partum mother
- Subject will reside with her newborn
- Subject must be referred from either the Birth Center at Wake Forest Baptist Health or from one of the Wake Forest Baptist Health Patient Priorities Care (PPC) partner practices
- Participants must speak English or Spanish
Who cannot join
- Newborn of participating mothers must be >= 35 weeks of gestation and not have an extended neonatal intensive care unit (NICU) stay
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Science
Winston-Salem, North Carolina, 27157
About this study
Official title: Pediatric Parenting Connections Young Moms Program
Young Moms Program (YMP) is designed to address systemic barriers to the health and stability of young moms and their children such as the lack of coordination of service delivery or logistical barriers within the health system. The YMP also streamlines the referral pipeline, connecting moms to evidence-based resources, and ensuring children complete all recommended assessments prior to kindergarten.
Read the detailed description
This application is a community-engaged research collaboration between the non-profit Imprints Cares, the Wake Forest Baptist Medical Center (WFBMC) Birth Center, and Wake Forest School of Medicine (WFSOM). This project addresses the myriad risks associated with young moms ≤ 21 years old. Because YMP is a tiered program model, services meet parents where they are through a "warm hand-off" approach that uses one-on-one consultation and assessment-based interventions.
- Being tested
- "traditional" Parents as Teachers (PAT), "hybrid" PAT model
- Keywords
- young moms, child health, teen births, child maltreatment, food insecurity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"traditional" Parents as Teachers (PAT)Behavioural
A twice-a-month home visits from trained family educators. Home visits will continue for the remainder of the study period as will the other components of the Parents as Teachers model: regular Group Connections for peer interactions and support, age-appropriate health and developmental screenings, and referrals that reflect mother and infant needs to community agencies that include the Child Development Services Agency (which provides screening for Individuals with Disabilities in Education Act (IDEA) Part C services), family services, intensive mental health services, among others.
"hybrid" PAT modelBehavioural
A six-week virtual evidence-based parenting class entitled What You Do Matters, which will be delivered in partnership with the Pediatric Advocacy Program at WFBMC which combines short parent-educator discussions followed by interactive activities and peer to peer networking.
| Study group | Role | What they receive |
|---|---|---|
| "traditional" Parents as Teachers (PAT) | Active comparator | A twice-a-month home visits from trained family educators. Home visits will continue for the remainder of the study period as will the other components of the Parents as Teachers model: regular Group Connections for peer interactions and support, age-appropriate health and developmental screenings, and referrals that reflect mother and infant needs to community agencies that include the Child Development Services Agency (which provides screening for Individuals with Disabilities in Education Act (IDEA) Part C services), family services, intensive mental health services, among others. The study team will collect baseline data during the first home visit and complete monthly questionnaires during each month the mother is enrolled. An outcome assessment and participation in a focus group will be administered the last month of the study. Receives: Behavioral: "traditional" Parents as Teachers (PAT) |
| "hybrid" PAT model | Experimental | A six-week virtual evidence-based parenting class entitled What You Do Matters, which will be delivered in partnership with the Pediatric Advocacy Program at WFBMC which combines short parent-educator discussions followed by interactive activities and peer to peer networking. Young moms will participate in Group Connections for peer interactions and support. After completing the six-week course, teens will begin receiving once a month home visits, ongoing Group Connections, age-appropriate health and developmental screenings, and referrals that reflect mother and infant needs to other community agencies and resources, as listed above. The study team will collect baseline data prior to the beginning of the virtual What You Do Matters program and will complete monthly questionnaires during each month the mother is enrolled. An outcome assessment and participation in a focus group will be administered the last month of the study. Receives: Behavioral: "hybrid" PAT model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protective Factors Survey Score
The Protective Factors Survey (PFS) is a 20-item measure - The PFS is a validated parent survey designed that assesses protective factors in five areas: family functioning/resiliency, social emotional support, concrete support, nurturing and attachment, and knowledge of parenting/child development - Each subscale is rated 1-7; higher is better - range is 35-175
Measured: Week 1
Protective Factors Survey Score
The Protective Factors Survey (PFS) is a 20-item measure - The PFS is a validated parent survey designed that assesses protective factors in five areas: family functioning/resiliency, social emotional support, concrete support, nurturing and attachment, and knowledge of parenting/child development - Each subscale is rated 1-7; higher is better - range is 35-175
Measured: Week 6
Protective Factors Survey Score
The Protective Factors Survey (PFS) is a 20-item measure - The PFS is a validated parent survey designed that assesses protective factors in five areas: family functioning/resiliency, social emotional support, concrete support, nurturing and attachment, and knowledge of parenting/child development - Each subscale is rated 1-7; higher is better - range is 35-175
Measured: Month 6
Number of Children Screen Positive for Delays Using the Ages and Stages Questionnaire (ASQ 3) Score
The Ages and Stages Questionnaire (ASQ 3) is a validated developmental screening designed for use by and with parents. The ASQ 3 screens for developmental milestones in communication, gross motor, fine motor, problem solving, and personal-social skills - Range is 0-60 for all age levels, higher is better
Measured: Month 2
Number of Children Screen Positive for Delays Using the Ages and Stages Questionnaire (ASQ 3)
The Ages and Stages Questionnaire (ASQ 3) is a validated developmental screening designed for use by and with parents. The ASQ 3 screens for developmental milestones in communication, gross motor, fine motor, problem solving, and personal-social skills - Range is 0-60 for all age levels, higher is better
Measured: Month 4
Number of Children Screen Positive for Delays Using the Ages and Stages Questionnaire (ASQ 3)
The Ages and Stages Questionnaire (ASQ 3) is a validated developmental screening designed for use by and with parents. The ASQ 3 screens for developmental milestones in communication, gross motor, fine motor, problem solving, and personal-social skills - Range is 0-60 for all age levels, higher is better
Measured: Month 6
Number of Children Screen Positive for Delays Using the Ages and Stages Questionnaire: Social-Emotional (ASQ:SE 2) Score
The Ages and Stages Questionnaire: Social-Emotional (ASQ:SE 2) is a validated screening of social and emotional behaviors - Range 0-240, Monitor with scores 25-34, score positive and refer with scores >=35
Measured: Month 2
Number of Children Screen Positive for Delays Using the Ages and Stages Questionnaire: Social-Emotional (ASQ:SE 2) Score
The Ages and Stages Questionnaire: Social-Emotional (ASQ:SE 2) is a validated screening of social and emotional behaviors - Range 0-345, Monitor with scores 35-44 , score positive and refer with scores >=45
Measured: Month 6
The Patient Health Questionnaire (PHQ 9) Score
The Patient Health Questionnaire (PHQ 9) is a self-administered questionnaire that is validated for use in assessing the severity of depression.
Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Validity has been assessed against an independent structured mental health professional (MHP) interview. PHQ-9 score ≥10 had a sensitivity of 88% and a specificity of 88% for major depression.
Measured: Baseline
The Patient Health Questionnaire (PHQ 9) Score
The Patient Health Questionnaire (PHQ 9) is a self-administered questionnaire that is validated for use in assessing the severity of depression.
Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Validity has been assessed against an independent structured mental health professional (MHP) interview. PHQ-9 score ≥10 had a sensitivity of 88% and a specificity of 88% for major depression.
Measured: Month 6
The StimQ2-I Infant Cognitive Home Environment Questionnaire Score No Availability of Learning (ALM)
The StimQ2-I is a validated, interview-based assessment of home environments for use with infants ages five to 12 months. The StimQ2-I focuses on cognitive stimulation by the primary caregiver and contains several scales: Reading-Verbal, Parental Involvement in Developmental Advance, and Parental Verbal Responsivity - subscale range Read = 15, Parental Involvement in Developmental Advance (PIDA) = 5, Performance Validity Test (PVT) = 16 -Total STIMQ-I score range for the no ALM portion is 0-36; higher score is better.
Measured: Month 6
Full STIMQ2-I Including Availability of Learning Materials (ALM)
The StimQ2-I is a validated, interview-based assessment of home environments for use with infants ages five to 12 months. The StimQ2-I focuses on cognitive stimulation by the primary caregiver and contains several scales: Availability of Learning Materials, Reading-Verbal, Parental Involvement in Developmental Advance, and Parental Verbal Responsivity - subscale range Read = 15, Parental Involvement in Developmental Advance (PIDA) = 5, Performance Validity Test (PVT) = 16, Availability of Learning Materials (ALM) = 6 Total score range for the STIMQ2-I including ALM is 0-42--a higher score is better.
Measured: Month 6
Secondary outcomes (9)
Percent of Mothers Currently Using Contraception
Percent of participants regularly using effective contraception
Measured: Month 6
Percent of Mothers Breastfeeding
Percent of mothers breastfeeding
Measured: Week 6, Month 3 and Month 6
Number of Completed Well Child Visits
The team will track completion of well-child visits
Measured: Week 1, Months 2, 4, and 6
Number of Completed Immunizations
The team will track completion of immunizations
Measured: Months 2, 4, and 6
Number of Emergency Department (ED) Visits Per Subject
The team will use WFBMC Epic data to track use of preventive rather than emergent health care
Measured: Month 6
Percent of Mothers That Continue Current Educational Pathway
The study team will track whether or not participants continue their education during the study period
Measured: Month 6
Number of Referrals Placed Per Subject
Program services include developmental screenings, which in turn can lead to diagnostic assessments and, when eligible, enrollment in services. The team will track those infants are receiving the recommended screenings in a timely manner. Then, in cases where there are concerns, the team will follow-up with the young mom to determine whether or not the parent completed a formal assessment and, if eligible, enrolled in services.
Measured: Month 6
Percent of Referrals Completed
Program services include developmental screenings, which in turn can lead to diagnostic assessments and, when eligible, enrollment in services. The team will track those infants are receiving the recommended screenings in a timely manner. Then, in cases where there are concerns, the team will follow-up with the young mom to determine whether or not the parent completed a formal assessment and, if eligible, enrolled in services.
Measured: Month 6
Percent of Completed Referrals That Result in Services
Program services include developmental screenings, which in turn can lead to diagnostic assessments and, when eligible, enrollment in services. The team will track those infants are receiving the recommended screenings in a timely manner. Then, in cases where there are concerns, the team will follow-up with the young mom to determine whether or not the parent completed a formal assessment and, if eligible, enrolled in services.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start21 Dec 2021
- Primary completion5 Jan 2023
- Study completion5 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Toxic StressStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study team will employ a blind randomized design to assign individuals to either the "traditional" Parents as Teachers (PAT) or the "hybrid" PAT model.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Anna Miller-Fitzwater, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082857
- Sponsor's protocol ID
- IRB00076601
- Other IDs
- UL1TR001420
- Acronym
- YMP
- Status last verified
- Apr 2024
- First submitted
- 6 Oct 2021
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Parenting Connections Young Moms Program
- ClinicalTrials.gov ID
- NCT05082857
- Acronym / sponsor ID
- YMP / IRB00076601
- Keywords
- young moms, child health, teen births, child maltreatment, food insecurity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 21 Dec 2021 (actual)
- Primary completion
- 5 Jan 2023 (actual)
- Study completion
- 5 Jan 2023 (actual)
- First posted
- 19 Oct 2021 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Young Moms Program (YMP) is designed to address systemic barriers to the health and stability of young moms and their children such as the lack of coordination of service delivery or logistical barriers within the health system. The YMP also streamlines the referral pipeline, connecting moms to evidence-based resources, and ensuring children complete all recommended assessments prior to kindergarten.
Detailed description
This application is a community-engaged research collaboration between the non-profit Imprints Cares, the Wake Forest Baptist Medical Center (WFBMC) Birth Center, and Wake Forest School of Medicine (WFSOM). This project addresses the myriad risks associated with young moms ≤ 21 years old. Because YMP is a tiered program model, services meet parents where they are through a "warm hand-off" approach that uses one-on-one consultation and assessment-based interventions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The study team will employ a blind randomized design to assign individuals to either the "traditional" Parents as Teachers (PAT) or the "hybrid" PAT model.
| Arm | Type | Receives |
|---|---|---|
| "traditional" Parents as Teachers (PAT) | Active comparator | Behavioral: "traditional" Parents as Teachers (PAT)A twice-a-month home visits from trained family educators. Home visits will continue for the remainder of the study period as will the other components of the Parents as Teachers model: regular Group Connections for peer interactions and support, age-appropriate health and developmental screenings, and referrals that reflect mother and infant needs to community agencies that include the Child Development Services Agency (which provides screening for Individuals with Disabilities in Education Act (IDEA) Part C services), family services, intensive mental health services, among others. The study team will collect baseline data during the first home visit and complete monthly questionnaires during each month the mother is enrolled. An outcome assessment and participation in a focus group will be administered the last month of the study. |
| "hybrid" PAT model | Experimental | Behavioral: "hybrid" PAT modelA six-week virtual evidence-based parenting class entitled What You Do Matters, which will be delivered in partnership with the Pediatric Advocacy Program at WFBMC which combines short parent-educator discussions followed by interactive activities and peer to peer networking. Young moms will participate in Group Connections for peer interactions and support. After completing the six-week course, teens will begin receiving once a month home visits, ongoing Group Connections, age-appropriate health and developmental screenings, and referrals that reflect mother and infant needs to other community agencies and resources, as listed above. The study team will collect baseline data prior to the beginning of the virtual What You Do Matters program and will complete monthly questionnaires during each month the mother is enrolled. An outcome assessment and participation in a focus group will be administered the last month of the study. |
Who may qualify
- Ages
- 14 to 21 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Subject must be an immediately post-partum mother
- Subject will reside with her newborn
- Subject must be referred from either the Birth Center at Wake Forest Baptist Health or from one of the Wake Forest Baptist Health Patient Priorities Care (PPC) partner practices
- Participants must speak English or Spanish
Key exclusion criteria (1 listed)
- Newborn of participating mothers must be >= 35 weeks of gestation and not have an extended neonatal intensive care unit (NICU) stay
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 |
|---|---|---|
| "traditional" Parents as Teachers (PAT)A twice-a-month home visits from trained family educators. Home visits will continue for the remainder of the study period as will the other components of the Parents as Teachers model: regular Group Connections for peer interactions and support, age-appropriate health and developmental screenings, and referrals that reflect mother and infant needs to community agencies that include the Child Development Services Agency (which provides screening for Individuals with Disabilities in Education Act (IDEA) Part C services), family services, intensive mental health services, among others. | Behavioural | "traditional" Parents as Teachers (PAT) |
| "hybrid" PAT modelA six-week virtual evidence-based parenting class entitled What You Do Matters, which will be delivered in partnership with the Pediatric Advocacy Program at WFBMC which combines short parent-educator discussions followed by interactive activities and peer to peer networking. | Behavioural | "hybrid" PAT model |
Primary outcome
Protective Factors Survey Score
Time frame: Week 1
The Protective Factors Survey (PFS) is a 20-item measure - The PFS is a validated parent survey designed that assesses protective factors in five areas: family functioning/resiliency, social emotional support, concrete support, nurturing and attachment, and knowledge of parenting/child development - Each subscale is rated 1-7; higher is better - range is 35-175
Protective Factors Survey Score
Time frame: Week 6
The Protective Factors Survey (PFS) is a 20-item measure - The PFS is a validated parent survey designed that assesses protective factors in five areas: family functioning/resiliency, social emotional support, concrete support, nurturing and attachment, and knowledge of parenting/child development - Each subscale is rated 1-7; higher is better - range is 35-175
Protective Factors Survey Score
Time frame: Month 6
The Protective Factors Survey (PFS) is a 20-item measure - The PFS is a validated parent survey designed that assesses protective factors in five areas: family functioning/resiliency, social emotional support, concrete support, nurturing and attachment, and knowledge of parenting/child development - Each subscale is rated 1-7; higher is better - range is 35-175
Number of Children Screen Positive for Delays Using the Ages and Stages Questionnaire (ASQ 3) Score
Time frame: Month 2
The Ages and Stages Questionnaire (ASQ 3) is a validated developmental screening designed for use by and with parents. The ASQ 3 screens for developmental milestones in communication, gross motor, fine motor, problem solving, and personal-social skills - Range is 0-60 for all age levels, higher is better
Number of Children Screen Positive for Delays Using the Ages and Stages Questionnaire (ASQ 3)
Time frame: Month 4
The Ages and Stages Questionnaire (ASQ 3) is a validated developmental screening designed for use by and with parents. The ASQ 3 screens for developmental milestones in communication, gross motor, fine motor, problem solving, and personal-social skills - Range is 0-60 for all age levels, higher is better
Number of Children Screen Positive for Delays Using the Ages and Stages Questionnaire (ASQ 3)
Time frame: Month 6
The Ages and Stages Questionnaire (ASQ 3) is a validated developmental screening designed for use by and with parents. The ASQ 3 screens for developmental milestones in communication, gross motor, fine motor, problem solving, and personal-social skills - Range is 0-60 for all age levels, higher is better
Number of Children Screen Positive for Delays Using the Ages and Stages Questionnaire: Social-Emotional (ASQ:SE 2) Score
Time frame: Month 2
The Ages and Stages Questionnaire: Social-Emotional (ASQ:SE 2) is a validated screening of social and emotional behaviors - Range 0-240, Monitor with scores 25-34, score positive and refer with scores >=35
Number of Children Screen Positive for Delays Using the Ages and Stages Questionnaire: Social-Emotional (ASQ:SE 2) Score
Time frame: Month 6
The Ages and Stages Questionnaire: Social-Emotional (ASQ:SE 2) is a validated screening of social and emotional behaviors - Range 0-345, Monitor with scores 35-44 , score positive and refer with scores >=45
The Patient Health Questionnaire (PHQ 9) Score
Time frame: Baseline
The Patient Health Questionnaire (PHQ 9) is a self-administered questionnaire that is validated for use in assessing the severity of depression. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Validity has been assessed against an independent structured mental health professional (MHP) interview. PHQ-9 score ≥10 had a sensitivity of 88% and a specificity of 88% for major depression.
The Patient Health Questionnaire (PHQ 9) Score
Time frame: Month 6
The Patient Health Questionnaire (PHQ 9) is a self-administered questionnaire that is validated for use in assessing the severity of depression. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Validity has been assessed against an independent structured mental health professional (MHP) interview. PHQ-9 score ≥10 had a sensitivity of 88% and a specificity of 88% for major depression.
The StimQ2-I Infant Cognitive Home Environment Questionnaire Score No Availability of Learning (ALM)
Time frame: Month 6
The StimQ2-I is a validated, interview-based assessment of home environments for use with infants ages five to 12 months. The StimQ2-I focuses on cognitive stimulation by the primary caregiver and contains several scales: Reading-Verbal, Parental Involvement in Developmental Advance, and Parental Verbal Responsivity - subscale range Read = 15, Parental Involvement in Developmental Advance (PIDA) = 5, Performance Validity Test (PVT) = 16 -Total STIMQ-I score range for the no ALM portion is 0-36; higher score is better.
Full STIMQ2-I Including Availability of Learning Materials (ALM)
Time frame: Month 6
The StimQ2-I is a validated, interview-based assessment of home environments for use with infants ages five to 12 months. The StimQ2-I focuses on cognitive stimulation by the primary caregiver and contains several scales: Availability of Learning Materials, Reading-Verbal, Parental Involvement in Developmental Advance, and Parental Verbal Responsivity - subscale range Read = 15, Parental Involvement in Developmental Advance (PIDA) = 5, Performance Validity Test (PVT) = 16, Availability of Learning Materials (ALM) = 6 Total score range for the STIMQ2-I including ALM is 0-42--a higher score is better.
9 secondary outcomes
Percent of Mothers Currently Using Contraception
Time frame: Month 6
Percent of Mothers Breastfeeding
Time frame: Week 6, Month 3 and Month 6
Number of Completed Well Child Visits
Time frame: Week 1, Months 2, 4, and 6
Number of Completed Immunizations
Time frame: Months 2, 4, and 6
Number of Emergency Department (ED) Visits Per Subject
Time frame: Month 6
Percent of Mothers That Continue Current Educational Pathway
Time frame: Month 6
Number of Referrals Placed Per Subject
Time frame: Month 6
Percent of Referrals Completed
Time frame: Month 6
Percent of Completed Referrals That Result in Services
Time frame: Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Anna Miller-Fitzwater, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "traditional" Parents as Teachers (PAT) and "hybrid" PAT model in people with Chronic Toxic Stress and Developmental/ Behavioral Regression in Young Children, run by Wake Forest University Health Sciences 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 4 inclusion and 1 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 19 Sep 2024. 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?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Protective Factors Survey Score (time frame: Week 1). The study lists 12 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 19 Sep 2024.