Teen ParenthoodBHCNCT01888809
Building Healthy Children
A study testing Comprehensive preventive services and Screening and referral in people with Teen Parenthood, run by University of Rochester at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of providing a combination of evidence-based behavioral health treatments for mothers who gave birth to their first child prior to the age of 21 and who meet eligibility requirements and their children on prevention of child maltreatment and promotion of positive… Read more about this study
- Who is it for?
- Ages 12 to 23 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Teen Parenthood
- What is being tested?
- Comprehensive preventive services and Screening and referral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,852 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to 1 Aug 2019
- 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 12 to 23 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Participants will include patients drawn from Strong Pediatrics, Anthony Jordan Health Center, Rochester General Hospital, or Highland Family Medicine
- residents of Monroe County,
- Temporary Assistance for Needy Families (TANF) eligible,
- are neither currently active nor have had an indicated CPS report,
- have a mother who is or was under 21 at the birth of her first child, and
- has a maximum of two children under the age of three.
Who cannot join
- Children who have indicated Child Protective reports or who are in foster care at the time of recruitment
- Any children or mothers who are not able to complete the research protocol also will be excluded.
- Potential subjects suffering from extreme medical or psychiatric conditions (such as severe brain injury or psychosis) or serious cognitive impairments (such as mental retardation) that would render them incapable of completing research measures validly will be excluded.
- Mothers with thought disorder, severe depression or suicidality requiring hospitalization, severely limited intellectual functioning (IQ less than 70), and current maternal incarceration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Building Health Children: Randomized Controlled Trial (RCT) Evaluation
This study will evaluate the effectiveness of providing a combination of evidence-based behavioral health treatments for mothers who gave birth to their first child prior to the age of 21 and who meet eligibility requirements and their children on prevention of child maltreatment and promotion of positive socioemotional development.
Read the detailed description
Building Healthy Children is a collaboration of social service and health care agencies, each providing evidence-based services to intervention families in a seamless package. Low-income parents who gave birth to their first child when they were under 21 and who were not involved in the child welfare system were targeted as an at-risk group for whom home visitation services would offer optimal preventive and cost-efficiency outcomes. Services include Interpersonal Psychotherapy [IPT] for maternal depression and Child Parent Psychotherapy [CPP] for maternal-child relationship development and trauma treatment, and Parents As Teachers [PAT]. Families are provided a tiered complement of BHC services based upon risk and current need.
Case management and outreach services are key to assure family engagement and full program participation. An assigned community outreach worker provides a consistent, nurturing relationship that helps retain families in the program and readies parents for the evidence-based treatments, movement towards goals, and behavior change. Outreach workers help to stabilize families and ensure compliance with medical appointments and recommended care.
Most importantly, BHC home-based services are integrated with primary care practices: pediatric, family medicine, and federally qualified neighborhood health center. These comprehensive services are compared with a screening and referral only group in a randomized design. Integration with the child's medical home is an all-inclusive approach to improve child health and well-being and to achieve desired program outcomes.
- Conditions
- Teen Parenthood
- Being tested
- Comprehensive preventive services, Screening and referral
- Keywords
- teen parents, early childhood development, home visitation, evidence-based treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive preventive servicesBehavioural
Also called Parents as Teachers Home visitation, Child-Parent Psychotherapy, Interpersonal Psychotherapy, Outreach support
Combined evidence-based services:Parents as Teachers Home visitation, Child-Parent Psychotherapy, and/or Interpersonal Psychotherapy with outreach support
Screening and referralBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive preventive services | Experimental | Combined comprehensive services:Parents as Teachers Home visitation, Child-Parent Psychotherapy, and/or Interpersonal Psychotherapy with outreach support Receives: Behavioral: Comprehensive preventive services |
| Screening and referral | Active comparator | Annual screening and referral for services as needed Receives: Behavioral: Screening and referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of indicated Child Protective Services (CPS) reports, including change over time
Prevention of indicated Child Protective Services (CPS) reports on mothers and their children
Measured: Baseline and child's age of 12, 24, 36, 48, and 60 months
Secondary outcomes (1)
Reduction in family risks over time
Changes in family risks, including maternal depression, domestic violence exposure, health outcomes, and family stability
Measured: Baseline and child's age of 12, 24, 36, 48, and 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2013 (estimated)
- Study startAug 2007
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
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 Teen ParenthoodStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,852 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Monroe County Department of Human Services, United Way of Greater Rochester
- Responsible party
- Principal investigator, Sheree Toth, University of Rochester
- Investigators
- Sheree L Toth, Ph.D., Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01888809
- Sponsor's protocol ID
- BHC-01
- Acronym
- BHC
- Status last verified
- Mar 2020
- First submitted
- 21 Jun 2013
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Paradis HA, Sandler M, Manly JT, Valentine L. Building healthy children: evidence-based home visitation integrated with pediatric medical homes. Pediatrics. 2013 Nov;132 Suppl 2:S174-9. doi: 10.1542/peds.2013-1021R.
PubMed 24187121
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Health Children: Randomized Controlled Trial (RCT) Evaluation
- ClinicalTrials.gov ID
- NCT01888809
- Acronym / sponsor ID
- BHC / BHC-01
- Conditions
- Teen Parenthood
- Keywords
- teen parents, early childhood development, home visitation, evidence-based treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,852 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Monroe County Department of Human Services, United Way of Greater Rochester
- Study start
- Aug 2007 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 28 Jun 2013 (estimated)
- 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 evaluate the effectiveness of providing a combination of evidence-based behavioral health treatments for mothers who gave birth to their first child prior to the age of 21 and who meet eligibility requirements and their children on prevention of child maltreatment and promotion of positive socioemotional development.
Detailed description
Building Healthy Children is a collaboration of social service and health care agencies, each providing evidence-based services to intervention families in a seamless package. Low-income parents who gave birth to their first child when they were under 21 and who were not involved in the child welfare system were targeted as an at-risk group for whom home visitation services would offer optimal preventive and cost-efficiency outcomes. Services include Interpersonal Psychotherapy [IPT] for maternal depression and Child Parent Psychotherapy [CPP] for maternal-child relationship development and trauma treatment, and Parents As Teachers [PAT]. Families are provided a tiered complement of BHC services based upon risk and current need.
Case management and outreach services are key to assure family engagement and full program participation. An assigned community outreach worker provides a consistent, nurturing relationship that helps retain families in the program and readies parents for the evidence-based treatments, movement towards goals, and behavior change. Outreach workers help to stabilize families and ensure compliance with medical appointments and recommended care.
Most importantly, BHC home-based services are integrated with primary care practices: pediatric, family medicine, and federally qualified neighborhood health center. These comprehensive services are compared with a screening and referral only group in a randomized design. Integration with the child's medical home is an all-inclusive approach to improve child health and well-being and to achieve desired program outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comprehensive preventive services | Experimental | Behavioral: Comprehensive preventive servicesCombined comprehensive services:Parents as Teachers Home visitation, Child-Parent Psychotherapy, and/or Interpersonal Psychotherapy with outreach support |
| Screening and referral | Active comparator | Behavioral: Screening and referralAnnual screening and referral for services as needed |
Who may qualify
- Ages
- 12 to 23 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Participants will include patients drawn from Strong Pediatrics, Anthony Jordan Health Center, Rochester General Hospital, or Highland Family Medicine
- residents of Monroe County,
- Temporary Assistance for Needy Families (TANF) eligible,
- are neither currently active nor have had an indicated CPS report,
- have a mother who is or was under 21 at the birth of her first child, and
Key exclusion criteria (4 listed)
- Children who have indicated Child Protective reports or who are in foster care at the time of recruitment
- Any children or mothers who are not able to complete the research protocol also will be excluded.
- Potential subjects suffering from extreme medical or psychiatric conditions (such as severe brain injury or psychosis) or serious cognitive impairments (such as mental retardation) that would render them incapable of completing research measures validly will be excluded.
- Mothers with thought disorder, severe depression or suicidality requiring hospitalization, severely limited intellectual functioning (IQ less than 70), and current maternal incarceration.
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 |
|---|---|---|
| Comprehensive preventive servicesAlso: Parents as Teachers Home visitation, Child-Parent Psychotherapy, Interpersonal Psychotherapy, Outreach supportCombined evidence-based services:Parents as Teachers Home visitation, Child-Parent Psychotherapy, and/or Interpersonal Psychotherapy with outreach support | Behavioural | Comprehensive preventive services |
| Screening and referral | Behavioural | Screening and referral |
Primary outcome
Prevention of indicated Child Protective Services (CPS) reports, including change over time
Time frame: Baseline and child's age of 12, 24, 36, 48, and 60 months
Prevention of indicated Child Protective Services (CPS) reports on mothers and their children
1 secondary outcome
Reduction in family risks over time
Time frame: Baseline and child's age of 12, 24, 36, 48, and 60 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 19 Mar 2020.
- Derived from this study: PubMed 24187121Paradis HA, Sandler M, Manly JT, Valentine L. Building healthy children: evidence-based home visitation integrated with pediatric medical homes. Pediatrics. 2013 Nov;132 Suppl 2:S174-9. doi: 10.1542/peds.2013-1021R.
- Individual participant dataSharing planned: No
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.
Sheree L Toth, Ph.D. principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive preventive services and Screening and referral in people with Teen Parenthood, run by University of Rochester 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 6 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 19 Mar 2020. 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?
Prevention of indicated Child Protective Services (CPS) reports, including change over time (time frame: Baseline and child's age of 12, 24, 36, 48, and 60 months). 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 NCT01888809, 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 19 Mar 2020; AzTrials last refreshed its copy on 30 Oct 2026.