ParentingPhase 2/3dulceNCT01343940
Strengthening Families and Reducing Risk Thru Developmental and Legal Collaboration
A Phase 2/3 study testing Project dulce and Safety intervention in people with Parenting and Child Rearing, run by Boston Medical Center at 1 site in United States.
Trial summary
Project Dulce is designed to test a new approach to delivering family support, in the context of the primary care medical home. The target population to be served is infants between birth and 6 months old and their families who receive primary care at Boston Medical Center. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Parenting, Child Rearing, Child Abuse
- What is being tested?
- Project dulce and Safety intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 402 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Jun 2013
- Phase
- Phase 2/3
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The patient family must include an infant, or infants for families with multiples, born 10 weeks or less prior to recruitment.
- The newborn(s) must be healthy, having been born without known defects or complications that would require early hospitalization.
- The infant must have been discharged from hospital within one week.
- At the time of recruitment, the parent/guardian will have communicated their intent to obtain their newborn infant's primary pediatric care through Boston Medical Center's (BMC's) Primary Pediatric Care Clinic (PPCC).
- The child's parent/guardian must be able to engage in an informed consent process conducted in English or Spanish.
- The child's parent/guardian must be able to complete a questionnaire and/or interview (with or without assistance) in English or Spanish.
Who cannot join
- The participating parent/guardian is under 18 years of age. As SOC at BMC, mothers under the age of 18 are seen in the The Teen and Tot Program (TTP), a specialized program located within BMC's Adolescent Center.
- The parent/guardian is unable to participate in required data collection activities in the study languages, even with assistance.
- The child/family's physician believes that participation in the evaluation would adversely affect the child/family's health or well being or the ongoing delivery of health care services. Decision will be made based on the physician's clinical judgment. All physicians have the opportunity to opt their patients out.
- The family is already receiving services from another family partner program such as Project RISE, Healthy Steps, etc. through the BMC primary care center.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Project Dulce: Developmental Understanding and Legal Collaboration for Everyone
Project Dulce is designed to test a new approach to delivering family support, in the context of the primary care medical home. The target population to be served is infants between birth and 6 months old and their families who receive primary care at Boston Medical Center. A dulce family partner will reach infants and families through their routine health care visits during their first six months of life and provide them with support for unmet legal needs, screen infants for developmental problems, screen families for mental health problems, and improve families' knowledge of child development. The control group will receive training on safe sleep and safe transportation for their newborn.
Read the detailed description
Subjects for project dulce will be recruited from parents who receive their newborn child's primary pediatric care from Boston Medical Center's Pediatric Primary Care Clinic. Subjects will be randomized to receive the study intervention or the control.
Project dulce will provide a family partner to parents of infants up to six months of age. The dulce family partner (DFP) will be trained using the Healthy Steps model, an evidence-based approach to support parent understanding of child development, and by Medical Legal Partnership|Boston to identify legal and social needs that may affect a child's health and development. The dulce family partner will reach infants and families through their routine health care visits during their first six months of life and provide them with support for unmet legal needs, screen infants for developmental problems, screen families for mental health problems, and improve families' knowledge of child development. Families will meet with the DFP at the initial visit, at their subsequent routine healthcare maintenance visits, and during home visits if they wish.
Families in the control group will receive safety education from a trained staff member on safe sleep and safe transportation, at two of their baby's routine well-child visits between 1 and 6 months of age.
Subjects will answer two sets of standard survey questions before and after intervention / control. The infant's electronic medical record will be reviewed up to the first year. This study will test whether the project dulce intervention promotes positive outcomes for children and families, and reduces risks and adverse outcomes. The results of this rigorous program evaluation may be used to support dissemination of project dulce to other primary care sites throughout the country.
PROJECT GOALS 1. Assess whether the highly-structured dulce intervention results in: improved individual and family strengths, reduced risks, and decreased likelihood of child maltreatment. 2. Provide system-level information to assess the costs, resource needs, barriers, and benefits that come from implementing the dulce model within a patient-centered medical home. 3. In addition to the project's research goals, we will collect aggregated Child Protective Service (CPS) community-wide data regarding childhood injury and maltreatment, as is requested by funder.
- Conditions
- Parenting, Child Rearing, Child Abuse, Child Neglect, Child Development
- Being tested
- Project dulce, Safety intervention
- Keywords
- RCT, randomized block repeated measures design, efficacy trial, high risk population
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project dulceBehavioural
Also called dulce, dulce family partner
Participating families are assigned to a legal/developmental specialist who joins health care team during well-child visits and home visits. The specialist (a "Dulce family partner") supports parent around child development issues, addresses unmet basic needs (e.g., housing, utilities, food, etc.), and makes referral to existing agencies and services. Specialist meets with family during all routine well-child visits scheduled in primary care between birth and 6 months (1-mo, 2-mo, 4-mo, 6-mo). Parent may meet with specialist before or after scheduled appointment, and may request a home visit. Specialist will be available by phone for consultation.
Safety interventionBehavioural
Participating family is assigned a safety specialist. Meeting with the safety specialist will occur before or after a routine well-child visit or at a separately agreed upon time. The specialist will discuss infant injury risks associated with transportation and sleep. The specialist will provide safety equipment (car seat and pack-and-play) and instruct the parent in their proper use.
| Study group | Role | What they receive |
|---|---|---|
| Dulce family partner intervention | Experimental | Participating families are assigned to a legal/developmental specialist who joins health care team during well-child visits and home visits. The specialist (a "Dulce family partner") supports parent around child development issues, addresses unmet basic needs (e.g., housing, utilities, food, etc.), and makes referral to existing agencies and services. Receives: Behavioral: Project dulce |
| Safety intervention | Active comparator | Participating family is assigned a safety specialist who will provide the parent with guidance, equipment and instruction to reduce risk of newborn injury during transport (car seat) and while sleeping (Pack-and-Play). Receives: Behavioral: Safety intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in number of child maltreatment protective factors available to caregiver at 6 months, as measured on the Quality Improvement Center on Early Childhood (QIC) "Caregivers Assessment of Protective Factors"
Paper-and-pencil questionnaire completed by child's caregiver
Measured: t1 (Baseline): at recruitment, prior to intervention; and t2: 6 months later
Change from baseline in number and amount of income supports available to and accessed by caregiver at 6 months, as measured on the Quality Improvement Center on Early Childhood (QIC) "Self-Report Family Inventory" + supplementary questions on $ value
Paper-and-pencil questionnaire completed by child's caregiver
Measured: t1 (Baseline): at recruitment, prior to intervention; and t2: 6 months later
Change from baseline in social capital available to caregiver at 6 months, as measured on the Quality Improvement Center on Early Childhood (QIC) "Social Network Grid"
Paper-and-pencil questionnaire completed by child's caregiver working with reasearch interviewer. Adapted from: Tracy, EM \& Whittaker, JK (1990). The Social Network Map: Assessing social support in clinical social work practice. Families in Society, 71(8), 461-470.
Measured: t1 (Baseline): at recruitment, prior to intervention; and t2: 6 months later
Change from baseline in parental stress at 6 months, as measured by the "Parenting Stress Index (PSI) - long form"
Paper-and-pencil instrument completed by child's caregiver
Measured: t1 (Baseline): at recruitment, prior to intervention; and t2: 6 months later
Change from baseline in parenting and child-rearing attitudes of child's caregiver at 6 months, as measured on the "Adult-Adolescent Parenting Inventory(AAPI-2)"
Paper-and-pencil instrument completed by child's caregiver; 40 Likert-type items.
Measured: t1 (Baseline): at recruitment, prior to intervention; and t2: 6 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2012
- Study completionJun 2013
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.
- More trials run by Boston Medical CenterThe 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Center for the Study of Social Policy
- Responsible party
- Principal investigator, Robert Sege, Boston Medical Center
- Investigators
- Robert D Sege, MD, PhD, Principal investigator, Boston UniversityEdward De Vos, EdD, Study director, William James College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01343940
- Sponsor's protocol ID
- H-29958
- Acronym
- dulce
- Status last verified
- Jan 2011
- First submitted
- 16 Mar 2011
- Last updated
- 18 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Sege R, Preer G, Morton SJ, Cabral H, Morakinyo O, Lee V, Abreu C, De Vos E, Kaplan-Sanoff M. Medical-Legal Strategies to Improve Infant Health Care: A Randomized Trial. Pediatrics. 2015 Jul;136(1):97-106. doi: 10.1542/peds.2014-2955. Epub 2015 Jun 1.
PubMed 26034248Sege R., Kaplan-Sanoff M., Morton S., Velasco-Hodgson M.C., Preer G., Morakinyo G., De Vos E., Krathen J. Project DULCE: Strengthening families through enhanced primary care. The Journal of Zero to Three. Vol 35(1):10-18, September 2014.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Dulce: Developmental Understanding and Legal Collaboration for Everyone
- ClinicalTrials.gov ID
- NCT01343940
- Acronym / sponsor ID
- dulce / H-29958
- Conditions
- Parenting, Child Rearing, Child Abuse, Child Neglect, Child Development
- Keywords
- RCT, randomized block repeated measures design, efficacy trial, high risk population
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Center for the Study of Social Policy
- Study start
- Feb 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 28 Apr 2011 (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.
Project Dulce is designed to test a new approach to delivering family support, in the context of the primary care medical home. The target population to be served is infants between birth and 6 months old and their families who receive primary care at Boston Medical Center. A dulce family partner will reach infants and families through their routine health care visits during their first six months of life and provide them with support for unmet legal needs, screen infants for developmental problems, screen families for mental health problems, and improve families' knowledge of child development. The control group will receive training on safe sleep and safe transportation for their newborn.
Detailed description
Subjects for project dulce will be recruited from parents who receive their newborn child's primary pediatric care from Boston Medical Center's Pediatric Primary Care Clinic. Subjects will be randomized to receive the study intervention or the control.
Project dulce will provide a family partner to parents of infants up to six months of age. The dulce family partner (DFP) will be trained using the Healthy Steps model, an evidence-based approach to support parent understanding of child development, and by Medical Legal Partnership|Boston to identify legal and social needs that may affect a child's health and development. The dulce family partner will reach infants and families through their routine health care visits during their first six months of life and provide them with support for unmet legal needs, screen infants for developmental problems, screen families for mental health problems, and improve families' knowledge of child development. Families will meet with the DFP at the initial visit, at their subsequent routine healthcare maintenance visits, and during home visits if they wish.
Families in the control group will receive safety education from a trained staff member on safe sleep and safe transportation, at two of their baby's routine well-child visits between 1 and 6 months of age.
Subjects will answer two sets of standard survey questions before and after intervention / control. The infant's electronic medical record will be reviewed up to the first year. This study will test whether the project dulce intervention promotes positive outcomes for children and families, and reduces risks and adverse outcomes. The results of this rigorous program evaluation may be used to support dissemination of project dulce to other primary care sites throughout the country.
PROJECT GOALS 1. Assess whether the highly-structured dulce intervention results in: improved individual and family strengths, reduced risks, and decreased likelihood of child maltreatment. 2. Provide system-level information to assess the costs, resource needs, barriers, and benefits that come from implementing the dulce model within a patient-centered medical home. 3. In addition to the project's research goals, we will collect aggregated Child Protective Service (CPS) community-wide data regarding childhood injury and maltreatment, as is requested by funder.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dulce family partner intervention | Experimental | Behavioral: Project dulceParticipating families are assigned to a legal/developmental specialist who joins health care team during well-child visits and home visits. The specialist (a "Dulce family partner") supports parent around child development issues, addresses unmet basic needs (e.g., housing, utilities, food, etc.), and makes referral to existing agencies and services. |
| Safety intervention | Active comparator | Behavioral: Safety interventionParticipating family is assigned a safety specialist who will provide the parent with guidance, equipment and instruction to reduce risk of newborn injury during transport (car seat) and while sleeping (Pack-and-Play). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- The patient family must include an infant, or infants for families with multiples, born 10 weeks or less prior to recruitment.
- The newborn(s) must be healthy, having been born without known defects or complications that would require early hospitalization.
- The infant must have been discharged from hospital within one week.
- At the time of recruitment, the parent/guardian will have communicated their intent to obtain their newborn infant's primary pediatric care through Boston Medical Center's (BMC's) Primary Pediatric Care Clinic (PPCC).
- The child's parent/guardian must be able to engage in an informed consent process conducted in English or Spanish.
Key exclusion criteria (4 listed)
- The participating parent/guardian is under 18 years of age. As SOC at BMC, mothers under the age of 18 are seen in the The Teen and Tot Program (TTP), a specialized program located within BMC's Adolescent Center.
- The parent/guardian is unable to participate in required data collection activities in the study languages, even with assistance.
- The child/family's physician believes that participation in the evaluation would adversely affect the child/family's health or well being or the ongoing delivery of health care services. Decision will be made based on the physician's clinical judgment. All physicians have the opportunity to opt their patients out.
- The family is already receiving services from another family partner program such as Project RISE, Healthy Steps, etc. through the BMC primary care center.
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 |
|---|---|---|
| Project dulceAlso: dulce, dulce family partnerParticipating families are assigned to a legal/developmental specialist who joins health care team during well-child visits and home visits. The specialist (a "Dulce family partner") supports parent around child development issues, addresses unmet basic needs (e.g., housing, utilities, food, etc.), and makes referral to existing agencies and services. Specialist meets with family during all routine well-child visits scheduled in primary care between birth and 6 months (1-mo, 2-mo, 4-mo, 6-mo). Parent may meet with specialist before or after scheduled appointment, and may request a home visit. Specialist will be available by phone for consultation. | Behavioural | Dulce family partner intervention |
| Safety interventionParticipating family is assigned a safety specialist. Meeting with the safety specialist will occur before or after a routine well-child visit or at a separately agreed upon time. The specialist will discuss infant injury risks associated with transportation and sleep. The specialist will provide safety equipment (car seat and pack-and-play) and instruct the parent in their proper use. | Behavioural | Safety intervention |
Primary outcome
Change from baseline in number of child maltreatment protective factors available to caregiver at 6 months, as measured on the Quality Improvement Center on Early Childhood (QIC) "Caregivers Assessment of Protective Factors"
Time frame: t1 (Baseline): at recruitment, prior to intervention; and t2: 6 months later
Paper-and-pencil questionnaire completed by child's caregiver
Change from baseline in number and amount of income supports available to and accessed by caregiver at 6 months, as measured on the Quality Improvement Center on Early Childhood (QIC) "Self-Report Family Inventory" + supplementary questions on $ value
Time frame: t1 (Baseline): at recruitment, prior to intervention; and t2: 6 months later
Paper-and-pencil questionnaire completed by child's caregiver
Change from baseline in social capital available to caregiver at 6 months, as measured on the Quality Improvement Center on Early Childhood (QIC) "Social Network Grid"
Time frame: t1 (Baseline): at recruitment, prior to intervention; and t2: 6 months later
Paper-and-pencil questionnaire completed by child's caregiver working with reasearch interviewer. Adapted from: Tracy, EM \& Whittaker, JK (1990). The Social Network Map: Assessing social support in clinical social work practice. Families in Society, 71(8), 461-470.
Change from baseline in parental stress at 6 months, as measured by the "Parenting Stress Index (PSI) - long form"
Time frame: t1 (Baseline): at recruitment, prior to intervention; and t2: 6 months later
Paper-and-pencil instrument completed by child's caregiver
Change from baseline in parenting and child-rearing attitudes of child's caregiver at 6 months, as measured on the "Adult-Adolescent Parenting Inventory(AAPI-2)"
Time frame: t1 (Baseline): at recruitment, prior to intervention; and t2: 6 months later
Paper-and-pencil instrument completed by child's caregiver; 40 Likert-type items.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2016.
- Results publication: PubMed 26034248Sege R, Preer G, Morton SJ, Cabral H, Morakinyo O, Lee V, Abreu C, De Vos E, Kaplan-Sanoff M. Medical-Legal Strategies to Improve Infant Health Care: A Randomized Trial. Pediatrics. 2015 Jul;136(1):97-106. doi: 10.1542/peds.2014-2955. Epub 2015 Jun 1.
- Results publicationSege R., Kaplan-Sanoff M., Morton S., Velasco-Hodgson M.C., Preer G., Morakinyo G., De Vos E., Krathen J. Project DULCE: Strengthening families through enhanced primary care. The Journal of Zero to Three. Vol 35(1):10-18, September 2014.
- Individual participant dataSharing planned: No
Related trials for Parenting
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
Recruiting
Bonding Before Birth: A mHealth Intervention for First-time Expectant Couples
Anxiety, Pregnancy
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
Not yet recruitingObservational study
The Effects of Extreme Prematurity on Parenting
Depression Disorder, Post Traumatic Stress Disorder PTSD
Enrolling by invitationObservational study
Long-term Impacts of Psychosocial Stimulation and Iron Supplementation
Iron Deficiency Anemia, Parenting Intervention
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.
Robert D Sege, MD, PhD principal investigator
Boston University
Edward De Vos, EdD study director
William James College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Project dulce and Safety intervention in people with Parenting and Child Rearing, run by Boston Medical Center 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 18 May 2016. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change from baseline in number of child maltreatment protective factors available to caregiver at 6 months, as measured on the Quality Improvement Center on Early Childhood (QIC) "Caregivers Assessment of Protective Factors" (time frame: t1 (Baseline): at recruitment, prior to intervention; and t2: 6 months later). 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 NCT01343940, 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 18 May 2016.