Stress, PsychologicNCT02856711
Assessing the CenteringPregnancy Planning to Parent Innovation
A study testing Trauma-informed group in people with Stress, Psychologic and Pregnancy, run by Boston Medical Center at 1 site in United States.
Trial summary
The investigators propose to evaluate how the CenteringPregnancy curriculum compared with an enhanced curriculum, with the addition of 2 trauma-informed interventions, affects how new parents prepare for parenting and respond to common stressors. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychologic, Pregnancy
- What is being tested?
- Trauma-informed group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Nov 2016
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fluent in English language. Able to complete a written survey in English.
- Currently participating in CenteringPregnancy groups at Boston Medical Center.
- A woman at least 18 years old or older.
Who cannot join
- Women who do not attend the sessions where the intervention are conducted
- Women <18 years old will not be recruited. All participants will be 18 years old or older.
- Not fluent in English language.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators propose to evaluate how the CenteringPregnancy curriculum compared with an enhanced curriculum, with the addition of 2 trauma-informed interventions, affects how new parents prepare for parenting and respond to common stressors.
Read the detailed description
The two interventions will be 1) A viewing of "All Babies Cry" and a discussion of what it's like to be a new parent and 2) A "Planning to Parent" stress activity where parents discuss when they have felt overwhelmed, the coping mechanisms they used, and what can be done to manage those emotions in the future. The goal of this project is to gain insight from current participants in CenteringPregnancy group care around the ways that these interventions can better prepare parents to deal with the common stresses of parenthood.
The investigators will assess the curriculum by administering pre-test and post-test surveys to CenteringPregancy patients within 6 groups. Three of the groups will use the regular CenteringPregnancy curriculum and 3 of the groups will use the enhanced Centering Pregnancy curriculum. Participants will be recruited to CenteringPregnancy, and thus this study, as part of Boston Medical Center Obstetrics/Gynecology Associate's regular prenatal registration process and will be assigned to prenatal groups based on due date. The informed consent and pre-test will be administered to patients at Session 7 of the CenteringPregnancy curriculum and the post-test will be administered to patients at the postpartum visit. The control CenteringPregnancy groups will follow the regular curriculum as written in the CenteringPregnancy Facilitator's Guide. The experimental CenteringPregnancy groups will follow the regular CenteringPregnancy curriculum, with the addition of the "All Babies Cry" intervention during Session 7 (30-34 weeks) and the "Planning to Parent" stress intervention during Session 8 (32-36 weeks). There will be no individual interviews of participants. Following the postpartum survey, the Research Assistant will conduct electronic medical record chart reviews of the study participants.
The investigators propose to seek between 24 and 36 patients for the 3 control groups and between 24 and 36 patients for the 3 experimental groups, for a total of 48-72 subjects. Pre-test and post-test surveys will be collected by a member of the research team. Surveys will be kept in a locked desk and will later analyzed. The intent of this study is to gather important information on ways to improve group-based prenatal care from a patient-centered, trauma-informed perspective. This will ultimately help to improve both family and child well being and reduce the risk of child abuse, neglect and parental and toxic stress in the greater Boston area.
- Conditions
- Stress, Psychologic, Pregnancy
- Being tested
- Trauma-informed group
- Keywords
- Group Prenatal Visits,CenteringPregnancy
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma-informed groupBehavioural
The two interventions will be: 1) A viewing of "All Babies Cry" and a discussion of what it's like to be a new parent, 2) A "Planning to Parent" stress activity where parents discuss when they have felt overwhelmed, the coping mechanisms they used, and what can be done to manage those emotions in the future. The goal of this project is to gain insight from current participants in CenteringPregnancy group care around the ways that these interventions can better prepare parents to deal with the common stresses of parenthood.
| Study group | Role | What they receive |
|---|---|---|
| Trauma-informed group | Experimental | These groups will use the enhanced Centering Pregnancy curriculum. Receives: Behavioral: Trauma-informed group |
| Control group | No intervention | These groups will use the standard CenteringPregnancy curriculum. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sources of parenting information
Measured: 1 month postpartum
Types of parenting support used
Measured: 1 month postpartum
Types of parental behaviors demonstrated
Measured: 1 month postpartum
Frequency of depressed moods (scale)
Measured: 1 month postpartum
Parents' levels of social support
Measured: 1 month postpartum
Frequency of parenting stress (scale)
Measured: 1 month postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startNov 2015
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Doris Duke Charitable Foundation
- Responsible party
- Principal investigator, Morgan Brockington, Boston Medical Center
- Investigators
- Beth Monahan, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02856711
- Sponsor's protocol ID
- H-34199
- Status last verified
- Nov 2016
- First submitted
- 25 Apr 2016
- Last updated
- 23 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the CenteringPregnancy Planning to Parent Innovation
- ClinicalTrials.gov ID
- NCT02856711
- Acronym / sponsor ID
- H-34199
- Conditions
- Stress, Psychologic, Pregnancy
- Keywords
- Group Prenatal Visits,CenteringPregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Doris Duke Charitable Foundation
- Study start
- Nov 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 5 Aug 2016 (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.
The investigators propose to evaluate how the CenteringPregnancy curriculum compared with an enhanced curriculum, with the addition of 2 trauma-informed interventions, affects how new parents prepare for parenting and respond to common stressors.
Detailed description
The two interventions will be 1) A viewing of "All Babies Cry" and a discussion of what it's like to be a new parent and 2) A "Planning to Parent" stress activity where parents discuss when they have felt overwhelmed, the coping mechanisms they used, and what can be done to manage those emotions in the future. The goal of this project is to gain insight from current participants in CenteringPregnancy group care around the ways that these interventions can better prepare parents to deal with the common stresses of parenthood.
The investigators will assess the curriculum by administering pre-test and post-test surveys to CenteringPregancy patients within 6 groups. Three of the groups will use the regular CenteringPregnancy curriculum and 3 of the groups will use the enhanced Centering Pregnancy curriculum. Participants will be recruited to CenteringPregnancy, and thus this study, as part of Boston Medical Center Obstetrics/Gynecology Associate's regular prenatal registration process and will be assigned to prenatal groups based on due date. The informed consent and pre-test will be administered to patients at Session 7 of the CenteringPregnancy curriculum and the post-test will be administered to patients at the postpartum visit. The control CenteringPregnancy groups will follow the regular curriculum as written in the CenteringPregnancy Facilitator's Guide. The experimental CenteringPregnancy groups will follow the regular CenteringPregnancy curriculum, with the addition of the "All Babies Cry" intervention during Session 7 (30-34 weeks) and the "Planning to Parent" stress intervention during Session 8 (32-36 weeks). There will be no individual interviews of participants. Following the postpartum survey, the Research Assistant will conduct electronic medical record chart reviews of the study participants.
The investigators propose to seek between 24 and 36 patients for the 3 control groups and between 24 and 36 patients for the 3 experimental groups, for a total of 48-72 subjects. Pre-test and post-test surveys will be collected by a member of the research team. Surveys will be kept in a locked desk and will later analyzed. The intent of this study is to gather important information on ways to improve group-based prenatal care from a patient-centered, trauma-informed perspective. This will ultimately help to improve both family and child well being and reduce the risk of child abuse, neglect and parental and toxic stress in the greater Boston area.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trauma-informed group | Experimental | Behavioral: Trauma-informed groupThese groups will use the enhanced Centering Pregnancy curriculum. |
| Control group | No intervention | –These groups will use the standard CenteringPregnancy curriculum. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fluent in English language. Able to complete a written survey in English.
- Currently participating in CenteringPregnancy groups at Boston Medical Center.
- A woman at least 18 years old or older.
Key exclusion criteria (3 listed)
- Women who do not attend the sessions where the intervention are conducted
- Women <18 years old will not be recruited. All participants will be 18 years old or older.
- Not fluent in English language.
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 |
|---|---|---|
| Trauma-informed groupThe two interventions will be: 1) A viewing of "All Babies Cry" and a discussion of what it's like to be a new parent, 2) A "Planning to Parent" stress activity where parents discuss when they have felt overwhelmed, the coping mechanisms they used, and what can be done to manage those emotions in the future. The goal of this project is to gain insight from current participants in CenteringPregnancy group care around the ways that these interventions can better prepare parents to deal with the common stresses of parenthood. | Behavioural | Trauma-informed group |
Primary outcome
Sources of parenting information
Time frame: 1 month postpartum
Types of parenting support used
Time frame: 1 month postpartum
Types of parental behaviors demonstrated
Time frame: 1 month postpartum
Frequency of depressed moods (scale)
Time frame: 1 month postpartum
Parents' levels of social support
Time frame: 1 month postpartum
Frequency of parenting stress (scale)
Time frame: 1 month postpartum
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 23 Nov 2016.
- Individual participant dataSharing planned: Undecided
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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.
Beth Monahan principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma-informed group in people with Stress, Psychologic and Pregnancy, 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 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 23 Nov 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.
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?
Sources of parenting information (time frame: 1 month postpartum). The study lists 6 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 23 Nov 2016.