Adolescent ParentingMHFE2NCT01926223
Massachusetts Healthy Families Evaluation-2
A study testing Home visiting in people with Adolescent Parenting, run by Tufts University at 1 site in United States.
Trial summary
Massachusetts Healthy Families Evaluation is a randomized controlled trial of a statewide home visiting program for first time parents aged 20 years and under. The evaluation uses a mixed-method design to assess participant outcomes in five program goal areas: 1) prevention child abuse and neglect; 2) optimal child… Read more about this study
- Who is it for?
- Ages 16 to 20 years, women only
- Conditions the study is for
- Adolescent Parenting
- What is being tested?
- Home visiting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Dec 2011
- 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 16 to 20 years
- Women only
- Child, Adult
Who may be able to join
- age between 16 and 21 years
- first-time parent
Who cannot join
- cognitive delay
- not fluent in either Spanish or English
Trial locations and contacts
1 site in 1 country.
About this study
Massachusetts Healthy Families Evaluation is a randomized controlled trial of a statewide home visiting program for first time parents aged 20 years and under. The evaluation uses a mixed-method design to assess participant outcomes in five program goal areas: 1) prevention child abuse and neglect; 2) optimal child development; 3) educational achievement and economic self-sufficiency; 4) parental well-being; and 5) prevention of repeat teenaged births.
- Conditions
- Adolescent Parenting
- Being tested
- Home visiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home visitingOther
| Study group | Role | What they receive |
|---|---|---|
| Home visiting Group | Experimental | Not described Receives: Other: Home visiting |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child abuse and neglect
Measured: 24 months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2013 (estimated)
- Study startFeb 2008
- Primary completionDec 2011
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 Adolescent ParentingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ann Easterbrooks, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926223
- Sponsor's protocol ID
- TuftsU
- Acronym
- MHFE2
- Status last verified
- Aug 2013
- First submitted
- 15 Aug 2013
- Last updated
- 20 Aug 2013
- Results posted
- No
Publications
Easterbrooks MA, Bartlett JD, Raskin M, Goldberg J, Contreras MM, Kotake C, Chaudhuri JH, Jacobs FH. Limiting home visiting effects: maternal depression as a moderator of child maltreatment. Pediatrics. 2013 Nov;132 Suppl 2:S126-33. doi: 10.1542/peds.2013-1021K.
PubMed 24187114
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Massachusetts Healthy Families Evaluation-2
- ClinicalTrials.gov ID
- NCT01926223
- Acronym / sponsor ID
- MHFE2 / TuftsU
- Conditions
- Adolescent Parenting
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Dec 2011 (actual)
- First posted
- 20 Aug 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.
Massachusetts Healthy Families Evaluation is a randomized controlled trial of a statewide home visiting program for first time parents aged 20 years and under. The evaluation uses a mixed-method design to assess participant outcomes in five program goal areas: 1) prevention child abuse and neglect; 2) optimal child development; 3) educational achievement and economic self-sufficiency; 4) parental well-being; and 5) prevention of repeat teenaged births.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home visiting Group | Experimental | Other: Home visiting |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 16 to 20 years
- Sex
- Female only
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- age between 16 and 21 years
- first-time parent
Key exclusion criteria (2 listed)
- cognitive delay
- not fluent in either Spanish or English
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 |
|---|---|---|
| Home visiting | Other | Home visiting Group |
Primary outcome
Child abuse and neglect
Time frame: 24 months post-enrollment
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 20 Aug 2013.
- Derived from this study: PubMed 24187114Easterbrooks MA, Bartlett JD, Raskin M, Goldberg J, Contreras MM, Kotake C, Chaudhuri JH, Jacobs FH. Limiting home visiting effects: maternal depression as a moderator of child maltreatment. Pediatrics. 2013 Nov;132 Suppl 2:S126-33. doi: 10.1542/peds.2013-1021K.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home visiting in people with Adolescent Parenting, run by Tufts University 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 2 inclusion and 2 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 20 Aug 2013. 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?
Child abuse and neglect (time frame: 24 months post-enrollment). 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 NCT01926223, 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 20 Aug 2013.