PregnancyNCT01456091
Evaluation of the Efficacy of the AIM (Adult Identity Mentoring) 4 Teen Moms Program
A study testing AIM 4 Teen Moms in people with Pregnancy, run by Mathematica Policy Research, Inc. at 4 sites in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of the AIM 4 Teen Moms program in increasing the use of long-term contraceptives, in improving adherence to contraceptives and in preventing rapid repeat pregnancies among parenting adolescents. Read more about this study
- Who is it for?
- Ages 15 to 19 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- AIM 4 Teen Moms
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 954 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2011to Jan 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 15 to 19 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Beneficiaries of California's Adolescent Family Life or Cal-Learn programs in the Los Angeles County area
- Female
- 15 - 19 years old
- Has a child between the ages 1 and 6 months at program start
- English or Spanish speaker
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
El Nido Family Centers-Manchester
Los Angeles, California, 900047
Children's Hospital Los Angeles
Los Angeles, California, 90027
El Nido Family Centers-Mission Hills
Mission Hills, California, 91345
El Nido Family Centers-Pacoima
Pacoima, California, 91331
About this study
The purpose of this study is to evaluate the efficacy of the AIM 4 Teen Moms program in increasing the use of long-term contraceptives, in improving adherence to contraceptives and in preventing rapid repeat pregnancies among parenting adolescents.
Read the detailed description
This study uses a randomized controlled design to evaluate the efficacy of AIM (Adult Identity Mentoring) 4 Teen Moms in reducing the incidence of rapid repeat pregnancies and associated sexual risk behavior. The AIM 4 Teen Moms program is a combination of individual and small group sessions intervention that encourages parenting young women ages 15-19 years old to delay rapid repeat pregnancies for 24 months or later. It consists of seven individual 1-hour long sessions (generally conducted in the participant's home) and two 90-minute group sessions delivered over a 12 week period. Study participants will be adolescent mothers receiving services from California's Adolescent Family Life or Cal-Learn programs in the Los Angeles County area. There will be no intervention delivered to members of the control group. This study is being conducted as part of the national Evaluation of Adolescent Pregnancy Prevention Approaches funded by the U.S. Department of Health and Human Services' Office of Adolescent Health.
- Conditions
- Pregnancy
- Being tested
- AIM 4 Teen Moms
- Keywords
- adolescent pregnancy, adolescent birth, rapid repeat pregnancy, rapid repeat birth, youth development, Pregnancy in Adolescence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIM 4 Teen MomsBehavioural
The AIM (Adult Identity Mentoring) 4 Teen Moms program is a combination of individual and small group sessions intervention that encourages parenting young women ages 15-19 years old to delay rapid repeat pregnancies for 24 months or later.
| Study group | Role | What they receive |
|---|---|---|
| AIM 4 Teen Moms | Experimental | Not described Receives: Behavioral: AIM 4 Teen Moms |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of repeat pregnancy
Measured: 24 months after baseline
Secondary outcomes (2)
Adherence to contraception
Measured: 12 months after baseline
Adherence to contraception
Measured: 24 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionJan 2016
- Study completionJan 2016
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 PregnancyStudies 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
- None (open label)
- Enrolment
- 954 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mathematica Policy Research, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Los Angeles, ETR Associates
- Responsible party
- Sponsor
- Investigators
- Christopher Trenholm, Ph.D., Principal investigator, Mathematica Policy ResearchReginald Covington, Ph.D., Principal investigator, Mathematica Policy ResearchPamela Drake, Ph.D., Principal investigator, ETR Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01456091
- Sponsor's protocol ID
- MPR06549-2
- Status last verified
- Mar 2016
- First submitted
- 18 Oct 2011
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Cederbaum JA, Yoon Y, Lee JO, Desai M, Brown K, Clark L. AIM for Teen Moms: Social Support's Role in Contraception Use Among Young Mothers. J Adolesc Health. 2022 Jul;71(1):78-85. doi: 10.1016/j.jadohealth.2022.01.225. Epub 2022 Mar 15.
PubMed 35300930
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of the AIM (Adult Identity Mentoring) 4 Teen Moms Program
- ClinicalTrials.gov ID
- NCT01456091
- Acronym / sponsor ID
- MPR06549-2
- Conditions
- Pregnancy
- Keywords
- adolescent pregnancy, adolescent birth, rapid repeat pregnancy, rapid repeat birth, youth development, Pregnancy in Adolescence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 954 participants (actual)
- Lead sponsor
- Mathematica Policy Research, Inc.University, hospital or other
- Collaborators
- Children's Hospital Los Angeles, ETR Associates
- Study start
- Oct 2011
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 20 Oct 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.
The purpose of this study is to evaluate the efficacy of the AIM 4 Teen Moms program in increasing the use of long-term contraceptives, in improving adherence to contraceptives and in preventing rapid repeat pregnancies among parenting adolescents.
Detailed description
This study uses a randomized controlled design to evaluate the efficacy of AIM (Adult Identity Mentoring) 4 Teen Moms in reducing the incidence of rapid repeat pregnancies and associated sexual risk behavior. The AIM 4 Teen Moms program is a combination of individual and small group sessions intervention that encourages parenting young women ages 15-19 years old to delay rapid repeat pregnancies for 24 months or later. It consists of seven individual 1-hour long sessions (generally conducted in the participant's home) and two 90-minute group sessions delivered over a 12 week period. Study participants will be adolescent mothers receiving services from California's Adolescent Family Life or Cal-Learn programs in the Los Angeles County area. There will be no intervention delivered to members of the control group. This study is being conducted as part of the national Evaluation of Adolescent Pregnancy Prevention Approaches funded by the U.S. Department of Health and Human Services' Office of Adolescent Health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AIM 4 Teen Moms | Experimental | Behavioral: AIM 4 Teen Moms |
| Control | No intervention | – |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Beneficiaries of California's Adolescent Family Life or Cal-Learn programs in the Los Angeles County area
- Female
- 15 - 19 years old
- Has a child between the ages 1 and 6 months at program start
- English or Spanish speaker
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| AIM 4 Teen MomsThe AIM (Adult Identity Mentoring) 4 Teen Moms program is a combination of individual and small group sessions intervention that encourages parenting young women ages 15-19 years old to delay rapid repeat pregnancies for 24 months or later. | Behavioural | AIM 4 Teen Moms |
Primary outcome
Incidence of repeat pregnancy
Time frame: 24 months after baseline
2 secondary outcomes
Adherence to contraception
Time frame: 12 months after baseline
Adherence to contraception
Time frame: 24 months after baseline
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 22 Mar 2016.
- Derived from this study: PubMed 35300930Cederbaum JA, Yoon Y, Lee JO, Desai M, Brown K, Clark L. AIM for Teen Moms: Social Support's Role in Contraception Use Among Young Mothers. J Adolesc Health. 2022 Jul;71(1):78-85. doi: 10.1016/j.jadohealth.2022.01.225. Epub 2022 Mar 15.
Related trials for Pregnancy
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
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.
Christopher Trenholm, Ph.D. principal investigator
Mathematica Policy Research
Reginald Covington, Ph.D. principal investigator
Mathematica Policy Research
Pamela Drake, Ph.D. principal investigator
ETR Associates
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AIM 4 Teen Moms in people with Pregnancy, run by Mathematica Policy Research, Inc. at 4 sites 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 5 inclusion and 0 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 22 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Incidence of repeat pregnancy (time frame: 24 months after baseline). 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 NCT01456091, 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 22 Mar 2016.