MOM Program 8-Year Follow-up

NCT ID: NCT00970853

Last Updated: 2014-04-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

187 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Study measures will evaluate cognitive, academic, and behavioral outcomes for the children, school services received, and caregiver stress and depression. The main study outcome measures include cognitive status, school functioning, and behavior. Long-term outcomes will be studied in attempt to verify the 33 and 60 month significant differences found in school participation and behavior between the intervention and control groups.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study examines 8-year follow-up results from The MOM Program, a randomized controlled trial (RCT) of a mixed professional home visiting program to promote positive developmental outcomes among children in poverty. The earlier study found significant differences in both school participation and behavior among the intervention group at ages 33 and 60 months of age. Families from the original MOM Program RCT that provide informed consent will be eligible for the study when the children are 8 years of age.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Child Development

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

Control group

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

Control group will receive same assessment batteries at follow-up but did not receive the home visiting program.

MOM Program home visiting

Mixed professional support home visiting program.

Group Type EXPERIMENTAL

MOM Program home visiting

Intervention Type BEHAVIORAL

Mixed professional home visiting program.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MOM Program home visiting

Mixed professional home visiting program.

Intervention Type BEHAVIORAL

Control

Control group will receive same assessment batteries at follow-up but did not receive the home visiting program.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Families from the original MOM RCT that participated in the 60 month evaluation
* Able to return to Philadelphia area for testing
* Parental/guardian informed consent and child assent

Exclusion Criteria

* Children unable to complete testing due to sensory, physical, or other deficits, as determined by clinical review by study psychologist
* Caregivers unwilling to authorize the release of school information
* Non-English speaking
Minimum Eligible Age

94 Months

Maximum Eligible Age

98 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

William Penn Foundation

OTHER

Sponsor Role collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jerilynn Radcliffe

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jerilynn Radcliffe, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Radcliffe J, Schwarz D, Zhao H; MOM Program. The MOM Program: home visiting in partnership with pediatric care. Pediatrics. 2013 Nov;132 Suppl 2:S153-9. doi: 10.1542/peds.2013-1021O.

Reference Type DERIVED
PMID: 24187118 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

WPF-228-08

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

09-007041

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Parenting Videos In Primary Care
NCT00558987 COMPLETED NA
New Haven MOMS Partnership
NCT01665872 COMPLETED NA
Parenting Mindfully Study II
NCT05370768 ACTIVE_NOT_RECRUITING NA