NCT00970853

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
187

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 3, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

March 21, 2014

Completed
Last Updated

April 15, 2014

Status Verified

March 1, 2014

Enrollment Period

2.2 years

First QC Date

September 2, 2009

Results QC Date

December 7, 2011

Last Update Submit

March 20, 2014

Conditions

Child Development

Keywords

Evaluate developmental outcomesEvaluate child cognitive, academic, and behavioral outcomes

Outcome Measures

Primary Outcomes (1)

  • Woodcock-Johnson Cognitive Ability Test, 3rd Edition (WJR-III, Cog)

    The WJR-III, Cog measures intelligence and cognition in children and offers a recent standardization sample and updated item content. The WJR-III, Cog was selected because it includes verbal, nonverbal, and language scales and its recent standardization sample includes an appropriate proportion of children from ethnic minority, limited parent education, and Northeastern U.S. regional families.The mean test score is 100, with a standard deviation of 15. The test yields scores from 55 (worst score) to 145 (best score).

    8 years post original enrollment in study

Secondary Outcomes (8)

  • Woodcock-Johnson Academic Ability Test, 3rd Edition (WJR-III, Ach), Broad Reading

    8 years from study entry

  • Woodcock-Johnson Academic Ability Test, 3rd Edition (WJR-III, Ach), Broad Math

    8 years from study entry

  • Child Behavior Checklist (CBCL), Internalizing

    8 years from study entry

  • Child Behavior Checklist (CBCL), Externalizing

    8 years from study entry

  • Child Behavior Checklist (CBCL),Total Problems

    8 years from study entry

  • +3 more secondary outcomes

Study Arms (2)

Control

ACTIVE COMPARATOR

Control group

Other: Control

MOM Program home visiting

EXPERIMENTAL

Mixed professional support home visiting program.

Behavioral: MOM Program home visiting

Interventions

MOM Program home visitingBEHAVIORAL

Mixed professional home visiting program.

MOM Program home visiting
ControlOTHER

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

Control

Eligibility Criteria

Age94 Months - 98 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • 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.

    PMID: 24187118DERIVED

Results Point of Contact

Title
Dr. Jerilynn Radcliffe
Organization
Children's Hospital of Philadelphia
radcliffe@email.chop.edu
215-590-7446

Study Officials

  • Jerilynn Radcliffe, PhD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

September 2, 2009

First Posted

September 3, 2009

Study Start

March 1, 2009

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

April 15, 2014

Results First Posted

March 21, 2014

Record last verified: 2014-03

Locations

US(1)