Clinical trial NCT00970853: MOM Program 8-Year Follow-up
Official title: The MOM Program Continuation - 8 Year Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Child Development
Keywords: Evaluate developmental outcomes
Evaluate child cognitive, academic, and behavioral outcomes
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: William Penn Foundation
First posted: 2009-09-03
Enrollment: 187
Sex: ALL
Minimum age (years): 94
Maximum age (years): 98
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Woodcock-Johnson Cognitive Ability Test, 3rd Edition (WJR-III, Cog)
timeFrame: 8 years post original enrollment in study
Secondary outcomes:
measure: Woodcock-Johnson Academic Ability Test, 3rd Edition (WJR-III, Ach), Broad Reading
timeFrame: 8 years from study entry
measure: Woodcock-Johnson Academic Ability Test, 3rd Edition (WJR-III, Ach), Broad Math
timeFrame: 8 years from study entry
measure: Child Behavior Checklist (CBCL), Internalizing
timeFrame: 8 years from study entry
measure: Child Behavior Checklist (CBCL), Externalizing
timeFrame: 8 years from study entry
measure: Child Behavior Checklist (CBCL),Total Problems
timeFrame: 8 years from study entry
measure: Teacher Rating Form (TRF), Internalizing
timeFrame: 8 years from study entry
measure: Teacher Rating Form (TRF), Externalizing
timeFrame: 8 years from study entry
measure: Teacher Rating Form (TRF), Total Problems
timeFrame: 8 years from study entry
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Jerilynn Radcliffe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.