Phase 3
Completed N=187
MOM Program 8-Year Follow-up
Source: ClinicalTrials.gov NCT00970853 ↗Enrolled (actual)
187
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcomePrimary: Woodcock-Johnson Cognitive Ability Test, 3rd Edition (WJR-III, Cog) — 89.32; 87.62 units on a scale — p=0.39
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Woodcock-Johnson Cognitive Ability Test, 3rd Edition (WJR-III, Cog) |
89.32; 87.62 | 0.39 |
| SECONDARY Woodcock-Johnson Academic Ability Test, 3rd Edition (WJR-III, Ach), Broad Reading |
90.92; 90.94 | .99 |
| SECONDARY Woodcock-Johnson Academic Ability Test, 3rd Edition (WJR-III, Ach), Broad Math |
94.30; 90.80 | 0.16 |
| SECONDARY Child Behavior Checklist (CBCL), Internalizing |
50.30; 49.16 | .40 |
| SECONDARY Child Behavior Checklist (CBCL), Externalizing |
54.02; 53.12 | .56 |
| SECONDARY Child Behavior Checklist (CBCL),Total Problems |
53.22; 51.81 | .34 |
| SECONDARY Teacher Rating Form (TRF), Internalizing |
48.85; 49.21 | .85 |
| SECONDARY Teacher Rating Form (TRF), Externalizing |
55.75; 54.78 | .61 |
| SECONDARY Teacher Rating Form (TRF), Total Problems |
53.80; 52.94 | .67 |
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
Data sourced from ClinicalTrials.gov (NCT00970853). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.