Child DevelopmentPhase 3NCT00970853
MOM Program 8-Year Follow-up
A Phase 3 study testing MOM Program home visiting in people with Child Development, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 94 to 98 months
- Conditions the study is for
- Child Development
- What is being tested?
- MOM Program home visiting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to May 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 94 to 98 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: The MOM Program Continuation - 8 Year Follow-up
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.
Read the 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.
- Conditions
- Child Development
- Being tested
- MOM Program home visiting, Control
- Keywords
- Evaluate developmental outcomes, Evaluate child cognitive, academic, and behavioral outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOM Program home visitingBehavioural
Mixed professional home visiting program.
ControlOther
Control group will receive same assessment batteries at follow-up but did not receive the home visiting program.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Control group Receives: Other: Control |
| MOM Program home visiting | Experimental | Mixed professional support home visiting program. Receives: Behavioral: MOM Program home visiting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 8 years post original enrollment in study
Secondary outcomes (8)
Woodcock-Johnson Academic Ability Test, 3rd Edition (WJR-III, Ach), Broad Reading
The WJR-III, Ach, Broad Reading measures reading achievement in children and offers a recent standardization sample and updated item content. The WJR-III, Ach, Broad Reading was selected because it includes indices of reading and a recent standardization sample that 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).
Measured: 8 years from study entry
Woodcock-Johnson Academic Ability Test, 3rd Edition (WJR-III, Ach), Broad Math
The WJR-III, Ach, Broad Math measures math academic achievement in children and offers a recent standardization sample and updated item content. The WJR-III, Ach, Math was selected because 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).
Measured: 8 years from study entry
Child Behavior Checklist (CBCL), Internalizing
The CBCL is part of The Achenbach System of Empirically Based Assessment (ASEBA)that measures a broad range of behavioral, emotional, and social behaviors. The CBCL is administered in interview format and respondents are asked to rate 112 problem items as 0 for "not true of the child," 1 for "somewhat or sometimes true of the child," and 2 for "very true or often true of the child", based on the past two months. The raw scores from the 112 items are then compared with age- and gender-matched controls from the standardization sample, and standard scores are then derived with a mean of 50 and a standard deviation of 10. Worst value is 80; best value is 30.
Measured: 8 years from study entry
Child Behavior Checklist (CBCL), Externalizing
The CBCL is part of The Achenbach System of Empirically Based Assessment (ASEBA)that measures a broad range of behavioral, emotional, and social behaviors. The CBCL is administered in interview format and respondents are asked to rate 112 problem items as 0 for "not true of the child," 1 for "somewhat or sometimes true of the child," and 2 for "very true or often true of the child", based on the past two months. The raw scores from the 112 items are then compared with age- and gender-matched controls from the standardization sample, and standard scores are derived with a mean of 50 and a standard deviation of 10. The worst possible score is 80 and the best possible score is 30.
Measured: 8 years from study entry
Child Behavior Checklist (CBCL),Total Problems
The CBCL is part of The Achenbach System of Empirically Based Assessment (ASEBA)that measures a broad range of behavioral, emotional, and social behaviors. The CBCL is administered in interview format and respondents are asked to rate 112 problem items as 0 for "not true of the child," 1 for "somewhat or sometimes true of the child," and 2 for "very true or often true of the child", based on the past two months. The raw scores from the 112 items are then compared with age- and gender-matched controls from the standardization sample, and standard scores are derived with a mean of 50 and a standard deviation of 10. Worst score is 80; best score is 30.
Measured: 8 years from study entry
Teacher Rating Form (TRF), Internalizing
The TRF is the companion to the CBCL and is completed by the child's teacher. The TRF measures a broad range of behavioral, emotional, and social functioning. The TRF asks teachers to rate problem behaviors and questions about receipt of educational services. Respondents are asked to rate 112 problem items as 0 for "not true of the child," 1 for "somewhat or sometimes true of the child," and 2 for "very true or often true of the child", based on the past two months. The raw scores from the 112 items are then compared with scores from age- and gender-matched controls from the standardization sample, and standard scores are derived with a mean of 50 and a standard deviation of 10. value is 80; best value is 30.
Measured: 8 years from study entry
Teacher Rating Form (TRF), Externalizing
The TRF is the companion to the CBCL and is completed by the child's teacher. The TRF measures a broad range of behavioral, emotional, and social functioning. The TRF asks teachers to rate problem behaviors and questions about receipt of educational services. Respondents are asked to rate 112 problem items as 0 for "not true of the child," 1 for "somewhat or sometimes true of the child," and 2 for "very true or often true of the child", based on the past two months. The raw scores from the 112 items are then compared with age- and gender-matched controls from the standardization sample, and standard scores are derived with a mean of 50 and a standard deviation of 10. Best score is 30; worst score is 80.
Measured: 8 years from study entry
Teacher Rating Form (TRF), Total Problems
The TRF is the companion to the CBCL and is completed by the child's teacher. The TRF measures a broad range of behavioral, emotional, and social functioning. The TRF asks teachers to rate problem behaviors and questions about receipt of educational services. Respondents are asked to rate 112 problem items as 0 for "not true of the child," 1 for "somewhat or sometimes true of the child," and 2 for "very true or often true of the child", based on the past two months. The raw scores from the 112 items are then compared with age- and gender-matched controls from the standardization sample, and standard scores are derived with a mean of 50 and a standard deviation of 10. Best score is 30; worst score is 80.
Measured: 8 years from study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2009 (estimated)
- Study startMar 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- William Penn Foundation
- Responsible party
- Principal investigator, Jerilynn Radcliffe, Children's Hospital of Philadelphia
- Investigators
- Jerilynn Radcliffe, PhD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00970853
- Sponsor's protocol ID
- 09-007041
- Other IDs
- WPF-228-08
- Status last verified
- Mar 2014
- First submitted
- 2 Sep 2009
- Last updated
- 15 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 24187118
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The MOM Program Continuation - 8 Year Follow-up
- ClinicalTrials.gov ID
- NCT00970853
- Acronym / sponsor ID
- 09-007041
- Conditions
- Child Development
- Keywords
- Evaluate developmental outcomes, Evaluate child cognitive, academic, and behavioral outcomes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- William Penn Foundation
- Study start
- Mar 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 3 Sep 2009 (estimated)
- Results
- Posted 21 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: ControlControl group |
| MOM Program home visiting | Experimental | Behavioral: MOM Program home visitingMixed professional support home visiting program. |
Who may qualify
- Ages
- 94 to 98 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| MOM Program home visitingMixed professional home visiting program. | Behavioural | MOM Program home visiting |
| ControlControl group will receive same assessment batteries at follow-up but did not receive the home visiting program. | Other | Control |
Primary outcome
Woodcock-Johnson Cognitive Ability Test, 3rd Edition (WJR-III, Cog)
Time frame: 8 years post original enrollment in study
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 secondary outcomes
Woodcock-Johnson Academic Ability Test, 3rd Edition (WJR-III, Ach), Broad Reading
Time frame: 8 years from study entry
Woodcock-Johnson Academic Ability Test, 3rd Edition (WJR-III, Ach), Broad Math
Time frame: 8 years from study entry
Child Behavior Checklist (CBCL), Internalizing
Time frame: 8 years from study entry
Child Behavior Checklist (CBCL), Externalizing
Time frame: 8 years from study entry
Child Behavior Checklist (CBCL),Total Problems
Time frame: 8 years from study entry
Teacher Rating Form (TRF), Internalizing
Time frame: 8 years from study entry
Teacher Rating Form (TRF), Externalizing
Time frame: 8 years from study entry
Teacher Rating Form (TRF), Total Problems
Time frame: 8 years from study entry
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24187118Radcliffe 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.
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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.
Jerilynn Radcliffe, PhD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MOM Program home visiting in people with Child Development, run by Children's Hospital of Philadelphia at 1 site 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 3 inclusion and 3 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 15 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Woodcock-Johnson Cognitive Ability Test, 3rd Edition (WJR-III, Cog) (time frame: 8 years post original enrollment in study). 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 NCT00970853, 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 15 Apr 2014.