Child DevelopmentPhase 3MOM ProgramNCT00231179

The MOM Program: 5 Year Follow-up Study of a Home Visiting Program at The Children's Hospital of Philadelphia

A Phase 3 study testing Home visiting professional support model in people with Child Development, run by Children's Hospital of Philadelphia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 4 to 5 yearsHealthy volunteers can take part
Conditions the study is for: Child Development
What is being tested?: Home visiting professional support model
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 302 participants
Where: 1 siteUnited States
Study dates: Feb 2004to Feb 2007
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 4 to 5 years
All sexes
Healthy volunteers accepted
Child

Inclusion Criteria: Previous enrollment in The MOM Program; child age of 5 years (plus or minus 3 months); willingness to come to office for follow-up assessment visit; parental consent and child assent.

Exclusion Criteria: None.

Trial locations and contacts

1 site in 1 country.

United States1 site

The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: The MOM Program Continuation - 5 Year Follow-up

The purpose of the MOM Program Continuation is to promote child development by helping families become more competent in accessing and using available health, developmental and educational resources. The program focuses are childhood immunizations, Early Intervention services, lead screening, Early Head Start and Head Start enrollment. The Intervention consists of frequent phone calls and home visits to encourage mothers to have their babies immunized on schedule and to participate in needed developmental and educational services. The program seeks to fill the gap between children's need for services and mothers' ability to assure their children's participation in those services.

Read the detailed description

The MOM Program Continuation builds on the work of The MOM Program, a 3 year randomized intervention. The premise of the MOM Program was that professional support through home visits and frequent phone contacts would improve children's cognitive and behavioral development, ultimately improving their early educational success. The children were enrolled in the MOM Program at birth. The MOM Program Continuation provides continued intervention for the children and mothers of the original cohort to assure that the children are prepared for kindergarten entry at 5 years of age and to evaluate the children's cognitive and behavioral outcomes at age 5 years. The program will also create a longitudinal database to study the linkages between maternal cognitive ability and child cognitive, educational, and behavioral outcomes through entry into school.

Conditions: Child Development
Being tested: Home visiting professional support model, Control
Keywords: child, preschool, intelligence, environment, home visiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Home visiting professional support modelBehavioural
Home visits and telephone calls keyed to well child visits.
ControlOther
Also called No intervention, informational booklet only
The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information

Study groups in NCT00231179
Study group	Role	What they receive
Home visiting Intervention	Experimental	Home visiting intervention group. Receives: Behavioral: Home visiting professional support model
Control	Placebo comparator	Control condition did not receive any services. Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III)
Cognitive ability was assessed through the Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III). The WPPSI-III has been developed and standardized for children ages 2 years, 6 months through 7 years, 3 months of age. The WPPSI-III yields a Verbal Score, a Performance Score, a General Language Score, and a Full Scale Score. These scores have a mean of 100 and a standard deviation of 15. The range of possible values is 50 (worst value) to 150 (best value).
Measured: 5 years of age (plus or minus 1 month)
Child Behavior Checklist Internalizing Scale at 5 Years of Age, Percentage of Participants
Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems. Respondents are asked to rate 99 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 range of possible values is 0-100. Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal).
Measured: at child age of 5 years (plus or minus 1 month)
Child Behavior Checklist Externalizing Scale, Percentage of Abnormality in Participants
Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems. Respondents are asked to rate 99 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 range of possible values is 0-100. Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal).
Measured: at child age of 5 years (plus or minus 1 month)
Child Behavior Checklist Aggressive Subscale, Percentage of Abnormality in Participants
Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems. Respondents are asked to rate 99 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 range of possible values is 0-100. Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal).
Measured: at child age of 5 years (plus or minus 1 month)
Child Behavior Checklist Attention Subscale, Percentage of Abnormality in Participants
Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems. Respondents are asked to rate 99 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 range of possible values is 0-100. Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal).
Measured: child age 5 years (plus or minus 1 month)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2004Feb 2007

First posted4 Oct 2005 (estimated)
Study startFeb 2004
Primary completionFeb 2007
Study completionFeb 2007

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.
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: 302 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00231179
Sponsor's protocol ID: 2003-10-3495
Acronym: MOM Program
Status last verified: Oct 2015
First submitted: 30 Sep 2005
Last updated: 23 Nov 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The MOM Program Continuation - 5 Year Follow-up
ClinicalTrials.gov ID: NCT00231179
Acronym / sponsor ID: MOM Program / 2003-10-3495
Conditions: Child Development
Keywords: child, preschool, intelligence, environment, home visiting
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 302 participants (actual)
Lead sponsor: Children's Hospital of PhiladelphiaUniversity, hospital or other
Collaborators: William Penn Foundation, Claneil Foundation, Inc., Robert Wood Johnson Foundation
Study start: Feb 2004
Primary completion: Feb 2007 (actual)
Study completion: Feb 2007 (actual)
First posted: 4 Oct 2005 (estimated)
Results: Posted 2 Jul 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Home visiting Intervention	Experimental	Behavioral: Home visiting professional support modelHome visiting intervention group.
Control	Placebo comparator	Other: ControlControl condition did not receive any services.

Who may qualify

Ages: 4 to 5 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

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
Home visiting professional support modelHome visits and telephone calls keyed to well child visits.	Behavioural	Home visiting Intervention
ControlAlso: No intervention, informational booklet onlyThe control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information	Other	Control

Primary outcome

Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III)
Time frame: 5 years of age (plus or minus 1 month)
Cognitive ability was assessed through the Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III). The WPPSI-III has been developed and standardized for children ages 2 years, 6 months through 7 years, 3 months of age. The WPPSI-III yields a Verbal Score, a Performance Score, a General Language Score, and a Full Scale Score. These scores have a mean of 100 and a standard deviation of 15. The range of possible values is 50 (worst value) to 150 (best value).
Child Behavior Checklist Internalizing Scale at 5 Years of Age, Percentage of Participants
Time frame: at child age of 5 years (plus or minus 1 month)
Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems. Respondents are asked to rate 99 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 range of possible values is 0-100. Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal).
Child Behavior Checklist Externalizing Scale, Percentage of Abnormality in Participants
Time frame: at child age of 5 years (plus or minus 1 month)
Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems. Respondents are asked to rate 99 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 range of possible values is 0-100. Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal).
Child Behavior Checklist Aggressive Subscale, Percentage of Abnormality in Participants
Time frame: at child age of 5 years (plus or minus 1 month)
Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems. Respondents are asked to rate 99 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 range of possible values is 0-100. Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal).
Child Behavior Checklist Attention Subscale, Percentage of Abnormality in Participants
Time frame: child age 5 years (plus or minus 1 month)
Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems. Respondents are asked to rate 99 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 range of possible values is 0-100. Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal).

Results and safety

Results posted to the registry on 2 Jul 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Home Visiting Intervention	152	128
Control	150	126

Primary outcome: Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III)

Time frame: 5 years of age (plus or minus 1 month). Mean (Standard Deviation). Unit: Scores on a scale

Measure	Home Visiting Intervention n = 128	Control n = 126
Value	86.5 (12.6)	87.4 (12.2)

Home Visiting Intervention vs Control: Mean Difference (Final Values): 0.81 (95% CI 0.31 to 2.13), p = 0.59, t-test, 2 sided

Population analysed: Number of children evaluated at 60 month visit.

Primary outcome: Child Behavior Checklist Internalizing Scale at 5 Years of Age, Percentage of Participants

Time frame: at child age of 5 years (plus or minus 1 month). Number. Unit: percentage of participants

Measure	Home Visiting Intervention n = 128	Control n = 126
Value	8 (8.9)	11 (11.2)

Home Visiting Intervention vs Control: Hazard Ratio (HR): 10, p = 0.72, Chi-squared

Population analysed: Number of mothers/caregivers evaluated at 60 month visit.

Primary outcome: Child Behavior Checklist Externalizing Scale, Percentage of Abnormality in Participants

Time frame: at child age of 5 years (plus or minus 1 month). Number. Unit: percentage of participants

Measure	Home Visiting Intervention n = 128	Control n = 126
Value	3	12

Home Visiting Intervention vs Control: Hazard Ratio (HR): 10, p <0.01, Chi-squared

Primary outcome: Child Behavior Checklist Aggressive Subscale, Percentage of Abnormality in Participants

Time frame: at child age of 5 years (plus or minus 1 month). Number. Unit: Percentage of participants

Measure	Home Visiting Intervention n = 128	Control n = 126
Value	4	12

Home Visiting Intervention vs Control: Hazard Ratio (HR): 3, p <0.05, Chi-squared

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Home Visiting Intervention	0 of 152 (0%)	0 of 152 (0%)	Not reported
Control	0 of 150 (0%)	0 of 150 (0%)	Not reported

Limitations and caveats (from the sponsor): The initial high rate of refusal to participate in the study may affect the generalizability of our results. Those who refused study participation were older and did not elaborate on their lack of interest.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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 Home visiting professional support model 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?

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 23 Nov 2015. 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. Some participants in this study may receive a placebo. 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 2 Jul 2010). 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?

Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III) (time frame: 5 years of age (plus or minus 1 month)). The study lists 5 primary outcomes in all. 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 NCT00231179.

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 23 Nov 2015.