Developmental DisabilitiesPhase 1NCT00110292
Preventing Learning Problems in Young Children: A Public Health and Physician-Based Outreach
A Phase 1 study testing Age-specific parenting newsletters and developmental toys, Parent-completed Ages & Stages Questionnaires and Clinic-based distribution of children's books in people with Developmental Disabilities and Language Development Disorders, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 2 sites in United States.
Trial summary
This study will evaluate a program to prevent learning problems in children. The program is an inexpensive public health outreach program designed for families living in poverty and is administered through pediatricians' offices and clinics. Read more about this study
- Who is it for?
- Ages 4 to 7 monthsHealthy volunteers can take part
- Conditions the study is for
- Developmental Disabilities, Language Development Disorders
- What is being tested?
- Age-specific parenting newsletters and developmental toys, Parent-completed Ages & Stages Questionnaires and Clinic-based distribution of children's books
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 600 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2002to Feb 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 7 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Attend participating pediatric clinic (serving poor, largely black, and Hispanic communities)
- Family with child 4 to 7 months of age at enrollment
- English- or Spanish-speaking
Who cannot join
- Developmental delay
- Eligible for Early Intervention program
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Montefiore Comprehensive Health Care Center
The Bronx, New York, 10451
North Central Bronx Hospital Pediatric Clinic
The Bronx, New York, 10467
About this study
Official title: An RCT of a Low-Intensity Intervention to Reduce Delay
This study will evaluate a program to prevent learning problems in children. The program is an inexpensive public health outreach program designed for families living in poverty and is administered through pediatricians' offices and clinics.
Read the detailed description
This study will assess the effectiveness of a low-intensity, low-cost, preventive intervention to reduce developmental delay and learning problems in young children. The goal is to improve home caregiving environment factors that are often suboptimal in families living in poverty; these families are often subject to social, economic, and medical risk factors. The intervention is based on a public health/primary care partnership and combines mailed parent-completed Ages \& Stages Questionnaires (ASQ), a monthly mailed age-paced parenting newsletter (Building Blocks) and corresponding developmental toys (BB), and a Reach Out and Read (ROR) physician-based distribution of children's books.
Families of 4- to 7-month-old children attending a participating pediatric clinic will be randomized to either an ASQ/BB+ROR group, an ROR-only group, or a no intervention control group. Outcomes measures will be obtained at 15, 24, 36, and 48 months of age and include measures of the home environment, parenting and parent-child interaction, child language and mental development measures, and rates of referral to Early Intervention programs. Baseline and ongoing demographic information and psychosocial and biological risk factors will also be gathered to see how they relate to child and family outcomes and to determine whether certain subgroups of families are more likely to benefit from the intervention than others.
- Being tested
- Age-specific parenting newsletters and developmental toys, Parent-completed Ages & Stages Questionnaires, Clinic-based distribution of children's books
- Keywords
- Public health, Primary care, Parenting education, Child rearing, Parenting newsletters, Child development, Language delay
- Medical subject headings
- Developmental Disabilities, Language Development Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Age-specific parenting newsletters and developmental toysBehavioural
Parent-completed Ages & Stages QuestionnairesBehavioural
Clinic-based distribution of children's booksBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2005 (estimated)
- Study startMar 2002
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental DisabilitiesStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Harris S. Huberman, MD, Principal investigator, Medical & Health Research Association of NYC, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00110292
- Sponsor's protocol ID
- R01HD040388
- Status last verified
- May 2005
- First submitted
- 5 May 2005
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An RCT of a Low-Intensity Intervention to Reduce Delay
- ClinicalTrials.gov ID
- NCT00110292
- Acronym / sponsor ID
- R01HD040388
- Keywords
- Public health, Primary care, Parenting education, Child rearing, Parenting newsletters, Child development, Language delay
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Mar 2002
- Study completion
- Feb 2006
- First posted
- 6 May 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate a program to prevent learning problems in children. The program is an inexpensive public health outreach program designed for families living in poverty and is administered through pediatricians' offices and clinics.
Detailed description
This study will assess the effectiveness of a low-intensity, low-cost, preventive intervention to reduce developmental delay and learning problems in young children. The goal is to improve home caregiving environment factors that are often suboptimal in families living in poverty; these families are often subject to social, economic, and medical risk factors. The intervention is based on a public health/primary care partnership and combines mailed parent-completed Ages \& Stages Questionnaires (ASQ), a monthly mailed age-paced parenting newsletter (Building Blocks) and corresponding developmental toys (BB), and a Reach Out and Read (ROR) physician-based distribution of children's books.
Families of 4- to 7-month-old children attending a participating pediatric clinic will be randomized to either an ASQ/BB+ROR group, an ROR-only group, or a no intervention control group. Outcomes measures will be obtained at 15, 24, 36, and 48 months of age and include measures of the home environment, parenting and parent-child interaction, child language and mental development measures, and rates of referral to Early Intervention programs. Baseline and ongoing demographic information and psychosocial and biological risk factors will also be gathered to see how they relate to child and family outcomes and to determine whether certain subgroups of families are more likely to benefit from the intervention than others.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
Who may qualify
- Ages
- 4 to 7 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Attend participating pediatric clinic (serving poor, largely black, and Hispanic communities)
- Family with child 4 to 7 months of age at enrollment
- English- or Spanish-speaking
Key exclusion criteria (2 listed)
- Developmental delay
- Eligible for Early Intervention program
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 |
|---|---|---|
| Age-specific parenting newsletters and developmental toys | Behavioural | – |
| Parent-completed Ages & Stages Questionnaires | Behavioural | – |
| Clinic-based distribution of children's books | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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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.
Harris S. Huberman, MD principal investigator
Medical & Health Research Association of NYC, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Age-specific parenting newsletters and developmental toys, Parent-completed Ages & Stages Questionnaires and Clinic-based distribution of children's books in people with Developmental Disabilities and Language Development Disorders, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 2 sites 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 2 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: status not confirmed, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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.
Where can I read the original study information?
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 24 Jun 2005.