Child DevelopmentLegacyNCT00164697
Legacy for Children, an Early Intervention Study to Promote Optimal Child Development in Low-income Families
A study testing Parenting group in people with Child Development, run by Centers for Disease Control and Prevention at 2 sites in United States.
Trial summary
The purpose of this study is to determine if an intervention focused on promoting parent-child interaction, parental responsibility, parental commitment of time and energy, and sense of community results in better developmental outcomes for low-income children. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Child Development
- What is being tested?
- Parenting group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 547 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 1999to Feb 2013
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English speaking
- Live within 10 miles of UCLA
- 18 years of age or older
- Receive their prenatal and well-baby care from MediCal
- Live within 50 minutes of the three community intervention sites
- Reside within zip codes corresponding to the lowest performing schools in the broad Miami area
- Give birth to the target child at participating hospitals
Who cannot join
- Multiple birth greater than twins
- Existing Substance abuse
- Existing Mental Health issues
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UCLA Department of Pediatrics
Los Angeles, California, 90095
University of Miami School of Medicine
Miami, Florida, 33101
About this study
Official title: Legacy for Children, The CDC Parenting Research Projects
The purpose of this study is to determine if an intervention focused on promoting parent-child interaction, parental responsibility, parental commitment of time and energy, and sense of community results in better developmental outcomes for low-income children.
Read the detailed description
The early years of life (birth to age 5 years) are crucial in a child's development. Parents play a critical role in their children's development and are responsible for the environment in which they grow up. Past research shows that the personal characteristics of successful children consistently correlate to parental influences and behavior. Thus, the theoretical foundation in the Legacy study is that parents can positively influence their child's development. Also, parents are more likely to maintain positive parenting behaviors if they are part of a community greater than themselves. Legacy intervention activities are designed to enhance sensitive and responsive parenting, parent/child interaction, and promote a sense of community. Other activities include verbal and cognitive stimulation through parent and parent/child group meetings, visits to the home, and participation in community events. Legacy has both a pilot phase and a main study phase. There are 180 intervention and 120 comparison families in the main study phase and 60 of each in the pilot phase at each study site, Miami and Los Angeles. The 720 participating families are those whose children, on average, would be expected to fall below national norms on a range of developmental outcomes. Process, cost, and short- and long-term outcome data are being collected.
Comparison group: In addition to the current standard of care, the comparison families receive regular comprehensive child development and maternal assessments at 6 months, 1 yr, 2 yr, 3 yr, 4 yr, and 5 yr.
- Conditions
- Child Development
- Being tested
- Parenting group
- Keywords
- Child Development, Parenting, Child Rearing, Parent-Child Relations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenting groupBehavioural
Also called Behavioral
Weekly and periodic (10 weeks blocks with 6 week break) parenting group meetings (2.5-3 hr), periodic one-on-one meetings (2 hr), visits to community resources (2-3 hr per event). Legacy intervention activities are designed to enhance sensitive and responsive parenting, parent/child interaction, and promote a sense of community. Other activities include verbal and cognitive stimulation through parent and parent/child group meetings, visits to the home, and participation in community events.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Parenting group Receives: Behavioral: Parenting group |
| 2 | No intervention | Families in this "usual care" comparison group were not prevented from utilizing any service that would otherwise be available to them, even if the service was similar to the services received in the intervention arm of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
child behavior
Measured: 1yr, 2 yr, 3 yr, 4 yr, 5 yr
child social skills
Measured: 1yr, 2 yr, 3 yr, 4 yr, 5 yr
child cognition
Measured: 1 yr, 3 yr, 5 yr
child language/communication
Measured: 2 yr, 4 yr, 5 yr
child attachment
Measured: 2 yr
child peer relationships
Measured: 5 yr
child academics
Measured: 4 yr, 5 yr
parent-child interaction
Measured: 6 months, 5 yr
Secondary outcomes (9)
child physical growth
Measured: baseline, 6 month, 1 yr, 2 yr
child violence exposure
Measured: 2 yr, 4 yr, 5 yr
parenting
Measured: baseline, 6 mos, 2 yr, 3 yr 5 yr
maternal health
Measured: baseline, 1 yr 3 yr, 5 yr
maternal mental health
Measured: baseline, 1yr, 2yr, 3yr, 4 yr, 5 yr
sense of community
Measured: baseline, 1yr, 2yr, 3yr, 4 yr, 5 yr
community involvement
Measured: baseline, 6 mos, 2yr, 3yr, 5 yr
coping
Measured: 6mos, 2yr, 3 yr, 5 yr
HOME environment
Measured: 1 yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startOct 1999
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Child DevelopmentStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 547 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- RTI International, University of California, Los Angeles, University of Miami
- Responsible party
- Sponsor
- Investigators
- Ruth Perou, PhD, Principal investigator, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00164697
- Sponsor's protocol ID
- CDC-NCBDDD-2524
- Other IDs
- 200-94-0828, 200-98-0110, 200-98-0111
- Acronym
- Legacy
- Status last verified
- Sep 2012
- First submitted
- 13 Sep 2005
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Barry CM, Robinson LR, Kaminski JW, Danielson ML, Jones CL, Lang DL. Behavioral and Socioemotional Outcomes of the Legacy for Children Randomized Control Trial to Promote Healthy Development of Children Living in Poverty, 4 to 6 Years Postintervention. J Dev Behav Pediatr. 2022 Jan 1;43(1):e39-e47. doi: 10.1097/DBP.0000000000000962.
PubMed 33941737Perou R, Elliott MN, Visser SN, Claussen AH, Scott KG, Beckwith LH, Howard J, Katz LF, Smith DC. Legacy for ChildrenTM: a pair of randomized controlled trials of a public health model to improve developmental outcomes among children in poverty. BMC Public Health. 2012 Aug 23;12:691. doi: 10.1186/1471-2458-12-691.
PubMed 22917446
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Legacy for Children, The CDC Parenting Research Projects
- ClinicalTrials.gov ID
- NCT00164697
- Acronym / sponsor ID
- Legacy / CDC-NCBDDD-2524
- Conditions
- Child Development
- Keywords
- Child Development, Parenting, Child Rearing, Parent-Child Relations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 547 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- RTI International, University of California, Los Angeles, University of Miami
- Study start
- Oct 1999
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 14 Sep 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.
The purpose of this study is to determine if an intervention focused on promoting parent-child interaction, parental responsibility, parental commitment of time and energy, and sense of community results in better developmental outcomes for low-income children.
Detailed description
The early years of life (birth to age 5 years) are crucial in a child's development. Parents play a critical role in their children's development and are responsible for the environment in which they grow up. Past research shows that the personal characteristics of successful children consistently correlate to parental influences and behavior. Thus, the theoretical foundation in the Legacy study is that parents can positively influence their child's development. Also, parents are more likely to maintain positive parenting behaviors if they are part of a community greater than themselves. Legacy intervention activities are designed to enhance sensitive and responsive parenting, parent/child interaction, and promote a sense of community. Other activities include verbal and cognitive stimulation through parent and parent/child group meetings, visits to the home, and participation in community events. Legacy has both a pilot phase and a main study phase. There are 180 intervention and 120 comparison families in the main study phase and 60 of each in the pilot phase at each study site, Miami and Los Angeles. The 720 participating families are those whose children, on average, would be expected to fall below national norms on a range of developmental outcomes. Process, cost, and short- and long-term outcome data are being collected.
Comparison group: In addition to the current standard of care, the comparison families receive regular comprehensive child development and maternal assessments at 6 months, 1 yr, 2 yr, 3 yr, 4 yr, and 5 yr.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Parenting groupParenting group |
| 2 | No intervention | –Families in this "usual care" comparison group were not prevented from utilizing any service that would otherwise be available to them, even if the service was similar to the services received in the intervention arm of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- English speaking
- Live within 10 miles of UCLA
- 18 years of age or older
- Receive their prenatal and well-baby care from MediCal
- Live within 50 minutes of the three community intervention sites
Key exclusion criteria (3 listed)
- Multiple birth greater than twins
- Existing Substance abuse
- Existing Mental Health issues
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 |
|---|---|---|
| Parenting groupAlso: BehavioralWeekly and periodic (10 weeks blocks with 6 week break) parenting group meetings (2.5-3 hr), periodic one-on-one meetings (2 hr), visits to community resources (2-3 hr per event). Legacy intervention activities are designed to enhance sensitive and responsive parenting, parent/child interaction, and promote a sense of community. Other activities include verbal and cognitive stimulation through parent and parent/child group meetings, visits to the home, and participation in community events. | Behavioural | 1 |
Primary outcome
child behavior
Time frame: 1yr, 2 yr, 3 yr, 4 yr, 5 yr
child social skills
Time frame: 1yr, 2 yr, 3 yr, 4 yr, 5 yr
child cognition
Time frame: 1 yr, 3 yr, 5 yr
child language/communication
Time frame: 2 yr, 4 yr, 5 yr
child attachment
Time frame: 2 yr
child peer relationships
Time frame: 5 yr
child academics
Time frame: 4 yr, 5 yr
parent-child interaction
Time frame: 6 months, 5 yr
9 secondary outcomes
child physical growth
Time frame: baseline, 6 month, 1 yr, 2 yr
child violence exposure
Time frame: 2 yr, 4 yr, 5 yr
parenting
Time frame: baseline, 6 mos, 2 yr, 3 yr 5 yr
maternal health
Time frame: baseline, 1 yr 3 yr, 5 yr
maternal mental health
Time frame: baseline, 1yr, 2yr, 3yr, 4 yr, 5 yr
sense of community
Time frame: baseline, 1yr, 2yr, 3yr, 4 yr, 5 yr
community involvement
Time frame: baseline, 6 mos, 2yr, 3yr, 5 yr
coping
Time frame: 6mos, 2yr, 3 yr, 5 yr
HOME environment
Time frame: 1 yr
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
- Derived from this study: PubMed 33941737Barry CM, Robinson LR, Kaminski JW, Danielson ML, Jones CL, Lang DL. Behavioral and Socioemotional Outcomes of the Legacy for Children Randomized Control Trial to Promote Healthy Development of Children Living in Poverty, 4 to 6 Years Postintervention. J Dev Behav Pediatr. 2022 Jan 1;43(1):e39-e47. doi: 10.1097/DBP.0000000000000962.
- Derived from this study: PubMed 22917446Perou R, Elliott MN, Visser SN, Claussen AH, Scott KG, Beckwith LH, Howard J, Katz LF, Smith DC. Legacy for ChildrenTM: a pair of randomized controlled trials of a public health model to improve developmental outcomes among children in poverty. BMC Public Health. 2012 Aug 23;12:691. doi: 10.1186/1471-2458-12-691.
- Individual participant dataSharing planned: No
Related trials for Child Development
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Not yet recruiting
Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss
Hearing Loss, Bilateral
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
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.
Ruth Perou, PhD principal investigator
Centers for Disease Control and Prevention
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parenting group in people with Child Development, run by Centers for Disease Control and Prevention 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 7 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 3 Feb 2016. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
child behavior (time frame: 1yr, 2 yr, 3 yr, 4 yr, 5 yr). The study lists 8 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 NCT00164697, which also lists 2 linked publications.
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 3 Feb 2016.