NCT00164697

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
547

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 1999

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

February 3, 2016

Status Verified

September 1, 2012

Enrollment Period

13.3 years

First QC Date

September 13, 2005

Last Update Submit

February 2, 2016

Conditions

Child Development

Keywords

Child DevelopmentParentingChild RearingParent-Child Relations

Outcome Measures

Primary Outcomes (8)

  • child behavior

    1yr, 2 yr, 3 yr, 4 yr, 5 yr

  • child social skills

    1yr, 2 yr, 3 yr, 4 yr, 5 yr

  • child cognition

    1 yr, 3 yr, 5 yr

  • child language/communication

    2 yr, 4 yr, 5 yr

  • child attachment

    2 yr

  • child peer relationships

    5 yr

  • child academics

    4 yr, 5 yr

  • parent-child interaction

    6 months, 5 yr

Secondary Outcomes (9)

  • child physical growth

    baseline, 6 month, 1 yr, 2 yr

  • child violence exposure

    2 yr, 4 yr, 5 yr

  • parenting

    baseline, 6 mos, 2 yr, 3 yr 5 yr

  • maternal health

    baseline, 1 yr 3 yr, 5 yr

  • maternal mental health

    baseline, 1yr, 2yr, 3yr, 4 yr, 5 yr

  • +4 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Parenting group

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.

Interventions

Parenting groupBEHAVIORAL

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.

Also known as: Behavioral
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English speaking
  • Live within 10 miles of UCLA
  • 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

You may not qualify if:

  • Multiple birth greater than twins
  • Existing Substance abuse
  • Existing Mental Health issues

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UCLA Department of Pediatrics

Los Angeles, California, 90095, United States

Location

University of Miami School of Medicine

Miami, Florida, 33101, United States

Location

Related Publications (2)

  • 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.

    PMID: 33941737DERIVED

  • Perou 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.

    PMID: 22917446DERIVED

Study Officials

  • Ruth Perou, PhD

    Centers for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 14, 2005

Study Start

October 1, 1999

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

February 3, 2016

Record last verified: 2012-09

Data Sharing

IPD Sharing
Will not share

Locations

US(2)