NCT01910701

Brief Summary

The aim of the proposed research is to implement and evaluate a follow-up study of the impact of the Family Spirit family strengthening program among a high-risk sample of Apache mothers and their children. The Family Spirit intervention is a 52-session home-visiting curriculum administered by American Indian paraprofessionals to young mothers from 28 weeks gestation through the child's first 3 years of life. In a series of pilot studies and a recently completed randomized controlled trial, the Family Spirit intervention has been found to positively impact several maternal, parenting and child outcomes up through three years postpartum. In the proposed study, the investigators will implement the Family Spirit intervention to young mothers (12-20 years at conception), with revisions to several assessment measures and to the curriculum such that the substance abuse prevention curriculum modules will be taught earlier than in the original study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 30, 2013

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

March 28, 2019

Status Verified

March 1, 2019

Enrollment Period

5.9 years

First QC Date

July 17, 2013

Last Update Submit

March 27, 2019

Conditions

Parenting

Keywords

Home visiting interventionsAmerican IndianCommunity based participatory research

Outcome Measures

Primary Outcomes (1)

  • Increase in score on parenting self-efficacy scale

    24 months postpartum

Secondary Outcomes (5)

  • Improved prenatal and infant medical care practices

    24 months postpartum

  • Reduction in emergency department visits due to childhood injuries

    24 months postpartum

  • Improved school readiness scores

    24 months postpartum

  • Improved score on family economic self-sufficiency scale

    24 months postpartum

  • Increased referrals for community resources

    24 months postpartum

Study Arms (1)

Family Spirit Intervention

EXPERIMENTAL

The Family Spirit intervention consists of 52 sessions (30-60 minutes in duration) delivered during a 39-month intervention phase and designed to positively impact a number of maternal and child behavioral and health outcomes.

Behavioral: Family Spirit

Interventions

Family SpiritBEHAVIORAL

The Family Spirit intervention consists of 52 sessions (30-60 minutes in duration) delivered during a 39-month intervention phase and designed to positively impact a number of maternal and child behavioral and health outcomes.

Family Spirit Intervention

Eligibility Criteria

Age12 Years - 20 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Pregnant American Indian female less than or equal to 32 weeks gestation.
  • Reside within 60 miles of Whiteriver Indian Health Service unit.
  • Age 12-20 years of age at time of conception

You may not qualify if:

  • Completed previous randomized controlled trial of Family Spirit
  • ≤11 years old or ≥21 years old at time of conception of index pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Center for American Indian Health

Baltimore, Maryland, 21205, United States

Location

Study Officials

  • Allison Barlow, MPH, MA

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2013

First Posted

July 30, 2013

Study Start

January 1, 2013

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

March 28, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)