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Completed

NCT Number: NCT01910701

Extension Study of the Family Spirit Program

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.

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Key information

Conditions

Parenting

Age range

12 year–20 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Center for American Indian Health

Baltimore, Maryland, 21205, United States

About this study

This is a single group pre-post study designed to evaluate the impact of a home visiting intervention in improving parenting self-efficacy and a number of other maternal and child health and behavioral outcomes among a sample of young mothers, including maternal substance use. The Family Spirit intervention consists of 52 sessions (30-60 minutes in duration) delivered during a 39-month intervention phase. All sessions are designed to be taught at the participant's home, but they may also occur at another location chosen by the participant (e.g. study office, vehicle). Outcome data will be collected at Baseline and at 2 months, 6 months, 12 months, 24 months and 36 months postpartum.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Family Spirit

Behavioral

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.

Primary outcomes

  1. Increase in score on parenting self-efficacy scale

    Time frame: 24 months postpartum

Secondary outcomes

  1. Improved prenatal and infant medical care practices

    Time frame: 24 months postpartum

    Includes: prenatal care utilization, prenatal use of alcohol/drugs, preconception care, inter-birth intervals, screening for maternal depressive symptoms, breastfeeding, well-child visit utilization, maternal and child health insurance status

  2. Reduction in emergency department visits due to childhood injuries

    Time frame: 24 months postpartum

    Includes: visits for children to emergency department for all causes and due to injury, home safety

  3. Improved school readiness scores

    Time frame: 24 months postpartum

    Includes: parent support for children's learning and development, parent knowledge of child development, parenting behaviors, parent-child relationship, parent stress, child's communication and literacy, child's cognitive skills, child's approach to learning, child's social behavior, and child's physical health and development

  4. Improved score on family economic self-sufficiency scale

    Time frame: 24 months postpartum

  5. Increased referrals for community resources

    Time frame: 24 months postpartum

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Registry information

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Jul 30, 2013
Registry last updated
Mar 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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