Extension Study of the Family Spirit Program

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Extension Study of the Family Spirit Program

Conditions
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Parenting

Intervention / Treatment
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* Behavioral: Family Spirit


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Family Spirit Intervention<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in score on parenting self-efficacy scale |  | 24 months postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved prenatal and infant medical care practices | 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 | 24 months postpartum | 
| Reduction in emergency department visits due to childhood injuries | Includes: visits for children to emergency department for all causes and due to injury, home safety | 24 months postpartum | 
| Improved school readiness scores | 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 | 24 months postpartum | 
| Improved score on family economic self-sufficiency scale |  | 24 months postpartum | 
| Increased referrals for community resources |  | 24 months postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Home visiting interventions, American Indian, Community based participatory research