Extension Study of the Family Spirit Program

Parenting Clinical Trial

Official title:

Extension Study of the Family Spirit Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01910701
• Other study ID #: ADHS12-014900
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: November 30, 2018

Study information

• Verified date: March 2019
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years to 20 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parenting

Intervention

Behavioral:
• Family Spirit
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.

Locations

Country	Name	City	State
United States	Johns Hopkins Center for American Indian Health	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in score on parenting self-efficacy scale		24 months postpartum
Secondary	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
Secondary	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
Secondary	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
Secondary	Improved score on family economic self-sufficiency scale		24 months postpartum
Secondary	Increased referrals for community resources		24 months postpartum