Extension Study of the Family Spirit Program
27. marts 2019 opdateret af: Johns Hopkins Bloomberg School of Public Health
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.
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
92
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Maryland
-
Baltimore, Maryland, Forenede Stater, 21205
- Johns Hopkins Center for American Indian Health
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
12 år til 20 år (Barn, Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Family Spirit Intervention
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.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Increase in score on parenting self-efficacy scale
Tidsramme: 24 months postpartum
|
24 months postpartum
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Improved prenatal and infant medical care practices
Tidsramme: 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
|
24 months postpartum
|
|
Reduction in emergency department visits due to childhood injuries
Tidsramme: 24 months postpartum
|
Includes: visits for children to emergency department for all causes and due to injury, home safety
|
24 months postpartum
|
|
Improved school readiness scores
Tidsramme: 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
|
24 months postpartum
|
|
Improved score on family economic self-sufficiency scale
Tidsramme: 24 months postpartum
|
24 months postpartum
|
|
|
Increased referrals for community resources
Tidsramme: 24 months postpartum
|
24 months postpartum
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Allison Barlow, MPH, MA, Johns Hopkins Bloomberg School of Public Health
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2013
Primær færdiggørelse (Faktiske)
30. november 2018
Studieafslutning (Faktiske)
30. november 2018
Datoer for studieregistrering
Først indsendt
17. juli 2013
Først indsendt, der opfyldte QC-kriterier
25. juli 2013
Først opslået (Skøn)
30. juli 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. marts 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. marts 2019
Sidst verificeret
1. marts 2019
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- ADHS12-014900
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .