Journal of the American Academy of Child & Adolescent Psychiatry
New ResearchRandomized Controlled Trial of a Paraprofessional-Delivered In-Home Intervention for Young Reservation-Based American Indian Mothers
Section snippets
Study Design
The study was designed through a long formative development phase that engaged local and cross-tribal advisory boards and a pilot study that proved the intervention feasible and relevant to the target populations.19 Expectant young AI mothers were randomized (1:1) to one of two home-visiting interventions: the Family Spirit intervention versus a breast-feeding/nutrition education program. Mothers received home-visiting lessons from 28 weeks' gestation to 6 months postpartum and were evaluated
Participant Flow
Of the 181 women initially contacted, 175 (97%) were eligible and agreed to enroll (Fig. 1).38 Of the 175 enrolled, 167 (95%) were randomized, with 81 participants assigned to the Family Spirit arm and 86 to the control arm. Attrition rates were significantly higher among treatment versus control group mothers at 2 months (33% versus 17%, p < .05) and 6 months (42% versus 21%, p < .01). Rates of attrition were similar for both groups at 12 months (54% versus 48%, p = .39). For the entire sample
Discussion
This study had several potential limitations. First, attrition rates particularly among treatment group mothers were higher than anticipated. High attrition rates were likely related to participant factors such as Family Spirit intervention time burden and transient living status postdelivery. Also, the attrition prevention protocol for this study did not include maintaining contact with participants or reengaging mothers who missed multiple consecutive sessions. Although mothers lost to
Primary Outcomes
Mothers in the treatment group experienced greater knowledge gains than mothers in the control group at 6 and 12 months postpartum with a positive trend at 2 months. These significant between-group differences replicate findings from our earlier study and confirm the capacity of AI paraprofessionals to engage and educate a sample of AI teen mothers. Higher knowledge scores in the treatment group also provide evidence that the treatment and control conditions were appropriately differentiated
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This article was reviewed under and accepted by Ad Hoc Editor Bonnie T. Zima, M.D., M.P.H.
Financial support for this work was provided by the Substance Abuse Mental Health Services Administration (SAMHSAI: Grant No. UD1SP08860, SAMHSA II: Grant No. UD1SP09588), and the Ford Foundation, the Annie E. Casey Foundation, and the C.S. Mott Foundation. The PI for this work, John Walkup, M.D., had full access to the study data and takes responsibility for the data integrity and accuracy of the analyses.
Supplemental digital content for this article can be found online only. See text for specific links.
The authors thank the Navajo and White Mountain Apache mothers, children, and families who participated in this study. The authors also thank the Navajo and White Mountain Apache leaders and community stakeholders who generously contributed time and wisdom to designing the Family Strengthening intervention and research protocol and reviewing the article. The authors also thank the Indian Health Service colleagues for their long-standing collaboration in health prevention research and service and for their review of the research and article.
The opinions expressed are those of the authors and do not necessarily reflect the views of the Indian Health Service.
This article is the subject of an editorial by Dr. Douglas K. Novins in this issue.
Clinical trial registry information—Family Spirit Study URL: http://www.clinicaltrials.gov. Unique identifier: NCT00356551.