Manuscript Detail
Screening decision | Screening conclusion |
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Passes screens | Eligible for review |
Rating | Design | Attrition | Baseline equivalence | Reassignment | Confounding factors |
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High | Randomized controlled trial | Low | Established on race/ethnicity, SES, and baseline measures of the outcome. | None | None |
Study participants | American Indian adolescent females ages 12 to 19 years at conception and at 32 weeks or earlier gestation who resided in one of four participating communities were recruited. The study sample included 322 participants who were randomly assigned to either the Family Spirit group (159) or the control group (163). The average age of participants at baseline was 18.1 years. Sixty percent lived with their parents and slightly more than half lived in two or more homes within the past year. Seventy-seven percent of participants were pregnant with their first child. During pregnancy, 14 percent of participants drank alcohol, 19 percent smoked cigarettes, and 13 percent used marijuana. |
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Setting | The program was implemented in four tribal communities across three reservations in Arizona. |
Intervention services | Family Spirit is a home visiting program for young American Indian pregnant and parenting mothers staffed by American Indian paraprofessionals. The program’s goals are to increase mothers’ parenting knowledge and involvement, mothers’ psychosocial functioning, and children’s emotional and behavioral outcomes. The curriculum includes 43 lessons that cover parenting skills, infant development, and maternal psychosocial development. The frequency of the visits depends upon the stage of the program. One-hour home visits are provided weekly during pregnancy, biweekly visits for the first four months following the child’s birth, monthly from 4 to 14 months postpartum, and then bimonthly until the child’s third birthday. The study did not specify the dosage of services that program participants actually received. |
Comparison conditions | Participants in the control group received transportation to and from prenatal and well-baby visits, information on child care and community resources, and referrals for services. |
Staff characteristics and training | Home visitors were trained for more than 80 hours on the evaluation protocol and delivering the intervention. After training, home visitors were required to demonstrate 85 percent mastery or better of the Family Spirit curriculum. Quarterly supervision visits and review of an audio recording of 20 percent of visits were administered to examine whether home visitors adhered to the intervention protocol |
Funding sources | Support for this research was provided by the National Institute on Drug Abuse. |
Author affiliation | Ms. Barlow is part of the team that developed this model. Dr. Walkup was affiliated with the Center for American Indian Health at the Johns Hopkins Bloomberg School of Public Health, where the team that developed this model is based. |
Findings details
Rating | Outcome measure | Effect | Sample | Timing of follow-up | Sample size | Intervention group | Comparison group | Group difference | Effect size | Statistical significance | Notes |
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High | ITSEA - Competence domain | FavorableUnfavorable or ambiguousNo Effect |
Family Spirit RCT, 2006-2008 sample | 12 months | 319 mothers | Adjusted mean = 1.07 | Adjusted mean = 1.02 | Mean difference = 0.05 | Study reported = 0.12 | Not statistically significant, p ≥ 0.05 | |
High | ITSEA - Competence domain, % clinically at risk | FavorableUnfavorable or ambiguousNo Effect |
Family Spirit RCT, 2006-2008 sample | 12 months | 319 mothers | Adjusted % = 20.27 | Adjusted mean % = 17.66 | OR = 0.86 | HomeVEE calculated = 0.10 | Not statistically significant, p ≥ 0.05 | |
High | ITSEA - Dysregulation domain | FavorableUnfavorable or ambiguousNo Effect |
Family Spirit RCT, 2006-2008 sample | 12 months | 319 mothers | Adjusted mean = 0.54 | Adjusted mean = 0.59 | Mean difference = -0.06 | Study reported = -0.15 | Not statistically significant, p ≥ 0.05 | footnote162Negative value is favorable to the intervention. |
High | ITSEA - Dysregulation domain, % clinically at risk | FavorableUnfavorable or ambiguousNo Effect |
Family Spirit RCT, 2006-2008 sample | 12 months | 319 mothers | Adjusted % = 15.80 | Adjusted mean % = 18.67 | OR = 1.37 | HomeVEE calculated = -0.12 | Not statistically significant, p ≥ 0.05 | footnote162Negative value is favorable to the intervention. |
High | ITSEA - Externalizing domain | FavorableUnfavorable or ambiguousNo Effect |
Family Spirit RCT, 2006-2008 sample | 12 months | 319 mothers | Adjusted mean = 0.62 | Adjusted mean = 0.71 | Mean difference = -0.09 | Study reported = -0.19 | Statistically significant, p = 0.03 |
footnote162Negative value is favorable to the intervention. |
High | ITSEA - Externalizing domain, % clinically at risk | FavorableUnfavorable or ambiguousNo Effect |
Family Spirit RCT, 2006-2008 sample | 12 months | 319 mothers | Adjusted % = 13.69 | Adjusted mean % = 20.62 | OR = 1.88 | HomeVEE calculated = -0.30 | Not statistically significant, p ≥ 0.05 | footnote162Negative value is favorable to the intervention. |
High | ITSEA - Internalizing domain | FavorableUnfavorable or ambiguousNo Effect |
Family Spirit RCT, 2006-2008 sample | 12 months | 319 mothers | Adjusted mean = 0.57 | Adjusted mean = 0.62 | Mean difference = -0.05 | Study reported = -0.10 | Not statistically significant, p ≥ 0.05 | footnote162Negative value is favorable to the intervention. |
High | ITSEA - Internalizing domain, % clinically at risk | FavorableUnfavorable or ambiguousNo Effect |
Family Spirit RCT, 2006-2008 sample | 12 months | 319 mothers | Adjusted % = 20.27 | Adjusted mean % = 27.16 | OR = 1.61 | HomeVEE calculated = -0.23 | Not statistically significant, p ≥ 0.05 | footnote162Negative value is favorable to the intervention. |
Rating | Outcome measure | Effect | Sample | Timing of follow-up | Sample size | Intervention group | Comparison group | Group difference | Effect size | Statistical significance | Notes |
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High | ASEBA - Externalizing | FavorableUnfavorable or ambiguousNo Effect |
Family Spirit RCT, 2006-2008 sample | 6 months | 322 mothers | Adjusted mean = 40.09 | Adjusted mean = 41.46 | Mean difference = -1.37 | Study reported = -0.13 | Not statistically significant, p ≥ 0.05 | footnote162Negative value is favorable to the intervention. |
High | ASEBA - Externalizing | FavorableUnfavorable or ambiguousNo Effect |
Family Spirit RCT, 2006-2008 sample | 12 months | 322 mothers | Adjusted mean = 38.20 | Adjusted mean = 40.70 | Mean difference = -2.50 | Study reported = -0.20 | Statistically significant, p = 0.04 |
footnote162Negative value is favorable to the intervention. |
High | ASEBA - Internalizing | FavorableUnfavorable or ambiguousNo Effect |
Family Spirit RCT, 2006-2008 sample | 6 months | 322 mothers | Adjusted mean = 43.80 | Adjusted mean = 45.12 | Mean difference = -1.32 | Study reported = -0.12 | Not statistically significant, p ≥ 0.05 | footnote162Negative value is favorable to the intervention. |
High | ASEBA - Internalizing | FavorableUnfavorable or ambiguousNo Effect |
Family Spirit RCT, 2006-2008 sample | 12 months | 322 mothers | Adjusted mean = 41.48 | Adjusted mean = 43.99 | Mean difference = -2.51 | Study reported = -0.19 | Not statistically significant, p ≥ 0.05 | footnote162Negative value is favorable to the intervention. |
High | ASEBA - Total Problems | FavorableUnfavorable or ambiguousNo Effect |
Family Spirit RCT, 2006-2008 sample | 12 months | 322 mothers | Adjusted mean = 38.01 | Adjusted mean = 40.37 | Mean difference = -2.36 | Study reported = -0.18 | Not statistically significant, p ≥ 0.05 | footnote162Negative value is favorable to the intervention. |
High | ASEBA - Total Problems | FavorableUnfavorable or ambiguousNo Effect |
Family Spirit RCT, 2006-2008 sample | 6 months | 322 mothers | Adjusted mean = 40.27 | Adjusted mean = 41.65 | Mean difference = -1.38 | Study reported = -0.13 | Not statistically significant, p ≥ 0.05 | footnote162Negative value is favorable to the intervention. |
High | CES-D | FavorableUnfavorable or ambiguousNo Effect |
Family Spirit RCT, 2006-2008 sample | 2 months | 322 mothers | Adjusted mean = 13.06 | Adjusted mean = 13.40 | Mean difference = -0.34 | Study reported = -0.07 | Not statistically significant, p ≥ 0.05 | footnote162Negative value is favorable to the intervention. |
High | CES-D | FavorableUnfavorable or ambiguousNo Effect |
Family Spirit RCT, 2006-2008 sample | 6 months | 322 mothers | Adjusted mean = 12.46 | Adjusted mean = 13.41 | Mean difference = -0.95 | Study reported = -0.16 | Not statistically significant, p ≥ 0.05 | footnote162Negative value is favorable to the intervention. |
High | CES-D | FavorableUnfavorable or ambiguousNo Effect |
Family Spirit RCT, 2006-2008 sample | 12 months | 322 mothers | Adjusted mean = 11.54 | Adjusted mean = 13.41 | Mean difference = -1.89 | Study reported = -0.20 | Not statistically significant, p ≥ 0.05 | footnote162Negative value is favorable to the intervention. |
High | POSIT Mental Health | FavorableUnfavorable or ambiguousNo Effect |
Family Spirit RCT, 2006-2008 sample | 2 months | 322 mothers | Adjusted mean = 3.23 | Adjusted mean = 3.56 | Mean difference = -0.33 | Study reported = -0.13 | Not statistically significant, p ≥ 0.05 | footnote162Negative value is favorable to the intervention. |
High | POSIT Mental Health | FavorableUnfavorable or ambiguousNo Effect |
Family Spirit RCT, 2006-2008 sample | 6 months | 322 mothers | Adjusted mean = 3.05 | Adjusted mean = 3.30 | Mean difference = -0.25 | Study reported = -0.09 | Not statistically significant, p ≥ 0.05 | footnote162Negative value is favorable to the intervention. |
High | POSIT Mental Health | FavorableUnfavorable or ambiguousNo Effect |
Family Spirit RCT, 2006-2008 sample | 12 months | 322 mothers | Adjusted mean = 2.77 | Adjusted mean = 2.91 | Mean difference = -0.14 | Study reported = -0.04 | Not statistically significant, p ≥ 0.05 | footnote162Negative value is favorable to the intervention. |
High | POSIT Substance Abuse | FavorableUnfavorable or ambiguousNo Effect |
Family Spirit RCT, 2006-2008 sample | 2 months | 322 mothers | Adjusted mean = 0.56 | Adjusted mean = 0.61 | Mean difference = -0.05 | Study reported = -0.03 | Not statistically significant, p ≥ 0.05 | footnote162Negative value is favorable to the intervention. |
High | POSIT Substance Abuse | FavorableUnfavorable or ambiguousNo Effect |
Family Spirit RCT, 2006-2008 sample | 6 months | 322 mothers | Adjusted mean = 0.39 | Adjusted mean = 0.55 | Mean difference = -0.16 | Study reported = -0.08 | Not statistically significant, p ≥ 0.05 | footnote162Negative value is favorable to the intervention. |
High | POSIT Substance Abuse | FavorableUnfavorable or ambiguousNo Effect |
Family Spirit RCT, 2006-2008 sample | 12 months | 322 mothers | Adjusted mean = 0.13 | Adjusted mean = 0.45 | Mean difference = -0.32 | Study reported = -0.13 | Not statistically significant, p ≥ 0.05 | footnote162Negative value is favorable to the intervention. |
High | Alcohol - past 30 days, use of | FavorableUnfavorable or ambiguousNo Effect |
Family Spirit RCT, 2006-2008 sample | 6 months | 322 mothers | Adjusted % = 16.88 | Adjusted mean % = 20.02 | OR = 0.71 | HomeVEE calculated = -0.13 | Not statistically significant, p ≥ 0.05 | footnote162Negative value is favorable to the intervention. |
High | Alcohol - past 30 days, use of | FavorableUnfavorable or ambiguousNo Effect |
Family Spirit RCT, 2006-2008 sample | 12 months | 322 mothers | Adjusted % = 25.77 | Adjusted mean % = 21.55 | OR = 1.14 | HomeVEE calculated = 0.14 | Not statistically significant, p ≥ 0.05 | footnote162Negative value is favorable to the intervention. |
High | Alcohol - past 30 days, use of | FavorableUnfavorable or ambiguousNo Effect |
Family Spirit RCT, 2006-2008 sample | 2 months | 322 mothers | Adjusted % = 17.92 | Adjusted mean % = 17.81 | OR = 0.80 | HomeVEE calculated = 0.00 | Not statistically significant, p ≥ 0.05 | footnote162Negative value is favorable to the intervention. |
High | Any alcohol or illegal drug - past 30 days, use of | FavorableUnfavorable or ambiguousNo Effect |
Family Spirit RCT, 2006-2008 sample | 6 months | 322 mothers | Adjusted % = 27.74 | Adjusted mean % = 30.78 | OR = 0.76 | HomeVEE calculated = -0.09 | Not statistically significant, p ≥ 0.05 | footnote162Negative value is favorable to the intervention. |
High | Any alcohol or illegal drug - past 30 days, use of | FavorableUnfavorable or ambiguousNo Effect |
Family Spirit RCT, 2006-2008 sample | 12 months | 322 mothers | Adjusted % = 38.93 | Adjusted mean % = 34.64 | OR = 1.07 | HomeVEE calculated = 0.11 | Not statistically significant, p ≥ 0.05 | footnote162Negative value is favorable to the intervention. |
High | Any alcohol or illegal drug - past 30 days, use of | FavorableUnfavorable or ambiguousNo Effect |
Family Spirit RCT, 2006-2008 sample | 2 months | 322 mothers | Adjusted % = 32.91 | Adjusted mean % = 29.11 | OR = 1.04 | HomeVEE calculated = 0.11 | Not statistically significant, p ≥ 0.05 | footnote162Negative value is favorable to the intervention. |
High | Any illegal drug - past 30 days, use of | FavorableUnfavorable or ambiguousNo Effect |
Family Spirit RCT, 2006-2008 sample | 2 months | 322 mothers | Adjusted % = 22.89 | Adjusted mean % = 21.92 | OR = 0.93 | HomeVEE calculated = 0.03 | Not statistically significant, p ≥ 0.05 | footnote162Negative value is favorable to the intervention. |
High | Any illegal drug - past 30 days, use of | FavorableUnfavorable or ambiguousNo Effect |
Family Spirit RCT, 2006-2008 sample | 12 months | 322 mothers | Adjusted % = 21.34 | Adjusted mean % = 21.90 | OR = 0.83 | HomeVEE calculated = -0.02 | Not statistically significant, p ≥ 0.05 | footnote162Negative value is favorable to the intervention. |
High | Marijuana - past 30 days, use of | FavorableUnfavorable or ambiguousNo Effect |
Family Spirit RCT, 2006-2008 sample | 2 months | 322 mothers | Adjusted % = 20.63 | Adjusted mean % = 21.02 | OR = 0.87 | HomeVEE calculated = -0.01 | Not statistically significant, p ≥ 0.05 | footnote162Negative value is favorable to the intervention. |
High | Marijuana - past 30 days, use of | FavorableUnfavorable or ambiguousNo Effect |
Family Spirit RCT, 2006-2008 sample | 6 months | 322 mothers | Adjusted % = 12.39 | Adjusted mean % = 18.83 | OR = 0.57 | HomeVEE calculated = -0.30 | Not statistically significant, p ≥ 0.05 | footnote162Negative value is favorable to the intervention. |
High | Marijuana - past 30 days, use of | FavorableUnfavorable or ambiguousNo Effect |
Family Spirit RCT, 2006-2008 sample | 12 months | 322 mothers | Adjusted % = 18.91 | Adjusted mean % = 19.65 | OR = 0.83 | HomeVEE calculated = -0.03 | Not statistically significant, p ≥ 0.05 | footnote162Negative value is favorable to the intervention. |
Rating | Outcome measure | Effect | Sample | Timing of follow-up | Sample size | Intervention group | Comparison group | Group difference | Effect size | Statistical significance | Notes |
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High | HOME inventory - 12 months | FavorableUnfavorable or ambiguousNo Effect |
Family Spirit RCT, 2006-2008 sample | 12 months | 322 mothers | Adjusted mean = 25.92 | Adjusted mean = 25.41 | Mean difference = 0.51 | Study reported = 0.08 | Not statistically significant, p ≥ 0.05 | |
High | HOME inventory - 6 months | FavorableUnfavorable or ambiguousNo Effect |
Family Spirit RCT, 2006-2008 sample | 6 months | 322 mothers | Adjusted mean = 22.79 | Adjusted mean = 22.75 | Mean difference = 0.04 | Study reported = 0.01 | Not statistically significant, p ≥ 0.05 | |
High | PLOC Parental self-efficacy - 12 months | FavorableUnfavorable or ambiguousNo Effect |
Family Spirit RCT, 2006-2008 sample | 12 months | 322 mothers | Adjusted mean = 23.21 | Adjusted mean = 24.71 | Mean difference = -1.51 | Study reported = -0.23 | Statistically significant, p = 0.01 |
footnote162Negative value is favorable to the intervention. |
High | PLOC Parental self-efficacy - 6 months | FavorableUnfavorable or ambiguousNo Effect |
Family Spirit RCT, 2006-2008 sample | 6 months | 322 mothers | Adjusted mean = 22.98 | Adjusted mean = 23.83 | Mean difference = -0.85 | Study reported = -0.13 | Not statistically significant, p ≥ 0.05 | footnote162Negative value is favorable to the intervention. |
High | Home safety attitudes | FavorableUnfavorable or ambiguousNo Effect |
Family Spirit RCT, 2006-2008 sample | 12 months | 322 mothers | Adjusted mean = 29.54 | Adjusted mean = 28.61 | Mean difference = 0.94 | Study reported = 0.19 | Statistically significant, p = 0.03 |
|
High | Home safety practices | FavorableUnfavorable or ambiguousNo Effect |
Family Spirit RCT, 2006-2008 sample | 12 months | 322 mothers | Adjusted mean = 1.56 | Adjusted mean = 1.30 | Mean difference = 0.26 | Study reported = 0.16 | Not statistically significant, p ≥ 0.05 | |
High | Parenting knowledge | FavorableUnfavorable or ambiguousNo Effect |
Family Spirit RCT, 2006-2008 sample | 12 months | 322 mothers | Adjusted mean = 15.43 | Adjusted mean = 14.08 | Mean difference = 1.35 | Study reported = 0.33 | Statistically significant, p = 0.001 |
Outcome measure summary
Outcome measure | Description of measure | Data collection method | Properties of measure |
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ITSEA - Competence domain |
Subscale from 126 item normed assessment of child behaviors, the Infant Toddler Social Emotional Assessment | Maternal report | α range = 0.63-.81 |
ITSEA - Competence domain, % clinically at risk |
Subscale from 126 item normed assessment of child behaviors, the Infant Toddler Social Emotional Assessment | Maternal report | α range = 0.63-.81 |
ITSEA - Dysregulation domain |
Subscale from 126 item normed assessment of child behaviors, the Infant Toddler Social Emotional Assessment | Maternal report | α range = 0.63-.81 |
ITSEA - Dysregulation domain, % clinically at risk |
Subscale from 126 item normed assessment of child behaviors, the Infant Toddler Social Emotional Assessment | Maternal report | α range = 0.63-.81 |
ITSEA - Externalizing domain |
Subscale from 126 item normed assessment of child behaviors, the Infant Toddler Social Emotional Assessment | Maternal report | α range = 0.63-.81 |
ITSEA - Externalizing domain, % clinically at risk |
Subscale from 126 item normed assessment of child behaviors, the Infant Toddler Social Emotional Assessment | Maternal report | α range = 0.63-.81 |
ITSEA - Internalizing domain |
Subscale from 126 item normed assessment of child behaviors, the Infant Toddler Social Emotional Assessment | Maternal report | α range = 0.63-.81 |
ITSEA - Internalizing domain, % clinically at risk |
Subscale from 126 item normed assessment of child behaviors, the Infant Toddler Social Emotional Assessment | Maternal report | α range = 0.63-.81 |
Outcome measure | Description of measure | Data collection method | Properties of measure |
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ASEBA - Externalizing |
Achenbach System of Empirically Based Assessment is a 112 item assessment of externalizing, internalizing, and total problems that produces results in relation to multicultural norms | Maternal self-report | α range = 0.69-0.79 across scales |
ASEBA - Internalizing |
Achenbach System of Empirically Based Assessment is a 112 item assessment of externalizing, internalizing, and total problems that produces results in relation to multicultural norms | Maternal self-report | α range = 0.69-0.79 across scales |
ASEBA - Total Problems |
Achenbach System of Empirically Based Assessment is a 112 item assessment of externalizing, internalizing, and total problems that produces results in relation to multicultural norms | Maternal self-report | α range = 0.69-0.79 across scales |
POSIT Mental Health |
Problem Oriented Screening Instrument for Teens is a 139 item assessment containing 6 subscales, which include mental health and substance abuse. | Maternal self-report | α range = 0.60-0.83 across scales |
POSIT Substance Abuse |
Problem Oriented Screening Instrument for Teens is a 139 item assessment containing 6 subscales, which include mental health and substance abuse. | Maternal self-report | α range = 0.60-0.83 across scales |
Alcohol - past 30 days, use of |
Substance use, according to the Voices of Indian Teens survey | Maternal self report | Not applicable |
Any alcohol or illegal drug - past 30 days, use of |
Substance use, according to the Voices of Indian Teens survey | Maternal self report | Not applicable |
Any illegal drug - past 30 days, use of |
Substance use, according to the Voices of Indian Teens survey | Maternal self report | Not applicable |
CES-D |
Center for Epidemiological Studies Depression is a 20-item assessment of depressive symptoms | Maternal self-report | α = 0.88 |
Marijuana - past 30 days, use of |
Substance use, according to the Voices of Indian Teens survey | Maternal self report | Not applicable |
Outcome measure | Description of measure | Data collection method | Properties of measure |
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HOME Inventory - 12 months |
45-item assessment of parental behavior, parent-child interaction, and home environment | Researcher observation | α = 0.75 |
HOME Inventory - 6 months |
45-item assessment of parental behavior, parent-child interaction, and home environment | Researcher observation | α = 0.75 |
PLOC Parental self-efficacy - 12 months |
Self-efficacy subscale from Parental Locus of Control assessment |
Maternal self-report | α = 0.67 |
PLOC Parental self-efficacy - 6 months |
Self-efficacy subscale from Parental Locus of Control assessment |
Maternal self-report | α = 0.67 |
Home safety attitudes |
8-item assessment of attitudes towards home safety for children | Maternal self-report | α = 0.57 for attitudinal component |
Home safety practices |
8-item assessment of attitudes towards home safety for children | Maternal self-report | α = 0.57 for attitudinal component |
Parenting knowledge |
30-item assessment created by the investigator team to measure knowledge gains | Maternal self-report | α = 0.65 |