Manuscript Detail | Home Visiting Evidence of Effectiveness

Barlow, A., Mullany, B., Neault, N., Compton, S., Carter, A., Hastings, R., Billy, T., CohoMescal, V., Lorenzo, S., & Walkup, J. T. (Jan 2013). Effect of a paraprofessional home-visiting intervention on American Indian teen mothers’ and infants’ behavioral risks: A randomized controlled trial. The American Journal of Psychiatry, 170(1), 83-93.

Manuscript screening details
Screening decision	Screening conclusion
Passes screens	Eligible for review

Study design details
Rating	Design	Attrition	Baseline equivalence	Reassignment	Confounding factors
High	Randomized controlled trial	Low	Established on race/ethnicity, SES, and baseline measures of the outcome.	None	None

Study characteristics
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.
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.

Study Registration:

Clinicaltrials.gov Identifier: NCT00373750

Findings details

Child development and school readiness
Rating	Outcome measure	Effect	Sample	Timing of follow-up	Sample size	Intervention group	Comparison group	Group difference	Effect size	Statistical significance	Notes
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 &#37 = 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	footnote162 Submitted by user on Fri, 03/15/2019 - 14:29 Negative 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 &#37 = 15.80	Adjusted mean % = 18.67	OR = 1.37	HomeVEE calculated = -0.12	Not statistically significant, p ≥ 0.05	footnote162 Submitted by user on Fri, 03/15/2019 - 14:29 Negative 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	footnote162 Submitted by user on Fri, 03/15/2019 - 14:29 Negative 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 &#37 = 13.69	Adjusted mean % = 20.62	OR = 1.88	HomeVEE calculated = -0.30	Not statistically significant, p ≥ 0.05	footnote162 Submitted by user on Fri, 03/15/2019 - 14:29 Negative 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	footnote162 Submitted by user on Fri, 03/15/2019 - 14:29 Negative 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 &#37 = 20.27	Adjusted mean % = 27.16	OR = 1.61	HomeVEE calculated = -0.23	Not statistically significant, p ≥ 0.05	footnote162 Submitted by user on Fri, 03/15/2019 - 14:29 Negative value is favorable to the intervention.

Maternal health
Rating	Outcome measure	Effect	Sample	Timing of follow-up	Sample size	Intervention group	Comparison group	Group difference	Effect size	Statistical significance	Notes
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	footnote162 Submitted by user on Fri, 03/15/2019 - 14:29 Negative 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	footnote162 Submitted by user on Fri, 03/15/2019 - 14:29 Negative 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	footnote162 Submitted by user on Fri, 03/15/2019 - 14:29 Negative 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	footnote162 Submitted by user on Fri, 03/15/2019 - 14:29 Negative 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	footnote162 Submitted by user on Fri, 03/15/2019 - 14:29 Negative 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	footnote162 Submitted by user on Fri, 03/15/2019 - 14:29 Negative 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	footnote162 Submitted by user on Fri, 03/15/2019 - 14:29 Negative 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	footnote162 Submitted by user on Fri, 03/15/2019 - 14:29 Negative 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	footnote162 Submitted by user on Fri, 03/15/2019 - 14:29 Negative 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	footnote162 Submitted by user on Fri, 03/15/2019 - 14:29 Negative 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	footnote162 Submitted by user on Fri, 03/15/2019 - 14:29 Negative 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	footnote162 Submitted by user on Fri, 03/15/2019 - 14:29 Negative 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	footnote162 Submitted by user on Fri, 03/15/2019 - 14:29 Negative 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	footnote162 Submitted by user on Fri, 03/15/2019 - 14:29 Negative 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	footnote162 Submitted by user on Fri, 03/15/2019 - 14:29 Negative 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 &#37 = 16.88	Adjusted mean % = 20.02	OR = 0.71	HomeVEE calculated = -0.13	Not statistically significant, p ≥ 0.05	footnote162 Submitted by user on Fri, 03/15/2019 - 14:29 Negative 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 &#37 = 25.77	Adjusted mean % = 21.55	OR = 1.14	HomeVEE calculated = 0.14	Not statistically significant, p ≥ 0.05	footnote162 Submitted by user on Fri, 03/15/2019 - 14:29 Negative 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 &#37 = 17.92	Adjusted mean % = 17.81	OR = 0.80	HomeVEE calculated = 0.00	Not statistically significant, p ≥ 0.05	footnote162 Submitted by user on Fri, 03/15/2019 - 14:29 Negative 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 &#37 = 27.74	Adjusted mean % = 30.78	OR = 0.76	HomeVEE calculated = -0.09	Not statistically significant, p ≥ 0.05	footnote162 Submitted by user on Fri, 03/15/2019 - 14:29 Negative 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 &#37 = 38.93	Adjusted mean % = 34.64	OR = 1.07	HomeVEE calculated = 0.11	Not statistically significant, p ≥ 0.05	footnote162 Submitted by user on Fri, 03/15/2019 - 14:29 Negative 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 &#37 = 32.91	Adjusted mean % = 29.11	OR = 1.04	HomeVEE calculated = 0.11	Not statistically significant, p ≥ 0.05	footnote162 Submitted by user on Fri, 03/15/2019 - 14:29 Negative 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 &#37 = 22.89	Adjusted mean % = 21.92	OR = 0.93	HomeVEE calculated = 0.03	Not statistically significant, p ≥ 0.05	footnote162 Submitted by user on Fri, 03/15/2019 - 14:29 Negative 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 &#37 = 21.34	Adjusted mean % = 21.90	OR = 0.83	HomeVEE calculated = -0.02	Not statistically significant, p ≥ 0.05	footnote162 Submitted by user on Fri, 03/15/2019 - 14:29 Negative 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 &#37 = 20.63	Adjusted mean % = 21.02	OR = 0.87	HomeVEE calculated = -0.01	Not statistically significant, p ≥ 0.05	footnote162 Submitted by user on Fri, 03/15/2019 - 14:29 Negative 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 &#37 = 12.39	Adjusted mean % = 18.83	OR = 0.57	HomeVEE calculated = -0.30	Not statistically significant, p ≥ 0.05	footnote162 Submitted by user on Fri, 03/15/2019 - 14:29 Negative 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 &#37 = 18.91	Adjusted mean % = 19.65	OR = 0.83	HomeVEE calculated = -0.03	Not statistically significant, p ≥ 0.05	footnote162 Submitted by user on Fri, 03/15/2019 - 14:29 Negative value is favorable to the intervention.

Positive parenting practices
Rating	Outcome measure	Effect	Sample	Timing of follow-up	Sample size	Intervention group	Comparison group	Group difference	Effect size	Statistical significance	Notes
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	footnote162 Submitted by user on Fri, 03/15/2019 - 14:29 Negative 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	footnote162 Submitted by user on Fri, 03/15/2019 - 14:29 Negative 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

Child development and school readiness
Outcome measure	Description of measure	Data collection method	Properties of measure
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

Maternal health
Outcome measure	Description of measure	Data collection method	Properties of measure
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

Positive parenting practices
Outcome measure	Description of measure	Data collection method	Properties of measure
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