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Barlow, A., Mullany, B., Neault, N., Goklish, N., Billy, T., Hastings, R., ... Walkup, J. T. (2015). Paraprofessional-delivered home-visiting intervention for American Indian teen mothers and children: 3-Year outcomes from a randomized controlled trial. American Journal of Psychiatry, 172(2), 154-162.

Model(s) Reviewed: Family Spirit®
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, SES, and outcome measures assessable at baseline None None
Notes:

footnote220

Submitted by user on Fri, 03/15/2019 - 14:29

Child outcomes (Infant-Toddler Social Emotional Assessment) rated moderate for this study, because of high attrition. Through communication with the first author, we established that the mothers of children in the child outcomes sample were equivalent at baseline on race/ethnicity and <abbr title="socioeconomic status">SES</abbr>; the child outcomes themselves were not assessable at baseline because the sample enrolled prenatally.

Study Characteristics
Study Participants Between 2006 and 2008, expectant women who were at less than or equal to 32 weeks gestation, aged 12-19 at conception, self-identified as American-Indian, and residing in one of the four participating reservation communities, were recruited into the study. Eligible participants were randomized by site, age, and history of previous live births. The sample sizes for the maternal parenting and health outcomes were as follows: analytic sample: 322 (159 T and 163 C)baseline sample: 322 (159 T and 163 C). Note: the study does not use a consistent analytic sample across different outcomes. The sample sizes shown here are relevant for maternal outcomes only. Sample sizes for child outcomes differ.
Setting Four southwestern reservation communities
Intervention Services The Family Spirit intervention consisted of 43 lessons delivered by Native American para-professionals from within participating communities. The lessons focused on parenting skills and maternal behavioral and psychosocial risks. The lessons were conducted in each participant's home and the visits lasted approximately one hour each. The visits occurred weekly through pregnancy, biweekly until 4 months postpartum, monthly between 4-12 months postpartum, and bimonthly between 12-36 months postpartum.
Comparison Conditions Optimized Standard Care consisted of transportation to recommended prenatal and well-baby clinic visits, pamphlets about childcare and community resources, and referrals to local services.
Staff Characteristics and Training Training and staff characteristics are not described.
Funding Sources Supported by National Institute on Drug Abuse grant R01 DA-019042 (principal investigator, J. Walkup).
Author Affiliation The corresponding author is one of the program developers.
Study Registration:
Clinicaltrials.gov Identifier: NCT00373750. Study registration was assessed by HomVEE beginning with the 2014 review.

Findings Details

Outcome Domain: Maternal Health
Rating Outcome Measure Effect Sample Timing of Follow-Up Sample Size Intervention Group Comparison Group Group Difference Effect Size Statistical Significance Outcome Type Notes
High ASEBA Externalizing (T-score)
FavorableUnfavorable or ambiguousNo Effect
Full 2006-2008 sample, 3 years postpartum 322 mothers Adjusted mean = 41.35 Adjusted mean = 42.58 Mean difference = -1.23 Study reported = 0.14 Statistically significant, p = 0.05 Primary

footnote162

Submitted by user on Fri, 03/15/2019 - 14:29

Negative value is favorable to the intervention.

High ASEBA Internalizing (T-score)
FavorableUnfavorable or ambiguousNo Effect
Full 2006-2008 sample, 3 years postpartum 322 mothers Adjusted mean = 42.89 Adjusted mean = 43.72 Mean difference = -0.83 Study reported = 0.09 Not statistically significant, p = 0.22 Primary

footnote162

Submitted by user on Fri, 03/15/2019 - 14:29

Negative value is favorable to the intervention.

High ASEBA Total Problems (T-score)
FavorableUnfavorable or ambiguousNo Effect
Full 2006-2008 sample, 3 years postpartum 322 mothers Adjusted mean = 40.51 Adjusted mean = 41.36 Mean difference = -0.86 Study reported = 0.10 Not statistically significant, p = 0.18 Primary

footnote162

Submitted by user on Fri, 03/15/2019 - 14:29

Negative value is favorable to the intervention.

High CES-D score (0-60)
FavorableUnfavorable or ambiguousNo Effect
Full 2006-2008 sample, 3 years postpartum 322 mothers Adjusted mean = 12.48 Adjusted mean = 13.65 Mean difference = -1.17 Study reported = 0.16 Statistically significant, p = 0.01 Secondary

footnote162

Submitted by user on Fri, 03/15/2019 - 14:29

Negative value is favorable to the intervention.

High Alcohol use in past 30 days (proportion)
FavorableUnfavorable or ambiguousNo Effect
Full 2006-2008 sample, 3 years postpartum 322 mothers Unadjusted mean = 0.17 Unadjusted mean = 0.16 Mean difference = 0.01 HomeVEE calculated = 0.04 Not statistically significant, p = 0.67 Secondary

footnote183

Submitted by user on Fri, 03/15/2019 - 14:29

Lower values favor the intervention

High Any illegal drug use in past 30 days (proportion)
FavorableUnfavorable or ambiguousNo Effect
Full 2006-2008 sample, 3 years postpartum 322 mothers Unadjusted mean = 0.12 Unadjusted mean = 0.17 Mean difference = -0.05 HomeVEE calculated = -0.24 Statistically significant, p = 0.01 Secondary

footnote183

Submitted by user on Fri, 03/15/2019 - 14:29

Lower values favor the intervention

High Marijuana use in past 30 days (proportion)
FavorableUnfavorable or ambiguousNo Effect
Full 2006-2008 sample, 3 years postpartum 322 mothers Unadjusted mean = 0.11 Unadjusted mean = 0.16 Mean difference = -0.05 HomeVEE calculated = -0.26 Statistically significant, p = 0.01 Secondary

footnote183

Submitted by user on Fri, 03/15/2019 - 14:29

Lower values favor the intervention

High Parenting stress index (range 0-180)
FavorableUnfavorable or ambiguousNo Effect
Full 2006-2008 sample, 3 years postpartum 322 mothers Adjusted mean = 75.53 Adjusted mean = 79.10 Mean difference = -3.57 Study reported = 0.18 Not statistically significant, p = 0.10 Primary

footnote162

Submitted by user on Fri, 03/15/2019 - 14:29

Negative value is favorable to the intervention.

Outcome Domain: 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 Outcome Type Notes
Moderate ITSEA Competence domain (proportion clinically at risk (>10%))
FavorableUnfavorable or ambiguousNo Effect
Children with ITSEA data 2006-2008 sample, 3 years postpartum 288 children Unadjusted mean = 0.24 Unadjusted mean = 0.23 Mean difference = 0.01 HomeVEE calculated = 0.03 Not statistically significant, p = 0.78 Primary
Moderate ITSEA Dysregulation domain (proportion clinically at risk (>10%))
FavorableUnfavorable or ambiguousNo Effect
Children with ITSEA data 2006-2008 sample, 3 years postpartum 288 children Unadjusted mean = 0.10 Unadjusted mean = 0.15 Mean difference = -0.04 HomeVEE calculated = -0.23 Not statistically significant, p = 0.08 Primary

footnote162

Submitted by user on Fri, 03/15/2019 - 14:29

Negative value is favorable to the intervention.

Moderate ITSEA Externalizing domain (proportion clinically at risk (>10%))
FavorableUnfavorable or ambiguousNo Effect
Children with ITSEA data 2006-2008 sample, 3 years postpartum 288 children Unadjusted mean = 0.17 Unadjusted mean = 0.24 Mean difference = -0.07 HomeVEE calculated = -0.24 Statistically significant, p = 0.03 Primary

footnote162

Submitted by user on Fri, 03/15/2019 - 14:29

Negative value is favorable to the intervention.

Moderate ITSEA Internalizing domain (proportion clinically at risk (>10%))
FavorableUnfavorable or ambiguousNo Effect
Children with ITSEA data 2006-2008 sample, 3 years postpartum 288 children Unadjusted mean = 0.10 Unadjusted mean = 0.15 Mean difference = -0.05 HomeVEE calculated = -0.27 Statistically significant, p = 0.04 Primary

footnote162

Submitted by user on Fri, 03/15/2019 - 14:29

Negative value is favorable to the intervention.

Moderate ITSEA mean, Competence domain (range 0-2)
FavorableUnfavorable or ambiguousNo Effect
Children with ITSEA data 2006-2008 sample, 3 years postpartum 288 children Adjusted mean = 1.28 Adjusted mean = 1.24 Mean difference = 0.04 Study reported = 0.14 Not statistically significant, p = 0.09 Primary
Moderate ITSEA mean, Dysregulation domain (range 0-2)
FavorableUnfavorable or ambiguousNo Effect
Children with ITSEA data 2006-2008 sample, 3 years postpartum 288 children Adjusted mean = 0.48 Adjusted mean = 0.55 Mean difference = -0.07 Study reported = 0.27 Statistically significant, p < .001 Primary

footnote162

Submitted by user on Fri, 03/15/2019 - 14:29

Negative value is favorable to the intervention.

Moderate ITSEA mean, Externalizing domain (range 0-2)
FavorableUnfavorable or ambiguousNo Effect
Children with ITSEA data 2006-2008 sample, 3 years postpartum 288 children Adjusted mean = 0.64 Adjusted mean = 0.71 Mean difference = -0.07 Study reported = 0.23 Statistically significant, p < .01 Primary

footnote162

Submitted by user on Fri, 03/15/2019 - 14:29

Negative value is favorable to the intervention.

Moderate ITSEA mean, Internalizing domain (range 0-2)
FavorableUnfavorable or ambiguousNo Effect
Children with ITSEA data 2006-2008 sample, 3 years postpartum 288 children Adjusted mean = 0.54 Adjusted mean = 0.60 Mean difference = -0.05 Study reported = 0.23 Statistically significant, p < .01 Primary

footnote162

Submitted by user on Fri, 03/15/2019 - 14:29

Negative value is favorable to the intervention.

Outcome Domain: Positive Parenting Practices
Rating Outcome Measure Effect Sample Timing of Follow-Up Sample Size Intervention Group Comparison Group Group Difference Effect Size Statistical Significance Outcome Type Notes
High HOME inventory (range 0-37)
FavorableUnfavorable or ambiguousNo Effect
Full 2006-2008 sample, 3 years postpartum 322 mothers Adjusted mean = 31.73 Adjusted mean = 31.63 Mean difference = 0.10 Study reported = 0.02 Not statistically significant, p = 0.77 Primary
High Parenting knowledge (range 0-30)
FavorableUnfavorable or ambiguousNo Effect
Full 2006-2008 sample, 3 years postpartum 322 mothers Adjusted mean = 15.94 Adjusted mean = 14.66 Mean difference = 1.28 Study reported = 0.42 Statistically significant, p < .001 Secondary
High Parenting locus of control (range 27-135)
FavorableUnfavorable or ambiguousNo Effect
Full 2006-2008 sample, 3 years postpartum 322 mothers Adjusted mean = 64.34 Adjusted mean = 66.03 Mean difference = -1.69 Study reported = 0.17 Statistically significant, p = 0.02 Secondary

footnote162

Submitted by user on Fri, 03/15/2019 - 14:29

Negative value is favorable to the intervention.

Outcome Measure Summary

Outcome Domain: Maternal Health
Rating Outcome Measure Description of Measure Data Collection Method Properties of Measure Outcome Type Link to delete Content
High

ASEBA Externalizing (T-score)

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

a = 0.90 for overall scale

Primary
High

ASEBA Internalizing (T-score)

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

a = 0.90 for overall scale

Primary
High

ASEBA Total Problems (T-score)

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

a = 0.90 for overall scale

Primary
High

CES-D score (0-60)

Center for Epidemiological Studies Depression is a 20-item assessment of depressive symptoms Maternal self-report

a = 0.84

Secondary
High

Alcohol use in past 30 days (proportion)

Proportion with use as measured by Voices for Indian Teens, a culturally specific assessment that measures quantity and frequency of substance use Maternal self-report

a = 0.73 for overall scale

Secondary
High

Any Illegal Drug use in past 30 days (proportion)

Proportion with use as measured by Voices for Indian Teens, a culturally specific assessment that measures quantity and frequency of substance use Maternal self-report

a = 0.73 for overall scale

Secondary
High

Marijuana use in past 30 days (proportion)

Proportion with use as measured by Voices for Indian Teens, a culturally specific assessment that measures quantity and frequency of substance use Maternal self-report

a = 0.73 for overall scale

Secondary
High

Parenting stress index (range 0-180)

36-item assessment of parenting-related stress, for which scoring norms are available by child age Maternal self-report

a = 0.94

Primary
Outcome Domain: Child Development and School Readiness
Rating Outcome Measure Description of Measure Data Collection Method Properties of Measure Outcome Type Link to delete Content
Moderate

ITSEA Competence domain (proportion clinically at risk (>10%))

Proportion clinically at risk on subscale from 126 item normed assessment of child behaviors, the Infant Toddler Social Emotional Assessment Maternal report

a = 0.89 for subscale

Primary
Moderate

ITSEA Dysregulation domain (proportion clinically at risk (>10%))

Proportion clinically at risk on subscale from 126 item normed assessment of child behaviors, the Infant Toddler Social Emotional Assessment Maternal report

a = 0.89 for subscale

Primary
Moderate

ITSEA Externalizing domain (proportion clinically at risk (>10%))

Proportion clinically at risk on subscale from 126 item normed assessment of child behaviors, the Infant Toddler Social Emotional Assessment Maternal report

a = 0.84 for subscale

Primary
Moderate

ITSEA Internalizing domain (proportion clinically at risk (>10%))

Proportion clinically at risk on subscale from 126 item normed assessment of child behaviors, the Infant Toddler Social Emotional Assessment Maternal report

a = 0.80 for subscale

Primary
Moderate

ITSEA mean, Competence domain (range 0-2)

Subscale from 126 item normed assessment of child behaviors, the Infant Toddler Social Emotional Assessment Maternal report

a = 0.89 for subscale

Primary
Moderate

ITSEA mean, Dysregulation domain (range 0-2)

Subscale from 126 item normed assessment of child behaviors, the Infant Toddler Social Emotional Assessment Maternal report

a = 0.89 for subscale

Primary
Moderate

ITSEA mean, Externalizing domain (range 0-2)

Subscale from 126 item normed assessment of child behaviors, the Infant Toddler Social Emotional Assessment Maternal report

a = 0.84 for subscale

Primary
Moderate

ITSEA mean, Internalizing domain (range 0-2)

Subscale from 126 item normed assessment of child behaviors, the Infant Toddler Social Emotional Assessment Maternal report

a = 0.80 for subscale

Primary
Outcome Domain: Positive Parenting Practices
Rating Outcome Measure Description of Measure Data Collection Method Properties of Measure Outcome Type Link to delete Content
High

HOME inventory (range 0-37)

37-item assessment of parental behavior, parent-child interaction, and home environment (maternal acceptance subscale was omitted) Researcher observation

a = 0.73

Primary
High

Parenting knowledge (range 0-30)

30-item assessment created by the investigator team to measure knowledge gains Maternal self-report

a = 0.58

Secondary
High

Parenting locus of control (range 27-135)

27-item assessment of parent self-efficacy, parent control, and child control Maternal self-report

a = 0.84

Secondary