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®
| Screening decision | Screening conclusion | HomVEE procedures and standards version |
|---|---|---|
| Passes screens | Eligible for review | Version 1 |
| Rating | Design | Attrition | Baseline equivalence | Compromised randomization | Confounding factors | Valid, reliable measure(s) |
|---|---|---|---|---|---|---|
| High | Randomized controlled trial | Low | Established on race, SES, and outcome measures assessable at baseline | None | None | Not assessed in manuscripts reviewed before 2021 |
Notes:
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 SES; the child outcomes themselves were not assessable at baseline because the sample enrolled prenatally.
| 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. |
| Subgroups examined |
This field lists subgroups examined in the manuscript (even if they were not replicated in other samples and not reported on the summary page for this model’s report). Subgroups are not listed for manuscripts reviewed before 2021. |
| 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. |
| Peer reviewed | Peer reviewed status is not listed for manuscripts reviewed before 2021. |
Study Registration:
Clinicaltrials.gov Identifier: NCT00373750. Study registration was assessed by HomVEE beginning with the 2014 review.
Findings that rate moderate or high
| Rating | Outcome measure | Effect | Sample | Timing of follow-up | Sample size | Intervention group | Comparison group | Group difference | Effect size | Statistical significance | 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 | HomVEE calculated = 0.03 | Not statistically significant, p = 0.78 | |
| 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 | HomVEE calculated = -0.23 | Not statistically significant, p = 0.08 | 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 | HomVEE calculated = -0.24 | Statistically significant, p = 0.03 | 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 | HomVEE calculated = -0.27 | Statistically significant, p = 0.04 | 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 | |
| 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 | 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 | 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 | Negative 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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 | 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 | 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 | 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 | HomVEE calculated = 0.04 | Not statistically significant, p = 0.67 | 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 | HomVEE calculated = -0.24 | Statistically significant, p = 0.01 | 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 | HomVEE calculated = -0.26 | Statistically significant, p = 0.01 | 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 | Negative 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | |
| 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 | |
| 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 | Negative value is favorable to the intervention.
|