Walkup 2009.

Study characteristics
Methods	Study design: RCT Study recruitment: May 2002–May 2004; follow‐up 12 months' postpartum Published protocol/trial: protocol not published and trial registered; NCT00356551
Participants	Description: pregnant American Indian adolescents aged 12–22 years at conception and at ≤ 28 weeks' gestation (intervention n = 81, control n = 86). Exclusion criteria: mothers were ineligible if they had extreme medical, legal, or social problems that precluded their ability to participate in visits or assessments; mothers who were at acute risk for self or others at the time of consent Indigenous population: Navajo and White Mountain Apache reservations in New Mexico and Arizona. Setting: USA, reservation Place of delivery: Indian Health Service Principle health condition: child behavioural health problems Age of mother: aged < 18 years: intervention 36 (44%), control 43 (50%) Gender of children born: not reported First child in family: intervention 73 (90%), control 78 (91%) Family unit: living with parents: intervention 63 (78%), control 58 (67%); married: intervention 9 (11%), control 5 (6%) Socioeconomic status: not reported Employment of mother: currently employed intervention: 9 (11%), control 11 (13%) Education of mother: high school/general equivalency diploma/some college: intervention 31 (38%), control 35 (41%)
Interventions	Intervention Intervention name: Family Spirit Intervention Intervention aim: to address antenatal and newborn care and maternal life skills Theory used to develop intervention: curricular content for the Family Spirit intervention was based on recommendations and standards documented in the American Academy of Pediatrics' Caring for Your Baby and Child: Birth to Age 5. This theoretical model hypothesises that parenting is the critical link between parent domains and child domains and mediates children's outcomes. Consumer and community involvement: the Navajo and White Mountain Apache leaders and community stakeholders contributed to the design of the intervention, research protocol, and reviewed the article. Overall grouping: education Fees, reimbursement, or incentives: incentives in the form of gift cards to a local grocery store were provided to participants on completion of study assessments. Procedures: curriculum included developmentally timed antenatal and infant‐care parenting lessons, as well as family planning, substance abuse prevention, and problem solving and coping‐skills lessons. The Family Spirit reflects local native practices but not community‐specific traditions or spiritual beliefs. Materials: none reported Mode of delivery: individual home visit or other private location When and how often was the intervention delivered? intervention was delivered from 28 weeks' gestation until 6 months' postpartum. 25 home visits were available each lasting approximately 1 hour. Who delivered the intervention? interventionists: local American Indian women from the community, bilingual, at least a high school degree and had work experience in health and human services Was there any training provided to the people who delivered the intervention? interventionists delivered both the intervention and control interventions to mothers. They received approximately 500 hours of training in home‐visiting methods and curricular content and demonstrating mastery and fidelity to the study protocol on oral and written examinations. Interventionists also served as evaluators and were specifically trained to administer self‐report and observational assessments with objectivity. Was the study modified or adapted? none reported Was the fidelity assessed? dose of intervention and control groups were collected. Treatment group mothers completed a median of 20/25 (80%) expected home visits. Control group mothers completed a median of 21/23 (91%) expected home visits (p. 598). Comparison Breastfeeding Nutrition Group Education programme. Control group's curricular content included a previously developed breastfeeding/nutrition education programme that included 23 home visits, each lasting approximately 1 hour. Fees, reimbursement, or incentives: gift cards to a local grocery store on completion of study assessments.
Outcomes	Overall health and well‐being: ITSEA – Competence domain Child psychological health and emotional behaviour: ITSEA – Competence domain Family enhancing lifestyle or behaviour outcomes: Home Observation for Measurement of the Environment Parent carer psychological health: depression Parenting knowledge and awareness: involvement Time points: 12 months' postpartum
Funding source and conflicts of interest	Funding: Substance Abuse Mental Health Services Administration (SAMHSA I: Grant No. UD1SP08860, SAMHSA II: Grant No. UD1SP09588), and the Ford Foundation, the Annie E. Casey Foundation, and the C.S. Mott Foundation. Conflict of interest: Dr Walkup has received research grant support from Eli Lilly, Pfizer, and Abbott. He has been a consultant to GlaxoSmithKline, Eli Lilly, and the Cliff 's Communities. He has received speaker's honoraria from the Tourette Syndrome Association. The other authors report no conflicts of interest.
Notes	Other outcomes collected but not used within the review Maternal outcomes: parenting knowledge, parenting stress, substance use, social support Time points not used: 6 months' postpartum
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation using web program Quote: "The randomization sequence, generated by the Website http://randomization.com was stored confidentially by the data manager in Baltimore, MD."
Allocation concealment (selection bias)	Low risk	Randomisation occurred after enrolment; central allocation was used. Quote: "Randomization was revealed to participants after the baseline assessment."
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants and people delivering the intervention were not blinded to the intervention. Quote: "Neither the participants nor the interventionists were blind to study group assignment."
Blinding of outcome assessment (detection bias) All outcomes	High risk	People who delivered the intervention also collected data. Quote: "Interventionists also served as evaluators and were specifically trained to administer self‐report and observational assessments with objectivity."
Incomplete outcome data (attrition bias) All outcomes	High risk	Intention‐to‐treat analysis completed. There was a high number of missing data by the end of the trial. In addition, the intervention group consistently had increased proportions of attrition at 2 and 6 months.
Selective reporting (reporting bias)	High risk	Trial was registered with no information provided on analysis. Only reported adjusted results and it was unclear how many confounders were included in the analysis.
Other bias	Unclear risk	There is some discussion on the cultural appropriateness of the outcomes in particular the Home Observation Measurement of the Environment outcome.

AG: anticipatory guidance; BMI: body mass index; FSN: Family Spirit Nurture; FV: fluoride varnish; HCSF: Healthy Child, Strong Families; ITSEA: Infant‐Toddler Social and Emotional Assessment; MI: motivational interviewing; n: number; RCT: randomised controlled trial; SD: standard deviation; SE: standard error; SF‐12: 12‐item Short Form Survey; SSB: sugar‐sweetened beverage; USD: US dollars.