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Randomized clinical trial of Healthy Families Arizona home visiting program Craig W. LeCroy, Ph.D. LeCroy & Milligan Associates Arizona State University

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Page 1: Healthy Families Arizona - Prevent Child Abuse …preventchildabuse.org/wp-content/uploads/2016/10/HFAZ...Random Assignment Given a brochure and asked if they would be interested in

Randomized clinical trial of

Healthy Families Arizona home

visiting program

Craig W. LeCroy, Ph.D.

LeCroy & Milligan Associates

Arizona State University

Page 2: Healthy Families Arizona - Prevent Child Abuse …preventchildabuse.org/wp-content/uploads/2016/10/HFAZ...Random Assignment Given a brochure and asked if they would be interested in

Advice from the Children’s Bureau and

John Watson

“The care of a baby demands rigid discipline.”

“The rule that parents should not play with the baby

many seem hard, but it is without a doubt a safe one.”

“That is not to say that the baby should be left alone too

completely.”

-from Raising a baby the Government Way , M.Ladd Taylor, The psychological care of

the child and infant, J. Watson, 1928

2

Page 3: Healthy Families Arizona - Prevent Child Abuse …preventchildabuse.org/wp-content/uploads/2016/10/HFAZ...Random Assignment Given a brochure and asked if they would be interested in

History of bad parenting advice

Never hug or kiss your child.

Absolutely no night feedings.

Start potty training at 2 months of age.

Reduce colic by becoming less angry as a

mom.

Smear the baby in lard.

Page 4: Healthy Families Arizona - Prevent Child Abuse …preventchildabuse.org/wp-content/uploads/2016/10/HFAZ...Random Assignment Given a brochure and asked if they would be interested in
Page 5: Healthy Families Arizona - Prevent Child Abuse …preventchildabuse.org/wp-content/uploads/2016/10/HFAZ...Random Assignment Given a brochure and asked if they would be interested in

Issues in Healthy Families

Research Outcomes

Poor outcome results from previous studies

Page 6: Healthy Families Arizona - Prevent Child Abuse …preventchildabuse.org/wp-content/uploads/2016/10/HFAZ...Random Assignment Given a brochure and asked if they would be interested in

Poor Program Implementation

Page 7: Healthy Families Arizona - Prevent Child Abuse …preventchildabuse.org/wp-content/uploads/2016/10/HFAZ...Random Assignment Given a brochure and asked if they would be interested in

Limited Outcome Measures

Page 8: Healthy Families Arizona - Prevent Child Abuse …preventchildabuse.org/wp-content/uploads/2016/10/HFAZ...Random Assignment Given a brochure and asked if they would be interested in

Healthy Families Arizona Study

Page 9: Healthy Families Arizona - Prevent Child Abuse …preventchildabuse.org/wp-content/uploads/2016/10/HFAZ...Random Assignment Given a brochure and asked if they would be interested in

Random Assignment

Given a brochure and asked if they would be

interested in participating in a RCT

Randomly assigned to one of two groups

No interest – provided info on the program

Interested – Met eligibility?

Contacted by research staff

Page 10: Healthy Families Arizona - Prevent Child Abuse …preventchildabuse.org/wp-content/uploads/2016/10/HFAZ...Random Assignment Given a brochure and asked if they would be interested in

Contact with families

5 interviews over 3 years, each about 90 minutes

Baseline

Child 6 months of age

Child 1 year of age

Child age 2,

Child age 3

Page 11: Healthy Families Arizona - Prevent Child Abuse …preventchildabuse.org/wp-content/uploads/2016/10/HFAZ...Random Assignment Given a brochure and asked if they would be interested in

Study Objectives

1. Comparing the effectiveness of a home visitation

program (HFAz) and a treatment-as-usual control group on

primary social and behavioral outcomes.

2. Assessing maintenance of treatment gains by

conducting follow-up assessments.

3. Evaluating whether the home visitation program (HFAz)

has positive effects on a broad array of measures related

to program outcome.

Page 12: Healthy Families Arizona - Prevent Child Abuse …preventchildabuse.org/wp-content/uploads/2016/10/HFAZ...Random Assignment Given a brochure and asked if they would be interested in

Retention

Establishing a positive relationship

Removing all barriers to contact Accurate and thorough contact information for

participant and partner

Asking about plans about moving at each visit

Other contacts (at least two)

$10 incentive for reporting change of contact

Toll free number

Maintaining frequent contact

Page 13: Healthy Families Arizona - Prevent Child Abuse …preventchildabuse.org/wp-content/uploads/2016/10/HFAZ...Random Assignment Given a brochure and asked if they would be interested in

Study populationRisk Factors of Mothers Arizona Healthy

Families

Teen Births (19 years or

less)

16.4%

Births to Single Parents 66.3%

Less Than High School

Education

38.6%

Not Employed 78.7%

No Health Insurance 6.9%

Receives AHCCCS 82.5%

Late or No Prenatal Care 35.6%

Median Yearly Income $11,640

Risk Factors for Infants Arizona Healthy

Families

Born < 37 weeks gestation 15.6%

Birth Defects 0.9%

Low Birth Weight 13.2%

Positive Alcohol/Drug

Screen

9.4%

Page 14: Healthy Families Arizona - Prevent Child Abuse …preventchildabuse.org/wp-content/uploads/2016/10/HFAZ...Random Assignment Given a brochure and asked if they would be interested in

Retention in the study

Control Group

N = 147

Experimental

Group

N = 98

Baseline 147 100% 100* 100%

6-month 121 82% 78 78%

12-month 102 69% 65 65%

24-month 88 60% 50 50%

Page 15: Healthy Families Arizona - Prevent Child Abuse …preventchildabuse.org/wp-content/uploads/2016/10/HFAZ...Random Assignment Given a brochure and asked if they would be interested in

Baseline comparisonsDemographics Healthy Families Group Control Group Significance

White (n, %) 7 (7.2%) 22 (15.0%) nsHispanic (n, %) 72 (74.2%) 110 (74.8%) nsMother’s average age (Mean, SD) 26.9 (6.8) 25.8 (5.9) ns

Prenatal and birth characteristics

Birth weight (Mean, SD) 7.1 (1.5) 7.2 (1.3) nsN of Children before this birth (Mean,

SD)1.4 (1.5) 1.2 (1.2) ns

Smoked during pregnancy (n, %) 6 (6.2%) 11 (7.4%) nsAlcohol during pregnancy (n, %) 5 (5.2%) 8 (5.4%) nsAny prenatal care? (n, %) 95 (97.9%) 146 (98.6%) nsPrenatal care visits (Mean, SD) 12.8 (5.3) 13.1 (5.6) nsHigh School /GED? (n, %) 57 (58.8) 86 (58.1) nsMother employed (n, %) 21 (21.6%) 42 (28.4%) nsOwns a car (n, %) 43 (44.3%) 75 (50.7%) nsPartner (n, %) 80 (82.5) 131 (88.5) nsAHCCCS health insurance (n, %) 69 (71.6%) 92 (62.2%) ns

History of childhood maltreatment nsNeglected by caretakers (n, %) 20 (20.6%) 25 (16.9%) ns

Emotional abuse (n, %) 22 (22.7%) 38 (25.7%) nsSexual abuse (n, %) 12 (12.4%) 19 (12.8%) nsInvolvement with CPS as a parent (n, %) 12 (12.3%) 21(14.1%) ns

Page 16: Healthy Families Arizona - Prevent Child Abuse …preventchildabuse.org/wp-content/uploads/2016/10/HFAZ...Random Assignment Given a brochure and asked if they would be interested in

Outcomes

Safety practices

Parenting attitudes and practices

Health and maternal outcomes

Mental health and coping

Violent behavior

Page 17: Healthy Families Arizona - Prevent Child Abuse …preventchildabuse.org/wp-content/uploads/2016/10/HFAZ...Random Assignment Given a brochure and asked if they would be interested in
Page 18: Healthy Families Arizona - Prevent Child Abuse …preventchildabuse.org/wp-content/uploads/2016/10/HFAZ...Random Assignment Given a brochure and asked if they would be interested in

ScaleEffect size

(Cohen’s d)Significance

Safety scale .44 .003*

Electrical outlets .15 .08*

Locked poisons .17 .06*

Car seat .13 .10*

Poison Control .85 .01*

Healthy Families Significant Findings: Safety practices

Page 19: Healthy Families Arizona - Prevent Child Abuse …preventchildabuse.org/wp-content/uploads/2016/10/HFAZ...Random Assignment Given a brochure and asked if they would be interested in

ScaleEffect Size

(Cohen’s d)Significance

Regular routines .36 .01*

Reduced Chaotic household .29 .03*

Read to baby .31 .03*

Parenting competence .26 .08*

Parent/child behavior .24 .12

Home Environment .47 .003*

Parenting Efficacy .11 .12

Corporal punishment -.08 .24

Father Involvement .05 .73

Healthy Families Significant Findings: Parenting

Page 20: Healthy Families Arizona - Prevent Child Abuse …preventchildabuse.org/wp-content/uploads/2016/10/HFAZ...Random Assignment Given a brochure and asked if they would be interested in

ScaleEffect Size

(Cohen’s d)Significance

Breast feeding .29 .04*

Immunizations .04 .79

Well baby visits .06 .70

Contraception use .21(76% HF 66%

Control

Job

training/employment.09 .54

Healthy Families Significant Findings: Health and

Maternal Outcomes

Page 21: Healthy Families Arizona - Prevent Child Abuse …preventchildabuse.org/wp-content/uploads/2016/10/HFAZ...Random Assignment Given a brochure and asked if they would be interested in

ScaleEffect Size

(Cohen’s d)Significance

Goal Setting/future

orientation.26 .08*

Mental Health Index .44 .003*

Depression -.06 .34

Social Support .17 .26

Personal Care .14 .38

Emotional Loneliness .03 .84

Healthy Families Significant Findings: Mental Health

Page 22: Healthy Families Arizona - Prevent Child Abuse …preventchildabuse.org/wp-content/uploads/2016/10/HFAZ...Random Assignment Given a brochure and asked if they would be interested in

ScaleEffect Size

(Cohen’s d)Significance

Use of resources .214 .10*

Mobilizing Resources .43* .007*

Substance Abuse Treatment1 in HF group

1 in Control group

Early Intervention Services0 in Control group

2 in the HF group

Healthy Families Significant Findings:

Use of Resources

Page 23: Healthy Families Arizona - Prevent Child Abuse …preventchildabuse.org/wp-content/uploads/2016/10/HFAZ...Random Assignment Given a brochure and asked if they would be interested in

What didn’t show any

significance

Depression

Emotional loneliness

Immunizations

Well baby checks

Corporal Punishment

Page 24: Healthy Families Arizona - Prevent Child Abuse …preventchildabuse.org/wp-content/uploads/2016/10/HFAZ...Random Assignment Given a brochure and asked if they would be interested in

Linguistic analysis:

What our words say about us

Language—a new approach to studying

change.

“the words people generate are like

“fingerprints.”

Page 25: Healthy Families Arizona - Prevent Child Abuse …preventchildabuse.org/wp-content/uploads/2016/10/HFAZ...Random Assignment Given a brochure and asked if they would be interested in

Linguistic analysis-6 month

TREATMENT CONTROL P (d)

Past .94 (1.6) 1.65 (1.4) .10 (.27)*

Present 17.0 (5.8) 14.6 (5.5) .008 (.34)*

Future .18 (.77) .20 (.67) .81

First Person 3.7 (3.5) 3.3 (4.2) .60

Affective 17.4 (8.4) 15.0 (11.4) .15 (.24)*

Positive 15.3 (8.3) 12.0 (9.2) .02 (.37)*

Negative 1.9 (2.4) 2.8 (3.6) .08 (.29)*

Anxiety .20 (.74) .53 (2.9) .35

Page 26: Healthy Families Arizona - Prevent Child Abuse …preventchildabuse.org/wp-content/uploads/2016/10/HFAZ...Random Assignment Given a brochure and asked if they would be interested in

TREATMENT CONTROL P (d)

Anger .39 (1.1) .47 (1.4) .70

Sad .78 (1.3) 1.5 (2.0) .01 (.42)*

Perceptual

processes

4.2 (3.6) 2.9 (4.1) .04 (.33)*

Feeling

expression

1.6 (1.8) .77 (1.5) .002 (.50)*

Cognitive

mechanism

16.4 (6.5) 13.4 (7.2) .007 (.44)*

Insight 3.2 (3.1) 2.2 (3.0) .05 (.33)*

Cause 2.1 (2.3) 1.3 (1.8) .01 (.39)*

Certainty 1.4 (2.5) .82 (1.6) .08 (.27)*

Page 27: Healthy Families Arizona - Prevent Child Abuse …preventchildabuse.org/wp-content/uploads/2016/10/HFAZ...Random Assignment Given a brochure and asked if they would be interested in

Outcome Category Positive Findings

Safety Practices

Parenting

Health

Linkages/Referral

Mental Health

Home Environment

Overall Outcomes

Page 28: Healthy Families Arizona - Prevent Child Abuse …preventchildabuse.org/wp-content/uploads/2016/10/HFAZ...Random Assignment Given a brochure and asked if they would be interested in

ScaleEffect Size

(Cohen’s d)Significance

Use of resources .48 .01*

Mobilizing resources .47 .01*

Home environment .32 .04*

Subsequent pregnancy .25 .10*

Positive affect .35 .06*

Problem solving .19 .10*

One Year Outcomes

Page 29: Healthy Families Arizona - Prevent Child Abuse …preventchildabuse.org/wp-content/uploads/2016/10/HFAZ...Random Assignment Given a brochure and asked if they would be interested in

Linguistic analysis-12 month

Cohen’s d Significance

First Person .34 .001

Feeling

expression

.39 .02

Negative .54 .03

Cognitive

mechanism

.42 .02

Cause .50 .005

Page 30: Healthy Families Arizona - Prevent Child Abuse …preventchildabuse.org/wp-content/uploads/2016/10/HFAZ...Random Assignment Given a brochure and asked if they would be interested in

Violence in the home-12 month

Violence Healthy

Families

Mean

SD Control

Group

SD t-score p d

Shouted .06 (.24) .18 (.38) 2.38 .01* .37

Threaten

ed

.04 (.21) .10 (.31) 1.39 .16 .21**

Spanked .01 (.13) .05 (.23) 1.47 .14 .23**

Slapped .09 (.30) .11 (.32) .36 .71 .05

Total

Violence

.22 (.55) .46 (.97) 2.00 .04* .31

Page 31: Healthy Families Arizona - Prevent Child Abuse …preventchildabuse.org/wp-content/uploads/2016/10/HFAZ...Random Assignment Given a brochure and asked if they would be interested in

Overall Conclusions

Positive results across multiple domains-

Parenting and home environment showed some

of the best results

These are very direct indicators of the home

visitation program

Safety practices were positively impacted and

unintentional injuries are the leading cause of

death for children.

Indicators of violence found a less violent

household

Page 32: Healthy Families Arizona - Prevent Child Abuse …preventchildabuse.org/wp-content/uploads/2016/10/HFAZ...Random Assignment Given a brochure and asked if they would be interested in

Limitations/Research Issues

Some findings significant by chance.

Small sample size, especially at 12

months

Not a true control group—they received

some “active” aspects of the treatment

Page 33: Healthy Families Arizona - Prevent Child Abuse …preventchildabuse.org/wp-content/uploads/2016/10/HFAZ...Random Assignment Given a brochure and asked if they would be interested in
Page 34: Healthy Families Arizona - Prevent Child Abuse …preventchildabuse.org/wp-content/uploads/2016/10/HFAZ...Random Assignment Given a brochure and asked if they would be interested in

Craig W. LeCroy

[email protected]