Clinical trial NCT05729945: Catholic Health Initiatives (CHI) St. Joseph's Children Home Visiting Longitudinal Study
Official title: Catholic Health Initiatives (CHI) St. Joseph's Children Home Visiting Longitudinal Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Child Development
Child Behavior
Child Abuse
Child Neglect
Parenting
Delinquency
Criminal Behavior
Keywords: Home Visiting
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 343
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study involves a long-term outcome study of the Catholic Health Initiative St. Joseph's Children (CHI SJC) program using a randomized control study.

The purpose of this study is to determine the short-term and long-term impact and effectiveness of the CHI SJC program. The CHI SJC program has not been studied to determine program effectiveness. The investigators intend to follow families and their children until the children in the study graduate from high-school or turn 19 years of age.

The study, as a template, uses the eight outcome domains listed and described in the Home Visiting Evidence of Effectiveness website (http://homvee.acf.hhs.gov/outcomes.aspx). These eight domains are:

* Child development and school readiness
* Family economic self-sufficiency
* Maternal health
* Reductions in child maltreatment
* Child health
* Linkages and referrals
* Positive parenting practices
* Reductions in juvenile delinquency, family violence, and crime

The investigators expect to observe significant differences among the two groups with respect to the primary outcome domains listed. The investigators expect study group members randomized to the CHI SJC program will perform better on the eight outcome domains.

Other hypotheses include:

Other Hypotheses:

Hypothesis 1. Randomization to CHI SJC will be associated with higher quality functioning and better child health and well-being.

Hypothesis 2. Randomization to CHI SJC will result in more connections to community resources.

Hypothesis 3. Randomization to CHI SJC will result in improved indications of maternal health and positive parenting practices.

Hypothesis 4. Randomization to CHI SJC will be associated with higher measures of family economic self-sufficiency.

Hypothesis 5. Randomization to CHI SJC will be associated with increased school readiness and school progress and attainment.

Hypothesis 6. Randomization to CHI SJC will be associated with reductions in juvenile delinquency, family violence, and crime.

The study will collect outcome data in the same way and, at the same time, from treatment and control group members. Data collection will primarily be comprised of a set of self-report questionnaires and a review of administrative records that target the outcome domains described earlier. Study group members will be assessed at baseline, 6 months, 12 months, 18 months, 24 months, 3 years, 5 years, 8 years, 12 years, 15 years, and at high-school graduation or 19 years of age.


Eligibility criteria: Inclusion Criteria:

* Must be first-born child of one of the parents.
* Child must be 3-months of age or less at the time of enrollment.
* At the time of enrollment family must live within the 3 county area covered by the program.

Exclusion Criteria:

* Children older than 3-months.
* Children who are not the first-born child of one of the parents.

Primary outcomes:
measure: Child development and school readiness - Child Behavior Checklist (CBCL) to Measure Change at Time Frame Points
timeFrame: 5 years, 8 years, 12 years, 15 years
measure: Child Development and School Readiness - Ages and Stages Questionnaire (ASQ) to Measure Change at Time Frame Points
timeFrame: Birth/baseline, 6 months, 12 months, 18 months, 24 months, and 36 months
measure: Child Development and School Readiness - School Records to Measure Change at Time Frame Points
timeFrame: 5 years, 8 years, 12 years, and 15 years
measure: Maternal Health - Edinburgh Postnatal Depression Scale
timeFrame: Baseline/Birth
measure: Maternal Health - Brief Symptom Inventory
timeFrame: Baseline/Birth
measure: Maternal Health - CAGE-AID
timeFrame: Baseline/Birth
measure: Maternal Health - Program Administrative Records
timeFrame: Baseline/Birth
measure: Child Health - Program Administrative Records
timeFrame: Baseline/Birth
measure: Child Health - Adult Adolescent Parenting Inventory (AAPI-2) to Measure Change at Time Frame Points
timeFrame: Birth, 6 months, 12 months, 18 months, 24 months, 36 months, and 5 years
measure: Child Health - Modified Checklist for Autism in Toddlers (M-CHAT) to Measure Change at Time Frame Points
timeFrame: 6 months, 18 months, 24 months, and 36 months
measure: Child Health - Ages and Stages Questionnaire (ASQ) to Measure Change at Time Frame Points
timeFrame: Birth, 6 months, 12 months, 18 months, 24 months, 36 months
measure: Child Health - Abidin Parenting Stress Index Short Form (PSI-SF) to Measure Change at Time Frame Points
timeFrame: 6 month, 12 month, 18 month, 24 month, 36 month
measure: Child Maltreatment - Conflict Tactics Scale Parent-Child Form (CTS-PC) to Measure Change at Time Frame Points
timeFrame: 6 months, 12 months, 18 months, 24 months, 36 months, 5 years, 8 years, 12 years and 15 years
measure: Reduction in Child Maltreatment - Parenting Sense of Competence (PSOC) to Measure Change at Time Frame Points
timeFrame: 5 years, 8 years, 12 years and 15 years
measure: Reductions in Child Maltreatment - New Mexico Children, Youth and Families Department records to Measure Change at Time Frame Points
timeFrame: 6 months, 12 months, 18 months, 24 months, 36 months, 5 years, 8 years, 12 years, and 15 years
measure: Linkages and referrals - NM Human Services Department (HSD) records to Measure Change at Time Frame Points
timeFrame: Birth, 12 months, 18 months, 24 months, and 36 months
measure: Positive parenting practice - Brief Symptom Inventory
timeFrame: Baseline/Birth
measure: Positive Parenting Practices - Adult Adolescent Parenting Inventory (AAPI-2) to Measure Change at Time Frame Points
timeFrame: Birth, 6 months, 12 months, 18 months, 24 months, 36 months, and 5 years
measure: Family Economic Self-Sufficiency - N.M. Human Services Department (HSD)
timeFrame: Birth, 6 months, 12 months, 24 months, 36 months, 5 years, and 8 years
measure: Reductions in juvenile delinquency, family violence, and crime - Conflict Tactics Scale Parent-Child Form (CTS-PC)
timeFrame: 6 months, 12 months, 24 months, 36 months, 5 years, 8 years, 12 years, and 15 years
measure: Changes in juvenile delinquency, family violence, and crime - Jail data
timeFrame: 18 years up to 19 years
measure: Changes in juvenile delinquency, family violence, and crime - Law Enforcement records
timeFrame: 18 years up to 19 years
measure: Changes in juvenile delinquency, family violence, and crime - Court records
timeFrame: 18 years up to 19 years
measure: Changes in juvenile delinquency, family violence, and crime - Children, Youth and Families Department (CYFD) data
timeFrame: 8 years up to 18 years
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Paul Guerin, PhD
role: PRINCIPAL_INVESTIGATOR
References: