Child DevelopmentNCT05729945
Catholic Health Initiatives (CHI) St. Joseph's Children Home Visiting Longitudinal Study
A study testing home visiting in people with Child Development and Child Behavior, run by University of New Mexico at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Child Development, Child Behavior, Child Abuse
- What is being tested?
- home visiting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 343 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2016to 5 Dec 2038
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 3 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Children older than 3-months.
- Children who are not the first-born child of one of the parents.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87131
About this study
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.
Read more
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.
- Conditions
- Child Development, Child Behavior, Child Abuse, Child Neglect, Parenting, Delinquency
- Being tested
- home visiting
- Keywords
- Home Visiting
- Medical subject headings
- Child Behavior, Criminal Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home visitingBehavioural
The intervention is a three year program that serves families and their first born children through home visiting using paraprofessionals to deliver a hybrid curriculum using the Partners for a Healthy Baby curriculum developed by Florida State University in January 2015.
| Study group | Role | What they receive |
|---|---|---|
| Home Visiting Group | Experimental | The home visiting group receives the program interventions which comprises home visits. Receives: Behavioral: home visiting |
| Business as Usual Group | No intervention | The control group is business as usual and does not receive the program intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child development and school readiness - Child Behavior Checklist (CBCL) to Measure Change at Time Frame Points
The CBCL is widely used to identify problem behavior in children. Problems are identified by a respondent who knows the child well, usually a parent or other caregiver. There are two versions of the checklist. The preschool checklist is intended for use with children aged 18 months to 5 years. The school-age version is for children aged 6 to 18 years. Administration takes 10 to 15 minutes. The checklist uses a 3 point scale (minimum 1 to maximum 3) with higher scores indicating a worse outcome.
The CBCL is made up of eight syndrome scales:
- anxious/depressed
- depressed
- somatic complaints
- social problems
- thought problems
- attention problems
- rule-breaking behavior
- aggressive behavior
These group into two higher order factors-internalizing and externalizing.
The 2001 revision added six DSM-oriented scales:
- affective problems
- anxiety problems
- somatic problems
- ADHD
- oppositional defiant problems
- conduct problems
Measured: 5 years, 8 years, 12 years, 15 years
Child Development and School Readiness - Ages and Stages Questionnaire (ASQ) to Measure Change at Time Frame Points
The Ages and Stages Questionnaires (ASQ) provide reliable, accurate developmental and social-emotional screening for children between birth and age 6. The ASQ is designed to pinpoint developmental progress and catch delays in young children. The core of the ASQ is 21 questionnaires, each with 30 items that correspond to age intervals from birth to 6 years. The ASQ has been validated in many countries and translated into numerous languages. The ASQ takes between 10 and 15 minutes to administer.
The parent-completed questionnaires are designed to screen the developmental performance of children in the areas of:
- communication,
- gross motor skills,
- fine motor skills,
- problem solving, and
- personal-social skills
The form uses a 3 point scale (minimum 1 to maximum 3) with lower scores indicating a worse outcome.
Measured: Birth/baseline, 6 months, 12 months, 18 months, 24 months, and 36 months
Child Development and School Readiness - School Records to Measure Change at Time Frame Points
Review of school records including standardized test scores, and grades. Standardized test scores, and grades will be combined to measure academic growth.
Measured: 5 years, 8 years, 12 years, and 15 years
Maternal Health - Edinburgh Postnatal Depression Scale
Maternal health will be measured using the Edinburgh Postnatal Depression Scale (EDPS). The EDPS is a 10 item questionnaire developed to identify women who may have postpartum depression. A very high EPDS score could suggest a crisis, other mental health issues or unresolved trauma.
The Edinburgh Postnatal Depression Scale is a widely used screening tool for postpartum depression. The form uses a 3-point scale (minimum 1 to maximum 3) and higher overall scores indicate depression.
Measured: Baseline/Birth
Maternal Health - Brief Symptom Inventory
The Brief Symptom Inventory (BSI), a brief psychological self-report symptom scale and will be used to measure maternal stress. The BSI is a 53-item questionnaire covering nine symptom dimensions of depression:
- Somatization
- Obsession-compulsion
- Interpersonal sensitivity
- Depression
- Anxiety
- Hostility
- Phobic anxiety
- Paranoid ideation
- Psychoticism
The BSI also includes three global indices of distress:
- Global Severity Index,
- Positive Symptom Distress Index, and
- Positive Symptom Total.
These measure number and intensity of reported symptoms, as well as the current or past level of symptomology. It can be administered in approximately 4 minutes. The BSI uses a 5-point rating scale (minimum 1 to maximum 5) with higher scores indicating a worse outcome.
Measured: Baseline/Birth
Maternal Health - CAGE-AID
The CAGE-AID is a validated substance abuse screening tool used to screen for alcohol and drug use and will be used to measure primary outcomes surrounding substance abuse. The CAGE-AID consists of 4 questions and takes one minute to administer. One or more positive answers to the CAGE-AID are considered a positive screen.
Measured: Baseline/Birth
Maternal Health - Program Administrative Records
Catholic Health Initiatives St. Joseph's Children (CHI SJC) administrative records for study group members collected by CHI SJC staff members, which include breastfeeding information, parent employment and education, and number of emergency room visits. These measures will be combined to measure maternal health.
Measured: Baseline/Birth
Child Health - Program Administrative Records
Catholic Health Initiatives St. Joseph's Children (CHI SJC) administrative records for study group members collected by CHI SJC staff members, which include breastfeeding information, parent employment and education, and number of emergency room visits. These measures will be combined to measure child health.
Measured: Baseline/Birth
Child Health - Adult Adolescent Parenting Inventory (AAPI-2) to Measure Change at Time Frame Points
The AAPI-2 is designed to assess the parenting and child-rearing attitudes of adolescents and adults and measures child health. It is a 40 item inventory with five subscales designed to assess the parenting and child-rearing attitudes of adult and adolescent parent and pre-parent populations. It takes, on average, between 10 and 15 minutes to complete. Scores range from 1-10 with lower scores indicating worse outcomes.
Responses to the AAPI-2 provide an index of risk in five specific parenting and child-rearing behaviors:
- Construct A - Expectations of Children
- Construct B - Empathy Towards Children's Needs
- Construct C - Use of Corporal Punishment as a Means of Discipline
- Construct D - Parent-Child Role Responsibilities
- Construct E - Children's Power and Independence
Adolescents as young as 13 years old can respond to the AAPI-2. The AAPI-2 is a validated and reliable inventory used to assess parenting attitudes.
Measured: Birth, 6 months, 12 months, 18 months, 24 months, 36 months, and 5 years
Child Health - Modified Checklist for Autism in Toddlers (M-CHAT) to Measure Change at Time Frame Points
The M-CHAT is designed to screen children aged 16 to 30 months for an autism spectrum disorder (ASD). The 23-item, parent-completed form generally takes 5 to 7 minutes to be completed and a brief time for staff to score. All items are scored as "yes"=1 or "no"=0 with higher scores indicating increased risk.
Measured: 6 months, 18 months, 24 months, and 36 months
Child Health - Ages and Stages Questionnaire (ASQ) to Measure Change at Time Frame Points
The Ages and Stages Questionnaires (ASQ) provide reliable, accurate developmental and social-emotional screening for children between birth and age 6. The ASQ is designed to pinpoint developmental progress and catch delays in young children. The core of the ASQ is 21 questionnaires, each with 30 items that correspond to age intervals from birth to 6 years. The ASQ has been validated in many countries and translated into numerous languages. The ASQ takes between 10 and 15 minutes to administer.
The parent-completed questionnaires are designed to screen the developmental performance of children in the areas of:
- communication,
- gross motor skills,
- fine motor skills,
- problem solving, and
- personal-social skills
The form uses a 3 point scale (minimum 1 to maximum 3) with lower scores indicating a worse outcome.
Measured: Birth, 6 months, 12 months, 18 months, 24 months, 36 months
Child Health - Abidin Parenting Stress Index Short Form (PSI-SF) to Measure Change at Time Frame Points
Child health will be assessed using the Abidin Parenting Stress Index Short Form (PSI-SF). The instrument is a well-validated 36 item measure of perceived stress in the parenting role with sound test-retest reliability and internal consistency. The PSI/SF yields a Total Stress score from three scales:
- Parental Distress,
- Parent-Child Dysfunctional Interaction, and
- Difficult Child.
Average time to complete is 10 minutes. Each item is rated on a 5 point scale (minimum 1 to maximum 5) with higher scores indicating more stress.
Measured: 6 month, 12 month, 18 month, 24 month, 36 month
Child Maltreatment - Conflict Tactics Scale Parent-Child Form (CTS-PC) to Measure Change at Time Frame Points
The CTS-PC is one of the most widely used instruments for identifying domestic violence and will be used to measure child maltreatment. The CTS-PC is a 35 item tool that is intended to measure psychological and physical maltreatment, and neglect of children by parents as well as non violent modes of discipline. Specifically, it measures if a parent has carried out acts of physical and psychological aggression, regardless of whether or not the child is injured. The assessment tool is a self-report measurement tool. The tool uses an 8-point scale (minimum 0 to maximum 7) with higher scores indicating greater conflict.
Measured: 6 months, 12 months, 18 months, 24 months, 36 months, 5 years, 8 years, 12 years and 15 years
Reduction in Child Maltreatment - Parenting Sense of Competence (PSOC) to Measure Change at Time Frame Points
The 17-item PSOC can be used to measure program outcomes, and, in other contexts, to measure a parent's level of perceived competence. It can also be used to measure satisfaction in parenting, and confidence in parenting efficacy individually, or as a combined total measure.
The PSOC was developed to assess parenting self-esteem using two rationally derived scales, as Efficacy and Satisfaction. The Efficacy factor examines the parents' competence, capability levels, and problem-solving abilities in their parental role; the Satisfaction factor examines the parents' anxiety, motivation and frustration. Average time to complete is less than 5 minutes. Each item is scored on a 6-point scale (minimum 1 to maximum 6) with higher scores equaling greater self-esteem.
Measured: 5 years, 8 years, 12 years and 15 years
Reductions in Child Maltreatment - New Mexico Children, Youth and Families Department records to Measure Change at Time Frame Points
New Mexico Children, Youth and Families Department (CYFD) data for any record of services received that include involvement in the Protective Services Division (PSD), early childhood services, or juvenile justice services. This includes abuse and neglect data. These measures will be combined to measure changes in child maltreatment at listed time frames.
Measured: 6 months, 12 months, 18 months, 24 months, 36 months, 5 years, 8 years, 12 years, and 15 years
Linkages and referrals - NM Human Services Department (HSD) records to Measure Change at Time Frame Points
Review of HSD records (i.e., SNAP, housing, medical, GED, etc.). These measures will be combined to measures linkages and referrals to community resources at listed time frames.
Measured: Birth, 12 months, 18 months, 24 months, and 36 months
Positive parenting practice - Brief Symptom Inventory
The Brief Symptom Inventory (BSI), a brief psychological self-report symptom scale and will be used to measure maternal stress. The BSI is a 53-item questionnaire covering nine symptom dimensions of depression:
- Somatization
- Obsession-compulsion
- Interpersonal sensitivity
- Depression
- Anxiety
- Hostility
- Phobic anxiety
- Paranoid ideation
- Psychoticism
The BSI also includes three global indices of distress:
- Global Severity Index,
- Positive Symptom Distress Index, and
- Positive Symptom Total.
These measure number and intensity of reported symptoms, as well as the current or past level of symptomology. It can be administered in approximately 4 minutes. The BSI uses a 5-point rating scale (minimum 1 to maximum 5) with higher scores indicating a worse outcome.
Measured: Baseline/Birth
Positive Parenting Practices - Adult Adolescent Parenting Inventory (AAPI-2) to Measure Change at Time Frame Points
The AAPI-2 is designed to assess the parenting and child-rearing attitudes of adolescents and adults and measures child health. It is a 40 item inventory with five subscales designed to assess the parenting and child-rearing attitudes of adult and adolescent parent and pre-parent populations. It takes, on average, between 10 and 15 minutes to complete. Scores range from 1-10 with lower scores indicating worse outcomes.
Responses to the AAPI-2 provide an index of risk in five specific parenting and child-rearing behaviors:
- Construct A - Expectations of Children
- Construct B - Empathy Towards Children's Needs
- Construct C - Use of Corporal Punishment as a Means of Discipline
- Construct D - Parent-Child Role Responsibilities
- Construct E - Children's Power and Independence
Adolescents as young as 13 years old can respond to the AAPI-2. The AAPI-2 is a validated and reliable inventory used to assess parenting attitudes.
Measured: Birth, 6 months, 12 months, 18 months, 24 months, 36 months, and 5 years
Family Economic Self-Sufficiency - N.M. Human Services Department (HSD)
Review of HSD records for public assistance (i.e., SNAP, housing, medical, GED, etc.) and program records of care-giver/parent reports of economic measures (i.e., SES, employment, education, use of community services, etc.), and family stability (i.e., relationship length, marital status, etc.).
Measured: Birth, 6 months, 12 months, 24 months, 36 months, 5 years, and 8 years
Reductions in juvenile delinquency, family violence, and crime - Conflict Tactics Scale Parent-Child Form (CTS-PC)
The CTS-PC is one of the most widely used instruments for identifying domestic violence and will be used to measure child maltreatment. The CTS-PC is a 35 item tool that is intended to measure psychological and physical maltreatment, and neglect of children by parents as well as non violent modes of discipline. Specifically, it measures if a parent has carried out acts of physical and psychological aggression, regardless of whether or not the child is injured. The assessment tool is a self-report measurement tool. The tool uses an 8-point scale (minimum 0 to maximum 7) with higher scores indicating greater conflict.
Measured: 6 months, 12 months, 24 months, 36 months, 5 years, 8 years, 12 years, and 15 years
Changes in juvenile delinquency, family violence, and crime - Jail data
Jail data for any booking records that includes the booking date, release date, and booking charges.
Measured: 18 years up to 19 years
Changes in juvenile delinquency, family violence, and crime - Law Enforcement records
Law enforcement data that will include the date of each arrest, whether the individual was transported to Jail or cited/summoned, and the arrest charges.
Measured: 18 years up to 19 years
Changes in juvenile delinquency, family violence, and crime - Court records
Public court records that include the filing of all criminal cases that will include the date of filing, charges, case closing date, and case disposition.
Measured: 18 years up to 19 years
Changes in juvenile delinquency, family violence, and crime - Children, Youth and Families Department (CYFD) data
CYFD data for any record of services received that include involvement in the Protective Services Division (PSD), early childhood services, or juvenile justice services.
Measured: 8 years up to 18 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start11 Oct 2016
- Primary completion4 Dec 2038 (estimated)
- Study completion5 Dec 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 343 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Guerin, PhD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729945
- Sponsor's protocol ID
- 2250030226
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2023
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catholic Health Initiatives (CHI) St. Joseph's Children Home Visiting Longitudinal Study
- ClinicalTrials.gov ID
- NCT05729945
- Acronym / sponsor ID
- 2250030226
- Conditions
- Child Development, Child Behavior, Child Abuse, Child Neglect, Parenting, Delinquency
- Keywords
- Home Visiting
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 343 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- 11 Oct 2016 (actual)
- Primary completion
- 4 Dec 2038 (estimated)
- Study completion
- 5 Dec 2038 (estimated)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home Visiting Group | Experimental | Behavioral: home visitingThe home visiting group receives the program interventions which comprises home visits. |
| Business as Usual Group | No intervention | –The control group is business as usual and does not receive the program intervention. |
Who may qualify
- Ages
- 1 month to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Children older than 3-months.
- Children who are not the first-born child of one of the parents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| home visitingThe intervention is a three year program that serves families and their first born children through home visiting using paraprofessionals to deliver a hybrid curriculum using the Partners for a Healthy Baby curriculum developed by Florida State University in January 2015. | Behavioural | Home Visiting Group |
Primary outcome
Child development and school readiness - Child Behavior Checklist (CBCL) to Measure Change at Time Frame Points
Time frame: 5 years, 8 years, 12 years, 15 years
The CBCL is widely used to identify problem behavior in children. Problems are identified by a respondent who knows the child well, usually a parent or other caregiver. There are two versions of the checklist. The preschool checklist is intended for use with children aged 18 months to 5 years. The school-age version is for children aged 6 to 18 years. Administration takes 10 to 15 minutes. The checklist uses a 3 point scale (minimum 1 to maximum 3) with higher scores indicating a worse outcome. The CBCL is made up of eight syndrome scales: * anxious/depressed * depressed * somatic complaints * social problems * thought problems * attention problems * rule-breaking behavior * aggressive behavior These group into two higher order factors-internalizing and externalizing. The 2001 revision added six DSM-oriented scales: * affective problems * anxiety problems * somatic problems * ADHD * oppositional defiant problems * conduct problems
Child Development and School Readiness - Ages and Stages Questionnaire (ASQ) to Measure Change at Time Frame Points
Time frame: Birth/baseline, 6 months, 12 months, 18 months, 24 months, and 36 months
The Ages and Stages Questionnaires (ASQ) provide reliable, accurate developmental and social-emotional screening for children between birth and age 6. The ASQ is designed to pinpoint developmental progress and catch delays in young children. The core of the ASQ is 21 questionnaires, each with 30 items that correspond to age intervals from birth to 6 years. The ASQ has been validated in many countries and translated into numerous languages. The ASQ takes between 10 and 15 minutes to administer. The parent-completed questionnaires are designed to screen the developmental performance of children in the areas of: 1. communication, 2. gross motor skills, 3. fine motor skills, 4. problem solving, and 5. personal-social skills The form uses a 3 point scale (minimum 1 to maximum 3) with lower scores indicating a worse outcome.
Child Development and School Readiness - School Records to Measure Change at Time Frame Points
Time frame: 5 years, 8 years, 12 years, and 15 years
Review of school records including standardized test scores, and grades. Standardized test scores, and grades will be combined to measure academic growth.
Maternal Health - Edinburgh Postnatal Depression Scale
Time frame: Baseline/Birth
Maternal health will be measured using the Edinburgh Postnatal Depression Scale (EDPS). The EDPS is a 10 item questionnaire developed to identify women who may have postpartum depression. A very high EPDS score could suggest a crisis, other mental health issues or unresolved trauma. The Edinburgh Postnatal Depression Scale is a widely used screening tool for postpartum depression. The form uses a 3-point scale (minimum 1 to maximum 3) and higher overall scores indicate depression.
Maternal Health - Brief Symptom Inventory
Time frame: Baseline/Birth
The Brief Symptom Inventory (BSI), a brief psychological self-report symptom scale and will be used to measure maternal stress. The BSI is a 53-item questionnaire covering nine symptom dimensions of depression: 1. Somatization 2. Obsession-compulsion 3. Interpersonal sensitivity 4. Depression 5. Anxiety 6. Hostility 7. Phobic anxiety 8. Paranoid ideation 9. Psychoticism The BSI also includes three global indices of distress: 1. Global Severity Index, 2. Positive Symptom Distress Index, and 3. Positive Symptom Total. These measure number and intensity of reported symptoms, as well as the current or past level of symptomology. It can be administered in approximately 4 minutes. The BSI uses a 5-point rating scale (minimum 1 to maximum 5) with higher scores indicating a worse outcome.
Maternal Health - CAGE-AID
Time frame: Baseline/Birth
The CAGE-AID is a validated substance abuse screening tool used to screen for alcohol and drug use and will be used to measure primary outcomes surrounding substance abuse. The CAGE-AID consists of 4 questions and takes one minute to administer. One or more positive answers to the CAGE-AID are considered a positive screen.
Maternal Health - Program Administrative Records
Time frame: Baseline/Birth
Catholic Health Initiatives St. Joseph's Children (CHI SJC) administrative records for study group members collected by CHI SJC staff members, which include breastfeeding information, parent employment and education, and number of emergency room visits. These measures will be combined to measure maternal health.
Child Health - Program Administrative Records
Time frame: Baseline/Birth
Catholic Health Initiatives St. Joseph's Children (CHI SJC) administrative records for study group members collected by CHI SJC staff members, which include breastfeeding information, parent employment and education, and number of emergency room visits. These measures will be combined to measure child health.
Child Health - Adult Adolescent Parenting Inventory (AAPI-2) to Measure Change at Time Frame Points
Time frame: Birth, 6 months, 12 months, 18 months, 24 months, 36 months, and 5 years
The AAPI-2 is designed to assess the parenting and child-rearing attitudes of adolescents and adults and measures child health. It is a 40 item inventory with five subscales designed to assess the parenting and child-rearing attitudes of adult and adolescent parent and pre-parent populations. It takes, on average, between 10 and 15 minutes to complete. Scores range from 1-10 with lower scores indicating worse outcomes. Responses to the AAPI-2 provide an index of risk in five specific parenting and child-rearing behaviors: * Construct A - Expectations of Children * Construct B - Empathy Towards Children's Needs * Construct C - Use of Corporal Punishment as a Means of Discipline * Construct D - Parent-Child Role Responsibilities * Construct E - Children's Power and Independence Adolescents as young as 13 years old can respond to the AAPI-2. The AAPI-2 is a validated and reliable inventory used to assess parenting attitudes.
Child Health - Modified Checklist for Autism in Toddlers (M-CHAT) to Measure Change at Time Frame Points
Time frame: 6 months, 18 months, 24 months, and 36 months
The M-CHAT is designed to screen children aged 16 to 30 months for an autism spectrum disorder (ASD). The 23-item, parent-completed form generally takes 5 to 7 minutes to be completed and a brief time for staff to score. All items are scored as "yes"=1 or "no"=0 with higher scores indicating increased risk.
Child Health - Ages and Stages Questionnaire (ASQ) to Measure Change at Time Frame Points
Time frame: Birth, 6 months, 12 months, 18 months, 24 months, 36 months
The Ages and Stages Questionnaires (ASQ) provide reliable, accurate developmental and social-emotional screening for children between birth and age 6. The ASQ is designed to pinpoint developmental progress and catch delays in young children. The core of the ASQ is 21 questionnaires, each with 30 items that correspond to age intervals from birth to 6 years. The ASQ has been validated in many countries and translated into numerous languages. The ASQ takes between 10 and 15 minutes to administer. The parent-completed questionnaires are designed to screen the developmental performance of children in the areas of: 1. communication, 2. gross motor skills, 3. fine motor skills, 4. problem solving, and 5. personal-social skills The form uses a 3 point scale (minimum 1 to maximum 3) with lower scores indicating a worse outcome.
Child Health - Abidin Parenting Stress Index Short Form (PSI-SF) to Measure Change at Time Frame Points
Time frame: 6 month, 12 month, 18 month, 24 month, 36 month
Child health will be assessed using the Abidin Parenting Stress Index Short Form (PSI-SF). The instrument is a well-validated 36 item measure of perceived stress in the parenting role with sound test-retest reliability and internal consistency. The PSI/SF yields a Total Stress score from three scales: 1. Parental Distress, 2. Parent-Child Dysfunctional Interaction, and 3. Difficult Child. Average time to complete is 10 minutes. Each item is rated on a 5 point scale (minimum 1 to maximum 5) with higher scores indicating more stress.
Child Maltreatment - Conflict Tactics Scale Parent-Child Form (CTS-PC) to Measure Change at Time Frame Points
Time frame: 6 months, 12 months, 18 months, 24 months, 36 months, 5 years, 8 years, 12 years and 15 years
The CTS-PC is one of the most widely used instruments for identifying domestic violence and will be used to measure child maltreatment. The CTS-PC is a 35 item tool that is intended to measure psychological and physical maltreatment, and neglect of children by parents as well as non violent modes of discipline. Specifically, it measures if a parent has carried out acts of physical and psychological aggression, regardless of whether or not the child is injured. The assessment tool is a self-report measurement tool. The tool uses an 8-point scale (minimum 0 to maximum 7) with higher scores indicating greater conflict.
Reduction in Child Maltreatment - Parenting Sense of Competence (PSOC) to Measure Change at Time Frame Points
Time frame: 5 years, 8 years, 12 years and 15 years
The 17-item PSOC can be used to measure program outcomes, and, in other contexts, to measure a parent's level of perceived competence. It can also be used to measure satisfaction in parenting, and confidence in parenting efficacy individually, or as a combined total measure. The PSOC was developed to assess parenting self-esteem using two rationally derived scales, as Efficacy and Satisfaction. The Efficacy factor examines the parents' competence, capability levels, and problem-solving abilities in their parental role; the Satisfaction factor examines the parents' anxiety, motivation and frustration. Average time to complete is less than 5 minutes. Each item is scored on a 6-point scale (minimum 1 to maximum 6) with higher scores equaling greater self-esteem.
Reductions in Child Maltreatment - New Mexico Children, Youth and Families Department records to Measure Change at Time Frame Points
Time frame: 6 months, 12 months, 18 months, 24 months, 36 months, 5 years, 8 years, 12 years, and 15 years
New Mexico Children, Youth and Families Department (CYFD) data for any record of services received that include involvement in the Protective Services Division (PSD), early childhood services, or juvenile justice services. This includes abuse and neglect data. These measures will be combined to measure changes in child maltreatment at listed time frames.
Linkages and referrals - NM Human Services Department (HSD) records to Measure Change at Time Frame Points
Time frame: Birth, 12 months, 18 months, 24 months, and 36 months
Review of HSD records (i.e., SNAP, housing, medical, GED, etc.). These measures will be combined to measures linkages and referrals to community resources at listed time frames.
Positive parenting practice - Brief Symptom Inventory
Time frame: Baseline/Birth
The Brief Symptom Inventory (BSI), a brief psychological self-report symptom scale and will be used to measure maternal stress. The BSI is a 53-item questionnaire covering nine symptom dimensions of depression: 1. Somatization 2. Obsession-compulsion 3. Interpersonal sensitivity 4. Depression 5. Anxiety 6. Hostility 7. Phobic anxiety 8. Paranoid ideation 9. Psychoticism The BSI also includes three global indices of distress: 1. Global Severity Index, 2. Positive Symptom Distress Index, and 3. Positive Symptom Total. These measure number and intensity of reported symptoms, as well as the current or past level of symptomology. It can be administered in approximately 4 minutes. The BSI uses a 5-point rating scale (minimum 1 to maximum 5) with higher scores indicating a worse outcome.
Positive Parenting Practices - Adult Adolescent Parenting Inventory (AAPI-2) to Measure Change at Time Frame Points
Time frame: Birth, 6 months, 12 months, 18 months, 24 months, 36 months, and 5 years
The AAPI-2 is designed to assess the parenting and child-rearing attitudes of adolescents and adults and measures child health. It is a 40 item inventory with five subscales designed to assess the parenting and child-rearing attitudes of adult and adolescent parent and pre-parent populations. It takes, on average, between 10 and 15 minutes to complete. Scores range from 1-10 with lower scores indicating worse outcomes. Responses to the AAPI-2 provide an index of risk in five specific parenting and child-rearing behaviors: * Construct A - Expectations of Children * Construct B - Empathy Towards Children's Needs * Construct C - Use of Corporal Punishment as a Means of Discipline * Construct D - Parent-Child Role Responsibilities * Construct E - Children's Power and Independence Adolescents as young as 13 years old can respond to the AAPI-2. The AAPI-2 is a validated and reliable inventory used to assess parenting attitudes.
Family Economic Self-Sufficiency - N.M. Human Services Department (HSD)
Time frame: Birth, 6 months, 12 months, 24 months, 36 months, 5 years, and 8 years
Review of HSD records for public assistance (i.e., SNAP, housing, medical, GED, etc.) and program records of care-giver/parent reports of economic measures (i.e., SES, employment, education, use of community services, etc.), and family stability (i.e., relationship length, marital status, etc.).
Reductions in juvenile delinquency, family violence, and crime - Conflict Tactics Scale Parent-Child Form (CTS-PC)
Time frame: 6 months, 12 months, 24 months, 36 months, 5 years, 8 years, 12 years, and 15 years
The CTS-PC is one of the most widely used instruments for identifying domestic violence and will be used to measure child maltreatment. The CTS-PC is a 35 item tool that is intended to measure psychological and physical maltreatment, and neglect of children by parents as well as non violent modes of discipline. Specifically, it measures if a parent has carried out acts of physical and psychological aggression, regardless of whether or not the child is injured. The assessment tool is a self-report measurement tool. The tool uses an 8-point scale (minimum 0 to maximum 7) with higher scores indicating greater conflict.
Changes in juvenile delinquency, family violence, and crime - Jail data
Time frame: 18 years up to 19 years
Jail data for any booking records that includes the booking date, release date, and booking charges.
Changes in juvenile delinquency, family violence, and crime - Law Enforcement records
Time frame: 18 years up to 19 years
Law enforcement data that will include the date of each arrest, whether the individual was transported to Jail or cited/summoned, and the arrest charges.
Changes in juvenile delinquency, family violence, and crime - Court records
Time frame: 18 years up to 19 years
Public court records that include the filing of all criminal cases that will include the date of filing, charges, case closing date, and case disposition.
Changes in juvenile delinquency, family violence, and crime - Children, Youth and Families Department (CYFD) data
Time frame: 8 years up to 18 years
CYFD data for any record of services received that include involvement in the Protective Services Division (PSD), early childhood services, or juvenile justice services.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Guerin, PhD principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing home visiting in people with Child Development and Child Behavior, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child development and school readiness - Child Behavior Checklist (CBCL) to Measure Change at Time Frame Points (time frame: 5 years, 8 years, 12 years, 15 years). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.