Families With InfantsNCT06941337
HealthySteps + PlayReadVIP
A study testing HealthySteps (HS) and PlayReadVIP in people with Families With Infants, run by NYU Langone Health at 1 site in United States.
Trial summary
This study aims to investigate the effectiveness and implementation outcomes for the integration of two evidence-based practices and interventions (EBPIs) within pediatric primary care settings: HealthySteps (HS), which provides parenting support, and PlayReadVIP, which promotes relational health through video… Read more about this study
- Who is it for?
- Ages Up to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Families With Infants
- What is being tested?
- HealthySteps (HS) and PlayReadVIP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2025to Jan 2029
- 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 Up to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parent is a biological parent or legal guardian and at least 18 years of age
- Infants must be ≤6 months old at the time of enrollment.
- Parents/guardians must speak either English or Spanish to ensure they can fully engage with the intervention and assessments.
- Families must be identified as Tier 3 HealthySteps participants, indicating higher levels of need based on clinic screening for factors such as:Adverse Childhood Experiences (ACEs) and parenting challenges or vulnerabilities.
- Parent is able to willing to provide consent for their own and their child's participation.
Who cannot join
- Non-singleton child
- Parent is unable to provide consent
- Parent does not speak English or Spanish, as study materials (e.g., questionnaires) are available in those languages
- Parent has a severe medical or psychiatric impairment (e.g., intellectual disability, psychosis) that would interfere with study participation
- Parent has plans to discontinue care at NYU Langone Health - Sunset Park Family Health Centers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Janae Kuttamperoor contact
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
Official title: HEALTHYSTEPS + PLAYREADVIP EFFECTS ON PARENTING AND CHILD DEVELOPMENT: A RANDOMIZED IMPLEMENTATION EFFECTIVENESS TRIAL
This study aims to investigate the effectiveness and implementation outcomes for the integration of two evidence-based practices and interventions (EBPIs) within pediatric primary care settings: HealthySteps (HS), which provides parenting support, and PlayReadVIP, which promotes relational health through video coaching. Families will be randomized to receive either the integrated HS + PlayReadVIP model or traditional HS, and investigators will examine impacts on parenting, parent-child relationships, and child development, as well as feasibility, acceptability, and appropriateness of the integrated intervention.
- Conditions
- Families With Infants
- Being tested
- HealthySteps (HS), PlayReadVIP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HealthySteps (HS)Behavioural
Evidence-based program that focuses on addressing Adverse Childhood Experiences (ACEs) and family stressors. The program provides parenting guidance, mental health support, and care coordination. The program is delivered during well-child visits by an HS specialist.
PlayReadVIPBehavioural
Evidence-based program that promotes Positive Childhood Experiences (PCEs) and strengthens parent-child interactions. The program involves recording and reviewing videos of parents engaging with their child to provide feedback and encourage positive practices. Families receive toys, books, and guides to extend activities at home.
| Study group | Role | What they receive |
|---|---|---|
| HealthySteps + PlayReadVIP | Experimental | Families (parent-child dyads) randomized to receive HealthySteps (HS), which provides parenting support, plus PlayReadVIP, which promotes relational health through video coaching. Receives: Behavioral: HealthySteps (HS); Behavioral: PlayReadVIP |
| Standard HealthySteps | Active comparator | Families (parent-child dyads) randomized to receive HealthySteps (HS), which provides parenting support, only. Receives: Behavioral: HealthySteps (HS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adult-Child Relationship Scale Score
13-item assessment of parent-child relationship quality. Each item is rated on a Likert 5 scale from 1 (definitely not) to 5 (definitely). The total score is the average of item responses and ranges from 1-5; higher scores indicate a stronger and more positive relationship between the child and parent.
Measured: Month 12
Adult-Child Relationship Scale Score
13-item assessment of parent-child relationship quality. Each item is rated on a Likert 5 scale from 1 (definitely not) to 5 (definitely). The total score is the average of item responses and ranges from 1-5; higher scores indicate a stronger and more positive relationship between the child and parent.
Measured: Month 24
Stimulation Questionnaire (StimQ) Core: Reading, Teaching, Verbal Responsivity Score
The StimQ is a parent-report measure of the cognitive home environment, designed to assess the level of cognitive stimulation children receive at home. Items include dichotomous (yes or no) and Likert-style responses ranging from 0-4. The total score is the sum of item responses and ranges from 0 to 43; higher scores are correlated with better parental behavior.
Measured: Month 12
Stimulation Questionnaire (StimQ) Core: Reading, Teaching, Verbal Responsivity Score
The StimQ is a parent-report measure of the cognitive home environment, designed to assess the level of cognitive stimulation children receive at home. Items include dichotomous (yes or no) and Likert-style responses ranging from 0-4. The total score is the sum of item responses and ranges from 0 to 43; higher scores are correlated with better parental behavior.
Measured: Month 24
Infant Behavior Questionnaire Score
36-item parent-report questionnaire used to measure the temperament of an infant (3-12 months old). Each item is rated on a scale from 1 (never) to 7 (always); the total score is the average of responses and ranges from 1-7; higher scores indicating greater frequency of behaviors.
Measured: Month 12
Brief Infant Toddler Social-Emotional Assessment (BITSEA) Score: Competence
BITSEA measures socioemotional development in toddlerhood. 11 of the items cover competence. Each item is rated on a scale from 0-2. The total BITSEA Competence Score is the sum of responses and ranges from 0-22; higher scores indicate greater functioning.
Measured: Month 12
Brief Infant Toddler Social-Emotional Assessment (BITSEA) Score: Problems
BITSEA measures socioemotional development in toddlerhood. 31 of the items cover problems. Each item is rated on a scale from 0-2. The total BITSEA Problems Score is the sum of responses and ranges from 0-62; higher scores indicate poorer functioning.
Measured: Month 12
Child Behavior Checklist Score
100-item questionnaire identifying problem behavior in children. Each item is rated on a scale from 0 (absent) to 2 (often occurs). The raw score is the sum of responses and is transformed into a final t-score ranging from 0-100 with a mean of 50 and standard deviation of 10. T-scores below 60 indicate non-clinical symptoms; t-scores between 60 and 64 indicate that the child is at risk for problem behaviors; and t-scores above 65 indicate clinical symptoms.
Measured: Month 24
Secondary outcomes (21)
Edinburgh Depression Scale (EPDS) Score
10-item screening tool used to assess symptoms of depression in pregnant and postpartum women. The total score is determined by adding together the scores for each of the 10 items and ranges from 0-30; higher scores indicate greater severity of depression.
Measured: Baseline
Edinburgh Depression Scale (EPDS) Score
10-item screening tool used to assess symptoms of depression in pregnant and postpartum women. The total score is determined by adding together the scores for each of the 10 items and ranges from 0-30; higher scores indicate greater severity of depression.
Measured: Month 12
Edinburgh Depression Scale (EPDS) Score
10-item screening tool used to assess symptoms of depression in pregnant and postpartum women. The total score is determined by adding together the scores for each of the 10 items and ranges from 0-30; higher scores indicate greater severity of depression.
Measured: Month 24
Perceived Stress Scale (PSS) Score
10-item assessment of stress over the past month. Each item is rated on a scale from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0-40; higher scores indicate more severe stress.
Measured: Baseline
Perceived Stress Scale (PSS) Score
10-item assessment of stress over the past month. Each item is rated on a scale from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0-40; higher scores indicate more severe stress.
Measured: Month 12
Perceived Stress Scale (PSS) Score
10-item assessment of stress over the past month. Each item is rated on a scale from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0-40; higher scores indicate more severe stress.
Measured: Month 24
Parenting Self-Agency Measure
5-item assessment of thoughts and feelings about being a parent. Each item is rated on a scale from 1 (almost never or never) to 5 (almost always or always). The total score ranges from 5-25; higher scores indicate greater parenting self-agency.
Measured: Baseline
Parenting Self-Agency Measure
5-item assessment of thoughts and feelings about being a parent. Each item is rated on a scale from 1 (almost never or never) to 5 (almost always or always). The total score ranges from 5-25; higher scores indicate greater parenting self-agency.
Measured: Month 12
Parenting Self-Agency Measure
5-item assessment of thoughts and feelings about being a parent. Each item is rated on a scale from 1 (almost never or never) to 5 (almost always or always). The total score ranges from 5-25; higher scores indicate greater parenting self-agency.
Measured: Month 24
Patient-Reported Outcomes Measurement Information System (PROMIS): General Life Satisfaction Scale Score
5-item questionnaire of life satisfaction. Responses are scored on a Likert scale and then converted to a T-score with a mean of 50 and a standard deviation of 10, where higher scores indicate greater satisfaction.
Measured: Baseline
PROMIS: General Life Satisfaction Scale Score
5-item questionnaire of life satisfaction. Responses are scored on a Likert scale and then converted to a T-score with a mean of 50 and a standard deviation of 10, where higher scores indicate greater satisfaction.
Measured: Month 12
PROMIS: General Life Satisfaction Scale Score
5-item questionnaire of life satisfaction. Responses are scored on a Likert scale and then converted to a T-score with a mean of 50 and a standard deviation of 10, where higher scores indicate greater satisfaction.
Measured: Month 24
Dyadic Adjustment Scale Score
32-item assessment of relationship quality of intact couples. Each item is rated on a scale; the total score is the sum of responses. Scores range from 0 to 151, with higher scores indicating greater relationship satisfaction and lower scores suggesting more distress.
Measured: Baseline
Dyadic Adjustment Scale Score
32-item assessment of relationship quality of intact couples. Each item is rated on a scale; the total score is the sum of responses. Scores range from 0 to 151, with higher scores indicating greater relationship satisfaction and lower scores suggesting more distress.
Measured: Month 12
Dyadic Adjustment Scale Score
32-item assessment of relationship quality of intact couples. Each item is rated on a scale; the total score is the sum of responses. Scores range from 0 to 151, with higher scores indicating greater relationship satisfaction and lower scores suggesting more distress.
Measured: Month 24
Socolar Discipline Survey Score
34-item questionnaire assessing how a parent handles their problems with their children's behavior over the past 3 months. Each item is rated on a scale from 1 (never) to 6 (always). The total score is the sum of responses and ranges from 34 to 204; higher scores indicate greater frequency of harsher discipline.
Measured: Month 12
Socolar Discipline Survey Score
34-item questionnaire assessing how a parent handles their problems with their children's behavior over the past 3 months. Each item is rated on a scale from 1 (never) to 6 (always). The total score is the sum of responses and ranges from 34 to 204; higher scores indicate greater frequency of harsher discipline.
Measured: Month 24
Early Social Communication Scale (ESCS) Score
The ESCS is a videotaped, structured observation measure designed to assess nonverbal communication skills in children. Frequency scores for initiation of joint attention (IJA) are derived from behavioral observations during a series of tasks. IJA score ranges from 0 to 100 where a higher value indicates greater initiation of joint attention.
Measured: Month 12
Early Social Communication Scale (ESCS) Score
The ESCS is a videotaped, structured observation measure designed to assess nonverbal communication skills in children. Frequency scores for initiation of joint attention (IJA) are derived from behavioral observations during a series of tasks. IJA score ranges from 0 to 100 where a higher value indicates greater initiation of joint attention.
Measured: Month 24
MacArthur-Bates Communicative Development Inventory (CDI) Score
Parent report instrument that measures early language development, including productive vocabulary. Parents mark each example of words that their child says. The total score is the total number of words marked.
Measured: Month 12
MacArthur-Bates Communicative Development Inventory (CDI) Score
Parent report instrument that measures early language development, including productive vocabulary. Parents mark each example of words that their child says. The total score is the total number of words marked.
Measured: Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start9 Jun 2025
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Families With InfantsStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Caitlin Canfield, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06941337
- Sponsor's protocol ID
- 24-01988
- Other IDs
- 1R01MD018597
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2025
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: caitlin.canfield@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HEALTHYSTEPS + PLAYREADVIP EFFECTS ON PARENTING AND CHILD DEVELOPMENT: A RANDOMIZED IMPLEMENTATION EFFECTIVENESS TRIAL
- ClinicalTrials.gov ID
- NCT06941337
- Acronym / sponsor ID
- 24-01988
- Conditions
- Families With Infants
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 9 Jun 2025 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 23 Apr 2025 (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 aims to investigate the effectiveness and implementation outcomes for the integration of two evidence-based practices and interventions (EBPIs) within pediatric primary care settings: HealthySteps (HS), which provides parenting support, and PlayReadVIP, which promotes relational health through video coaching. Families will be randomized to receive either the integrated HS + PlayReadVIP model or traditional HS, and investigators will examine impacts on parenting, parent-child relationships, and child development, as well as feasibility, acceptability, and appropriateness of the integrated intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HealthySteps + PlayReadVIP | Experimental | Behavioral: HealthySteps (HS), Behavioral: PlayReadVIPFamilies (parent-child dyads) randomized to receive HealthySteps (HS), which provides parenting support, plus PlayReadVIP, which promotes relational health through video coaching. |
| Standard HealthySteps | Active comparator | Behavioral: HealthySteps (HS)Families (parent-child dyads) randomized to receive HealthySteps (HS), which provides parenting support, only. |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Parent is a biological parent or legal guardian and at least 18 years of age
- Infants must be ≤6 months old at the time of enrollment.
- Parents/guardians must speak either English or Spanish to ensure they can fully engage with the intervention and assessments.
- Families must be identified as Tier 3 HealthySteps participants, indicating higher levels of need based on clinic screening for factors such as:Adverse Childhood Experiences (ACEs) and parenting challenges or vulnerabilities.
- Parent is able to willing to provide consent for their own and their child's participation.
Key exclusion criteria (5 listed)
- Non-singleton child
- Parent is unable to provide consent
- Parent does not speak English or Spanish, as study materials (e.g., questionnaires) are available in those languages
- Parent has a severe medical or psychiatric impairment (e.g., intellectual disability, psychosis) that would interfere with study participation
- Parent has plans to discontinue care at NYU Langone Health - Sunset Park Family Health Centers
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 |
|---|---|---|
| HealthySteps (HS)Evidence-based program that focuses on addressing Adverse Childhood Experiences (ACEs) and family stressors. The program provides parenting guidance, mental health support, and care coordination. The program is delivered during well-child visits by an HS specialist. | Behavioural | HealthySteps + PlayReadVIP, Standard HealthySteps |
| PlayReadVIPEvidence-based program that promotes Positive Childhood Experiences (PCEs) and strengthens parent-child interactions. The program involves recording and reviewing videos of parents engaging with their child to provide feedback and encourage positive practices. Families receive toys, books, and guides to extend activities at home. | Behavioural | HealthySteps + PlayReadVIP |
Primary outcome
Adult-Child Relationship Scale Score
Time frame: Month 12
13-item assessment of parent-child relationship quality. Each item is rated on a Likert 5 scale from 1 (definitely not) to 5 (definitely). The total score is the average of item responses and ranges from 1-5; higher scores indicate a stronger and more positive relationship between the child and parent.
Adult-Child Relationship Scale Score
Time frame: Month 24
13-item assessment of parent-child relationship quality. Each item is rated on a Likert 5 scale from 1 (definitely not) to 5 (definitely). The total score is the average of item responses and ranges from 1-5; higher scores indicate a stronger and more positive relationship between the child and parent.
Stimulation Questionnaire (StimQ) Core: Reading, Teaching, Verbal Responsivity Score
Time frame: Month 12
The StimQ is a parent-report measure of the cognitive home environment, designed to assess the level of cognitive stimulation children receive at home. Items include dichotomous (yes or no) and Likert-style responses ranging from 0-4. The total score is the sum of item responses and ranges from 0 to 43; higher scores are correlated with better parental behavior.
Stimulation Questionnaire (StimQ) Core: Reading, Teaching, Verbal Responsivity Score
Time frame: Month 24
The StimQ is a parent-report measure of the cognitive home environment, designed to assess the level of cognitive stimulation children receive at home. Items include dichotomous (yes or no) and Likert-style responses ranging from 0-4. The total score is the sum of item responses and ranges from 0 to 43; higher scores are correlated with better parental behavior.
Infant Behavior Questionnaire Score
Time frame: Month 12
36-item parent-report questionnaire used to measure the temperament of an infant (3-12 months old). Each item is rated on a scale from 1 (never) to 7 (always); the total score is the average of responses and ranges from 1-7; higher scores indicating greater frequency of behaviors.
Brief Infant Toddler Social-Emotional Assessment (BITSEA) Score: Competence
Time frame: Month 12
BITSEA measures socioemotional development in toddlerhood. 11 of the items cover competence. Each item is rated on a scale from 0-2. The total BITSEA Competence Score is the sum of responses and ranges from 0-22; higher scores indicate greater functioning.
Brief Infant Toddler Social-Emotional Assessment (BITSEA) Score: Problems
Time frame: Month 12
BITSEA measures socioemotional development in toddlerhood. 31 of the items cover problems. Each item is rated on a scale from 0-2. The total BITSEA Problems Score is the sum of responses and ranges from 0-62; higher scores indicate poorer functioning.
Child Behavior Checklist Score
Time frame: Month 24
100-item questionnaire identifying problem behavior in children. Each item is rated on a scale from 0 (absent) to 2 (often occurs). The raw score is the sum of responses and is transformed into a final t-score ranging from 0-100 with a mean of 50 and standard deviation of 10. T-scores below 60 indicate non-clinical symptoms; t-scores between 60 and 64 indicate that the child is at risk for problem behaviors; and t-scores above 65 indicate clinical symptoms.
21 secondary outcomes
Edinburgh Depression Scale (EPDS) Score
Time frame: Baseline
Edinburgh Depression Scale (EPDS) Score
Time frame: Month 12
Edinburgh Depression Scale (EPDS) Score
Time frame: Month 24
Perceived Stress Scale (PSS) Score
Time frame: Baseline
Perceived Stress Scale (PSS) Score
Time frame: Month 12
Perceived Stress Scale (PSS) Score
Time frame: Month 24
Parenting Self-Agency Measure
Time frame: Baseline
Parenting Self-Agency Measure
Time frame: Month 12
Parenting Self-Agency Measure
Time frame: Month 24
Patient-Reported Outcomes Measurement Information System (PROMIS): General Life Satisfaction Scale Score
Time frame: Baseline
PROMIS: General Life Satisfaction Scale Score
Time frame: Month 12
PROMIS: General Life Satisfaction Scale Score
Time frame: Month 24
Dyadic Adjustment Scale Score
Time frame: Baseline
Dyadic Adjustment Scale Score
Time frame: Month 12
Dyadic Adjustment Scale Score
Time frame: Month 24
Socolar Discipline Survey Score
Time frame: Month 12
Socolar Discipline Survey Score
Time frame: Month 24
Early Social Communication Scale (ESCS) Score
Time frame: Month 12
Early Social Communication Scale (ESCS) Score
Time frame: Month 24
MacArthur-Bates Communicative Development Inventory (CDI) Score
Time frame: Month 12
MacArthur-Bates Communicative Development Inventory (CDI) Score
Time frame: Month 24
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 4 May 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: caitlin.canfield@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
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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.
Janae Kuttamperoor contact
Caitlin Canfield principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HealthySteps (HS) and PlayReadVIP in people with Families With Infants, run by NYU Langone Health 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 4 May 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?
Contact Caitlin Canfield (2125622522, Caitlin.canfield@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adult-Child Relationship Scale Score (time frame: Month 12). The study lists 8 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 4 May 2026; AzTrials last refreshed its copy on 27 Oct 2026.