Parenting InterventionRISENCT06669624
Resilience Through Interventions for Successful Early Outcomes
A study testing Attachment and Biobehavioral Catch-up (ABC) and Waitlist with 4-month delay, then ABC in people with Parenting Intervention and Stress, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Purpose: The purpose of this research is to determine the effects of Attachment and Biobehavioral Catch-up (ABC), an evidence-based parenting program, on stress biomarkers in children. Participants: The study will involve approximately 150 caregiver-child dyads, with children aged between 24 and 42 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parenting Intervention, Stress, Caregiver Child Relationship
- What is being tested?
- Attachment and Biobehavioral Catch-up (ABC) and Waitlist with 4-month delay, then ABC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2024to Aug 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Parent/Caregiver Inclusion Criteria :
- Aged 18 or older
- Speaks English or Spanish
- Is the parent or legal guardian with legal custody of a child aged between 24 months and 42 months
- Is a primary caregiver/parent
- Has a home-like environment in which to participate in the intervention
Child Inclusion Criteria:
- Aged between 24 months and 42 months at enrollment
- Lives with the parent/caregiver at least 50% of the time
- Has experienced social risk factors, including low income, community or family violence, previous trauma/adversity exposure, prolonged separation from caregiver, significant difficulties in relationship with caregiver Child Exclusion Criteria
- Has a diagnosed genetic or congenital disorders, including but not limited to Down syndrome, cerebral palsy, seizure disorders, endocrine disorders (or is using steroid medications, including human growth hormone), or was born with birth defects
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, South Carolina, 27599
Natalie O'Brien, 919-966-0421, natalie_obrien@med.unc.edu
About this study
Official title: Leveraging Scientific Advances to Strengthen the Implementation, Evaluation, and Impacts of Intervention Programs for Children Experiencing Early Life Adversity
Purpose: The purpose of this research is to determine the effects of Attachment and Biobehavioral Catch-up (ABC), an evidence-based parenting program, on stress biomarkers in children.
Participants: The study will involve approximately 150 caregiver-child dyads, with children aged between 24 and 42 months. Participants will include primary caregivers fluent in English or Spanish, along with their children who have experienced social risk factors for adversity.
Procedures (Methods): Participants will be randomly assigned to either receive the ABC parenting program (10 sessions) immediately or be placed on a wait-list, receiving the program after about 4 months. The study procedures include caregivers completing online surveys, engaging in play-based observational tasks with their children, and collecting non-invasive biological samples (saliva, cheek swab, hair) from the children and saliva samples from the caregivers at 2-3 time-points.
- Conditions
- Parenting Intervention, Stress, Caregiver Child Relationship, Child Behavior Problem, Mental Health
- Being tested
- Attachment and Biobehavioral Catch-up (ABC), Waitlist with 4-month delay, then ABC
- Keywords
- Attachment and Biobehavioral CatchUp, Parenting Intervention, RISE study, Child behavior, Biomarkers
- Medical subject headings
- Psychological Well-Being, Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attachment and Biobehavioral Catch-up (ABC)Behavioural
10-session home visiting intervention designed to increase parental sensitivity and nurturance and decrease parental frightening behavior.
Waitlist with 4-month delay, then ABCOther
A 4-month waitlist period, after which they will also receive the home-based ABC program (same as Intervention group).
| Study group | Role | What they receive |
|---|---|---|
| ABC Program - no wait | Experimental | Participants immediately receive the home-based ABC, which targets parenting sensitivity and nurturance. Receives: Behavioral: Attachment and Biobehavioral Catch-up (ABC) |
| Waitlist-Control (ABC after delay) | Other | Participants will be placed on a four-month waitlist and then receive ABC in the same manner as the Experimental Group Receives: Behavioral: Attachment and Biobehavioral Catch-up (ABC); Other: Waitlist with 4-month delay, then ABC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child inflammation
Pediatric saliva samples will be assayed for cytokine concentrations.
Measured: Pre-intervention baseline
Child inflammation
Pediatric saliva samples will be assayed for cytokine concentrations.
Measured: 13-20 weeks after baseline
Child epigenetic age acceleration
Pediatric buccal swabs will be assayed for DNAm, which will be used to calculate child epigenetic age
Measured: Pre-intervention baseline
Child epigenetic age acceleration
Pediatric buccal swabs will be assayed for DNAm, which will be used to calculate child epigenetic age
Measured: 13-20 weeks after baseline
Child telomere length
DNA will be extracted from child buccal swabs to calculated T/S ratios.
Measured: Pre-intervention baseline
Child telomere length
DNA will be extracted from child buccal swabs to calculated T/S ratios.
Measured: 13-20 weeks after baseline
Child hair cortisol
Several strands of hair will be collected and assayed to obtain hair cortisol concentration
Measured: Pre-intervention baseline
Child hair cortisol
Several strands of hair will be collected and assayed to obtain hair cortisol concentration
Measured: 13-20 weeks after baseline
Child stress hormones
Child hair and saliva samples for cortisol, cortisone, DHEA, progesterone, and endocannabinoid levels to examine both cumulative and dynamic stress hormone responses.
Measured: Pre-intervention baseline
Child stress hormones
Child hair and saliva samples for cortisol, cortisone, DHEA, progesterone, and endocannabinoid levels to examine both cumulative and dynamic stress hormone responses.
Measured: 13-20 weeks after baseline
Parenting
Behavioral coding of parenting will be conducted using video recordings of tasks from the Early Regulation in Context Assessment.
Measured: Pre-intervention baseline
Parenting
Behavioral coding of parenting will be conducted using video recordings of tasks from the Early Regulation in Context Assessment.
Measured: 13-20 weeks after baseline
Child wellbeing
Caregiver reports of their child's quality of life will be obtained using the Pediatric Quality of Life (PedsQL) Inventory. Scores range from 0 to 100, with higher scores indicating better functioning.
Measured: Pre-intervention baseline
Child wellbeing
Caregiver reports of their child's quality of life will be obtained using the Pediatric Quality of Life (PedsQL) Inventory. Scores range from 0 to 100, with higher scores indicating better functioning.
Measured: 13-20 weeks after baseline
Child executive functioning
Child executive functioning will be assessed using the Minnesota Executive Function Scale™ The MEFS has been nationally normed based on the child's age and standardized scores are automatically generated using an algorithm that combines accuracy and response time (M = 100, SD = 15). Scores range from 60-140, with higher scores indicating better performance.
Measured: Pre-intervention baseline
Child executive functioning
Child executive functioning will be assessed using the Minnesota Executive Function Scale™ The MEFS has been nationally normed based on the child's age and standardized scores are automatically generated using an algorithm that combines accuracy and response time (M = 100, SD = 15). Scores range from 60-140, with higher scores indicating better performance.
Measured: 13-20 weeks after baseline
Child mental health
Child mental health will be assessed using caregiver reports through the Child Behavior Checklist preschool-aged form (1.5-5). We will use the total, internalizing, and externalizing subscales, with scores ranging from 0-200, 0-72, and 0-48, respectively. Higher scores represent worse functioning.
Measured: Pre-intervention baseline
Child mental health
Child mental health will be assessed using caregiver reports through the Child Behavior Checklist preschool-aged form (1.5-5). We will use the total, internalizing, and externalizing subscales, with scores ranging from 0-200, 0-72, and 0-48, respectively. Higher scores represent worse functioning.
Measured: 13-20 weeks after baseline
Caregiver anxiety
Caregiver anxiety symptoms will be assessed using the Generalized Anxiety Disorder 7-item (GAD-7) scale. The total score ranges from 0-21, with higher scores indicating more severe anxiety.
Measured: Pre-intervention baseline
Caregiver anxiety
Caregiver anxiety symptoms will be assessed using the Generalized Anxiety Disorder 7-item (GAD-7) scale. The total score ranges from 0-21, with higher scores indicating more severe anxiety.
Measured: 13-20 weeks after baseline
Caregiver depression
Caregiver depression symptoms will be assessed using the Patient Health Questionnaire-9 item form. Scores range from 0 to 27, with higher scores representing worse functioning.
Measured: Pre-intervention baseline
Caregiver depression
Caregiver depression symptoms will be assessed using the Patient Health Questionnaire-9 item form. Scores range from 0 to 27, with higher scores representing worse functioning.
Measured: 13-20 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start12 Nov 2024
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Parenting InterventionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT with a waitlist control group
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, The Duke Endowment
- Responsible party
- Sponsor
- Investigators
- Danielle Roubinov, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669624
- Sponsor's protocol ID
- 24-0889
- Acronym
- RISE
- Status last verified
- Jan 2026
- First submitted
- 28 Oct 2024
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results, as well as derived data supporting the results.
Publications
McEwen LM, O'Donnell KJ, McGill MG, Edgar RD, Jones MJ, MacIsaac JL, Lin DTS, Ramadori K, Morin A, Gladish N, Garg E, Unternaehrer E, Pokhvisneva I, Karnani N, Kee MZL, Klengel T, Adler NE, Barr RG, Letourneau N, Giesbrecht GF, Reynolds JN, Czamara D, Armstrong JM, Essex MJ, de Weerth C, Beijers R, Tollenaar MS, Bradley B, Jovanovic T, Ressler KJ, Steiner M, Entringer S, Wadhwa PD, Buss C, Bush NR, Binder EB, Boyce WT, Meaney MJ, Horvath S, Kobor MS. The PedBE clock accurately estimates DNA methylation age in pediatric buccal cells. Proc Natl Acad Sci U S A. 2020 Sep 22;117(38):23329-23335. doi: 10.1073/pnas.1820843116. Epub 2019 Oct 14.
PubMed 31611402Sullivan ADW, Roubinov D, Norona-Zhou AN, Bush NR. Do dyadic interventions impact biomarkers of child health? A state-of-the-science narrative review. Psychoneuroendocrinology. 2024 Apr;162:106949. doi: 10.1016/j.psyneuen.2023.106949. Epub 2023 Dec 27.
PubMed 38295654Shonkoff JP, Boyce WT, Bush NR, Gunnar MR, Hensch TK, Levitt P, Meaney MJ, Nelson CA, Slopen N, Williams DR, Silveira PP. Translating the Biology of Adversity and Resilience Into New Measures for Pediatric Practice. Pediatrics. 2022 Jun 1;149(6):e2021054493. doi: 10.1542/peds.2021-054493.
PubMed 35535547Dozier M, Peloso E, Lewis E, Laurenceau JP, Levine S. Effects of an attachment-based intervention on the cortisol production of infants and toddlers in foster care. Dev Psychopathol. 2008 Summer;20(3):845-59. doi: 10.1017/S0954579408000400.
PubMed 18606034Dozier, M., Bernard, K., Roben, C. K., Steele, H., & Steele, M. (2017). Attachment and biobehavioral catch-up. Handbook of attachment-based interventions, 27-49.
de Mendonca Filho EJ, Pokhvisneva I, Maalouf CM, Parent C, Mliner SB, Slopen N, Williams DR, Bush NR, Boyce WT, Levitt P, Nelson CA, Gunnar MR, Meaney MJ, Shonkoff JP, Silveira PP; JPB Research Network on Toxic Stress. Linking specific biological signatures to different childhood adversities: findings from the HERO project. Pediatr Res. 2023 Aug;94(2):564-574. doi: 10.1038/s41390-022-02415-y. Epub 2023 Jan 17.
PubMed 36650307
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Scientific Advances to Strengthen the Implementation, Evaluation, and Impacts of Intervention Programs for Children Experiencing Early Life Adversity
- ClinicalTrials.gov ID
- NCT06669624
- Acronym / sponsor ID
- RISE / 24-0889
- Conditions
- Parenting Intervention, Stress, Caregiver Child Relationship, Child Behavior Problem, Mental Health
- Keywords
- Attachment and Biobehavioral CatchUp, Parenting Intervention, RISE study, Child behavior, Biomarkers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- University of California, San Francisco, The Duke Endowment
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 1 Nov 2024 (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.
Purpose: The purpose of this research is to determine the effects of Attachment and Biobehavioral Catch-up (ABC), an evidence-based parenting program, on stress biomarkers in children.
Participants: The study will involve approximately 150 caregiver-child dyads, with children aged between 24 and 42 months. Participants will include primary caregivers fluent in English or Spanish, along with their children who have experienced social risk factors for adversity.
Procedures (Methods): Participants will be randomly assigned to either receive the ABC parenting program (10 sessions) immediately or be placed on a wait-list, receiving the program after about 4 months. The study procedures include caregivers completing online surveys, engaging in play-based observational tasks with their children, and collecting non-invasive biological samples (saliva, cheek swab, hair) from the children and saliva samples from the caregivers at 2-3 time-points.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- RCT with a waitlist control group
| Arm | Type | Receives |
|---|---|---|
| ABC Program - no wait | Experimental | Behavioral: Attachment and Biobehavioral Catch-up (ABC)Participants immediately receive the home-based ABC, which targets parenting sensitivity and nurturance. |
| Waitlist-Control (ABC after delay) | Other | Behavioral: Attachment and Biobehavioral Catch-up (ABC), Other: Waitlist with 4-month delay, then ABCParticipants will be placed on a four-month waitlist and then receive ABC in the same manner as the Experimental Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Attachment and Biobehavioral Catch-up (ABC)10-session home visiting intervention designed to increase parental sensitivity and nurturance and decrease parental frightening behavior. | Behavioural | ABC Program - no wait, Waitlist-Control (ABC after delay) |
| Waitlist with 4-month delay, then ABCA 4-month waitlist period, after which they will also receive the home-based ABC program (same as Intervention group). | Other | Waitlist-Control (ABC after delay) |
Primary outcome
Child inflammation
Time frame: Pre-intervention baseline
Pediatric saliva samples will be assayed for cytokine concentrations.
Child inflammation
Time frame: 13-20 weeks after baseline
Pediatric saliva samples will be assayed for cytokine concentrations.
Child epigenetic age acceleration
Time frame: Pre-intervention baseline
Pediatric buccal swabs will be assayed for DNAm, which will be used to calculate child epigenetic age
Child epigenetic age acceleration
Time frame: 13-20 weeks after baseline
Pediatric buccal swabs will be assayed for DNAm, which will be used to calculate child epigenetic age
Child telomere length
Time frame: Pre-intervention baseline
DNA will be extracted from child buccal swabs to calculated T/S ratios.
Child telomere length
Time frame: 13-20 weeks after baseline
DNA will be extracted from child buccal swabs to calculated T/S ratios.
Child hair cortisol
Time frame: Pre-intervention baseline
Several strands of hair will be collected and assayed to obtain hair cortisol concentration
Child hair cortisol
Time frame: 13-20 weeks after baseline
Several strands of hair will be collected and assayed to obtain hair cortisol concentration
Child stress hormones
Time frame: Pre-intervention baseline
Child hair and saliva samples for cortisol, cortisone, DHEA, progesterone, and endocannabinoid levels to examine both cumulative and dynamic stress hormone responses.
Child stress hormones
Time frame: 13-20 weeks after baseline
Child hair and saliva samples for cortisol, cortisone, DHEA, progesterone, and endocannabinoid levels to examine both cumulative and dynamic stress hormone responses.
Parenting
Time frame: Pre-intervention baseline
Behavioral coding of parenting will be conducted using video recordings of tasks from the Early Regulation in Context Assessment.
Parenting
Time frame: 13-20 weeks after baseline
Behavioral coding of parenting will be conducted using video recordings of tasks from the Early Regulation in Context Assessment.
Child wellbeing
Time frame: Pre-intervention baseline
Caregiver reports of their child's quality of life will be obtained using the Pediatric Quality of Life (PedsQL) Inventory. Scores range from 0 to 100, with higher scores indicating better functioning.
Child wellbeing
Time frame: 13-20 weeks after baseline
Caregiver reports of their child's quality of life will be obtained using the Pediatric Quality of Life (PedsQL) Inventory. Scores range from 0 to 100, with higher scores indicating better functioning.
Child executive functioning
Time frame: Pre-intervention baseline
Child executive functioning will be assessed using the Minnesota Executive Function Scale™ The MEFS has been nationally normed based on the child's age and standardized scores are automatically generated using an algorithm that combines accuracy and response time (M = 100, SD = 15). Scores range from 60-140, with higher scores indicating better performance.
Child executive functioning
Time frame: 13-20 weeks after baseline
Child executive functioning will be assessed using the Minnesota Executive Function Scale™ The MEFS has been nationally normed based on the child's age and standardized scores are automatically generated using an algorithm that combines accuracy and response time (M = 100, SD = 15). Scores range from 60-140, with higher scores indicating better performance.
Child mental health
Time frame: Pre-intervention baseline
Child mental health will be assessed using caregiver reports through the Child Behavior Checklist preschool-aged form (1.5-5). We will use the total, internalizing, and externalizing subscales, with scores ranging from 0-200, 0-72, and 0-48, respectively. Higher scores represent worse functioning.
Child mental health
Time frame: 13-20 weeks after baseline
Child mental health will be assessed using caregiver reports through the Child Behavior Checklist preschool-aged form (1.5-5). We will use the total, internalizing, and externalizing subscales, with scores ranging from 0-200, 0-72, and 0-48, respectively. Higher scores represent worse functioning.
Caregiver anxiety
Time frame: Pre-intervention baseline
Caregiver anxiety symptoms will be assessed using the Generalized Anxiety Disorder 7-item (GAD-7) scale. The total score ranges from 0-21, with higher scores indicating more severe anxiety.
Caregiver anxiety
Time frame: 13-20 weeks after baseline
Caregiver anxiety symptoms will be assessed using the Generalized Anxiety Disorder 7-item (GAD-7) scale. The total score ranges from 0-21, with higher scores indicating more severe anxiety.
Caregiver depression
Time frame: Pre-intervention baseline
Caregiver depression symptoms will be assessed using the Patient Health Questionnaire-9 item form. Scores range from 0 to 27, with higher scores representing worse functioning.
Caregiver depression
Time frame: 13-20 weeks after baseline
Caregiver depression symptoms will be assessed using the Patient Health Questionnaire-9 item form. Scores range from 0 to 27, with higher scores representing worse functioning.
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 2 Feb 2026.
- Background: PubMed 31611402McEwen LM, O'Donnell KJ, McGill MG, Edgar RD, Jones MJ, MacIsaac JL, Lin DTS, Ramadori K, Morin A, Gladish N, Garg E, Unternaehrer E, Pokhvisneva I, Karnani N, Kee MZL, Klengel T, Adler NE, Barr RG, Letourneau N, Giesbrecht GF, Reynolds JN, Czamara D, Armstrong JM, Essex MJ, de Weerth C, Beijers R, Tollenaar MS, Bradley B, Jovanovic T, Ressler KJ, Steiner M, Entringer S, Wadhwa PD, Buss C, Bush NR, Binder EB, Boyce WT, Meaney MJ, Horvath S, Kobor MS. The PedBE clock accurately estimates DNA methylation age in pediatric buccal cells. Proc Natl Acad Sci U S A. 2020 Sep 22;117(38):23329-23335. doi: 10.1073/pnas.1820843116. Epub 2019 Oct 14.
- Background: PubMed 38295654Sullivan ADW, Roubinov D, Norona-Zhou AN, Bush NR. Do dyadic interventions impact biomarkers of child health? A state-of-the-science narrative review. Psychoneuroendocrinology. 2024 Apr;162:106949. doi: 10.1016/j.psyneuen.2023.106949. Epub 2023 Dec 27.
- Background: PubMed 35535547Shonkoff JP, Boyce WT, Bush NR, Gunnar MR, Hensch TK, Levitt P, Meaney MJ, Nelson CA, Slopen N, Williams DR, Silveira PP. Translating the Biology of Adversity and Resilience Into New Measures for Pediatric Practice. Pediatrics. 2022 Jun 1;149(6):e2021054493. doi: 10.1542/peds.2021-054493.
- Background: PubMed 18606034Dozier M, Peloso E, Lewis E, Laurenceau JP, Levine S. Effects of an attachment-based intervention on the cortisol production of infants and toddlers in foster care. Dev Psychopathol. 2008 Summer;20(3):845-59. doi: 10.1017/S0954579408000400.
- BackgroundDozier, M., Bernard, K., Roben, C. K., Steele, H., & Steele, M. (2017). Attachment and biobehavioral catch-up. Handbook of attachment-based interventions, 27-49.
- Background: PubMed 36650307de Mendonca Filho EJ, Pokhvisneva I, Maalouf CM, Parent C, Mliner SB, Slopen N, Williams DR, Bush NR, Boyce WT, Levitt P, Nelson CA, Gunnar MR, Meaney MJ, Shonkoff JP, Silveira PP; JPB Research Network on Toxic Stress. Linking specific biological signatures to different childhood adversities: findings from the HERO project. Pediatr Res. 2023 Aug;94(2):564-574. doi: 10.1038/s41390-022-02415-y. Epub 2023 Jan 17.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results, as well as derived data supporting the results.
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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.
Danielle Roubinov, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attachment and Biobehavioral Catch-up (ABC) and Waitlist with 4-month delay, then ABC in people with Parenting Intervention and Stress, run by University of North Carolina, Chapel Hill 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?
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 2 Feb 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 Danielle Rouvinov, PhD (919-843-5898, roubinov@email.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child inflammation (time frame: Pre-intervention baseline). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06669624, which also lists 6 linked publications.
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 2 Feb 2026.