Respiratory DiseaseNCT06002685
Partners in Children's Health (CSN): A Randomized Trial of an Attachment Based Intervention
A study testing Attachment and Biobehavioral Catch-Up and Home-Based Book-of-the-Week in people with Respiratory Disease and Inflammation, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The goal of this randomized controlled trial is to evaluate the impacts of an attachment-based intervention (Attachment Biobehavioral Catch-Up (ABC) and Home Book-of-the-Week (HBOW) program on emerging health outcomes (i.e., common childhood illnesses, body mass index, and sleep) in low-income Latino children (N=260… Read more about this study
- Who is it for?
- Ages 8 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Disease, Inflammation, Insufficient Sleep
- What is being tested?
- Attachment and Biobehavioral Catch-Up and Home-Based Book-of-the-Week
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2023to Jan 2028
- 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 8 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Biological mothers
- Identify as Latina
- Speak English or Spanish
- Primiparous and multiparous
- Have a 9-month-old child enrolled in Medicaid
Who cannot join
- Children born prematurely (gestational age < 37 weeks)
- Children who have major complex medical conditions (e.g., heart or autoimmune conditions) that could interfere with participation in intervention sessions and/or research assessments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Attachment-Based Intervention on Low-Income Latino Children's Emerging Health Outcomes
The goal of this randomized controlled trial is to evaluate the impacts of an attachment-based intervention (Attachment Biobehavioral Catch-Up (ABC) and Home Book-of-the-Week (HBOW) program on emerging health outcomes (i.e., common childhood illnesses, body mass index, and sleep) in low-income Latino children (N=260; 9 months at enrollment). It is hypothesized that children randomized to ABC will have better health outcomes in comparison to the HBOW control group.
Read the detailed description
The proposed RCT will test the impacts of the Attachment Biobehavioral Catch-up (ABC) intervention program on child health outcomes. A total of 260 male and female infants will be enrolled in this study, with an age range of 8-12 months (infant) and 13 months- 23 months (toddler). This study will enroll primiparous and multiparous mothers who identify as Latina, speak English or Spanish, and have a 9-month-old child enrolled in Medicaid at the start of the study. Participants will be recruited in collaboration with the Children's Medical Practice (CMP) at Johns Hopkins Bayview Medical Center and matriculated on a rolling basis. Each participant will participate for approximately 15 months; the time required to complete the Time 1 assessment, either 10-week condition, and the two post-intervention assessments. The entire study is anticipated to be completed in 5 years. This RCT will test maternal sensitivity and child stress regulation as mediators of intervention effects. It will also examine the extent to which sociocultural factors moderate the effects of ABC. Behavioral methods and procedures will include surveys/questionnaires, audio/video recordings, individual or group behavioral observations, psychosocial or behavioral interventions, and other psychosocial or behavioral procedures. This RCT is powered to detect small-medium intervention effects (Cohen's d's= 0.35 - 0.50). These effect sizes align with previous studies, which have shown small to large effects on maternal sensitivity (d's = 0.23 - 0.77) and small to medium effects on main and moderated child behavioral stress regulation (d's= 0.15 - 0.48) and child physiological (cortisol) regulation, via maternal sensitivity (d=-0.36). For .80 power or higher and a two-tailed significance level of .05, power analyses performed using Optimal Design, Webpower, and Gpower software indicated a post-attrition sample size of N=221 will adequately detect main, mediated, and moderated effects of comparable size. Analyses will be conducted in SAS 9.4, SPSS 25.0, and Mplus 8 and will include regression and structural equation models. Missing data will be accommodated using multiple imputations and/or full information maximum likelihood (FIML) and estimators that are robust to non-normality when missing data are present (e.g., MLR). Data safety monitoring will be conducted by the Principal Investigators and the external Data Safety and Monitoring Board, who will review adverse events, enrollment numbers, procedure reports, raw data, outcomes, preliminary analyses, and other data which will be completed on an ongoing basis and reported to the IRB and a sponsor. Study findings stand to inform the nature and timing of preventive interventions to reduce health disparities that disproportionately impact Latino families and will advance understanding of early social influences that promote health development across the lifespan.
- Conditions
- Respiratory Disease, Inflammation, Insufficient Sleep, Digestive Disease, Skin Conditions, Body Mass Index
- Being tested
- Attachment and Biobehavioral Catch-Up, Home-Based Book-of-the-Week
- Medical subject headings
- Respiration Disorders, Inflammation, Sleep Deprivation, Digestive System Diseases, Skin Diseases, Infections, Hypersensitivity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attachment and Biobehavioral Catch-UpBehavioural
Also called ABC
The ABC program consists of 10 one-hour home-based sessions delivered by a trained parent coach. Each session includes the mother and her child together and addresses a specific topic. Principal intervention activities include a discussion of basic attachment principles, guided practice of new parenting behaviors, and a review of video clips from previous sessions to help reinforce parenting targets. The parent coach promotes (a) nurturance, especially in response to distress; (b) following the child's lead with delight; and (c) avoiding frightening caregiving behavior. As specified by the ABC protocol, any/all other family members will be invited to observe or participate in each ABC session Each full-time ABC parent coach will serve 8 to 10 families at a time (i.e., complete 8-10 hourly ABC visits per week).
Home-Based Book-of-the-WeekOther
Also called HBOW
The HBOW program is an active control condition developed by PI Berlin. It consists of 10 English/Spanish developmentally appropriate books hand-delivered weekly to the mothers. During each of the 10 weeks, a trained RA will visit each HBOW mother to drop off the book and to ask briefly about the mother's and child's well-being (using a standard set of questions). Thus, this condition will parallel the intervention condition in duration (number of weeks) and structure, although it will be less intensive in terms of participant contact time per visit.
| Study group | Role | What they receive |
|---|---|---|
| Attachment and Biobehavioral Catch-up (ABC) program | Experimental | The ABC program consists of 10 1 -hour home-based sessions delivered by a trained parent coach. Each session includes the mother and her child together and addresses a specific topic. Receives: Behavioral: Attachment and Biobehavioral Catch-Up |
| Home-Based Book-of-the-Week (HBOW) program | Active comparator | The HBOW program consists of 10 English/Spanish developmentally appropriate books hand-delivered weekly to the mothers. A trained RA will utilize a standard set of questions to ask about the mother's and child's well-being. Receives: Other: Home-Based Book-of-the-Week |
What is being measured
The primary outcome is the main question the study is designed to answer.
Common Childhood Illnesses (cough, runny nose, prescribed antibiotic use)
This outcome will be assessed via maternal report and review of the child's electronic health record (EHR). Using the International Classification of Primary Care, mother's responses will be coded into one of five categories reflecting the frequency of general illnesses, respiratory illnesses, digestive illnesses, skin conditions, and antibiotic use.
Measured: This data will be gathered at Time 1 (9 months).
Common Childhood Illnesses (cough, runny nose, prescribed antibiotic use)
This outcome will be assessed via maternal report and review of the child's electronic health record (EHR). Using the International Classification of Primary Care, mother's responses will be coded into one of five categories reflecting the frequency of general illnesses, respiratory illnesses, digestive illnesses, skin conditions, and antibiotic use.
Measured: This data will be gathered at Time 2 (15 months).
Common Childhood Illnesses (cough, runny nose, prescribed antibiotic use)
This outcome will be assessed via maternal report and review of the child's electronic health record (EHR). Using the International Classification of Primary Care, mother's responses will be coded into one of five categories reflecting the frequency of general illnesses, respiratory illnesses, digestive illnesses, skin conditions, and antibiotic use.
Measured: This data will be gathered at Time 3 (24 months).
Rapid Weight Gain
This outcome will be assessed through a review of the children's Electronic Health Record.
Measured: This data will be gathered at Time 1 (9 months).
Rapid Weight Gain
This outcome will be assessed through a review of the children's Electronic Health Record.
Measured: This data will be gathered at Time 2 (15 months).
Rapid Weight Gain
This outcome will be assessed through a review of the children's Electronic Health Record.
Measured: This data will be gathered at Time 3 (24 months).
Expressive Speech Delay
This outcome will be assessed through a review of the children's Electronic Health Record.
Measured: This data will be gathered at Time 1 (9 months).
Expressive Speech Delay
This outcome will be assessed through a review of the children's Electronic Health Record.
Measured: This data will be gathered at Time 2 (15 months).
Expressive Speech Delay
This outcome will be assessed through a review of the children's Electronic Health Record.
Measured: This data will be gathered at Time 3 (24 months).
Other Pediatric Health Problem(s)
This outcome will be assessed through a review of the children's Electronic Health Record.
Measured: This data will be gathered at Time 1 (9 months).
Other Pediatric Health Problem(s)
This outcome will be assessed through a review of the children's Electronic Health Record.
Measured: This data will be gathered at Time 2 (15 months).
Other Pediatric Health Problem(s)
This outcome will be assessed through a review of the children's Electronic Health Record.
Measured: This data will be gathered at Time 3 (24 months).
Low Grade Inflammation
This outcome will be assessed via markers of C-reactive protein (CRP) and interleukin-6 (IL-6) through a collection of blood spots using a traditional finger-prick. Blood spot collection is required at the 24-month pediatric well-child visit for all Baltimore City residents.
Measured: This data will be gathered at Time 3 (24 months).
Body Mass Index
This outcome will be collected by an RA by measuring the child's length and weight. Length will be measured using a measurement board. All weight measurements will be obtained in a clean diaper utilizing an infant scale (Seca 374). In addition to this, the child's EHR will be reviewed to extract length and weight data. BMI scores will be calculated using the World Health Organization sex-specific BMO-for-age growth charts per recent guidance for research on early obesity risk.
Measured: This data will be gathered at Time 1 (9 months).
Body Mass Index
This outcome will be collected by an RA by measuring the child's length and weight. Length will be measured using a measurement board. All weight measurements will be obtained in a clean diaper utilizing an infant scale (Seca 374). In addition to this, the child's EHR will be reviewed to extract length and weight data. BMI scores will be calculated using the World Health Organization sex-specific BMO-for-age growth charts per recent guidance for research on early obesity risk.
Measured: This data will be gathered at Time 2 (15 months).
Body Mass Index
This outcome will be collected through mothers reports about their children's current length and weight. In addition to this, the child's EHR will be reviewed to extract length and weight data. BMI scores will be calculated using the World Health Organization sex-specific BMO-for-age growth charts per recent guidance for research on early obesity risk.
Measured: This data will be gathered at Time 3 (24 months).
Sleep: Age 9 months
This outcome will be assessed using actigraphy and maternal report. A MotionWatch-8 actigraph will be placed on the child's ankle for continuous (24-hour) recording of body motility in 1-minute epochs. Values will be aggregated over 5 days to assess day/night sleep start times, minutes awake, and sleep efficiency. A total of 7 days of data will be collected to account for missing days that might occur. After the 7 days, an RA will pick up the watch from the mother. An RA will text the mothers a URL to a brief sleep diary for the collection of subjective reports on sleep variations.
Measured: Sleep data will be gathered at Time 1 (age 9 months).
Sleep: At 9 months
An RA will also administer a 33-item Brief Infant Sleep Questionnaire-Revised (BISQ-R) to assess general sleeping habits including bedtime routines, location(s) when the child sleeps, child mood upon wakening, and respondent (maternal) perception of the extent to which the child's sleep is problematic.
Measured: Sleep data will be gathered at Time 1 (at 9 months).
Sleep: Age 15 months
This outcome will be assessed using actigraphy and maternal report. A MotionWatch-8 actigraph will be placed on the child's ankle for continuous (24-hour) recording of body motility in 1-minute epochs. Values will be aggregated over 5 days to assess day/night sleep start times, minutes awake, and sleep efficiency. A total of 7 days of data will be collected to account for missing days that might occur. After the 7 days, an RA will pick up the watch from the mother. An RA will text the mothers a URL to a brief sleep diary for the collection of subjective reports on sleep variations.
Measured: Sleep data will be gathered at Time 2 (age 15 months).
Sleep: At 15 months
An RA will also administer a 33-item Brief Infant Sleep Questionnaire-Revised (BISQ-R) to assess general sleeping habits including bedtime routines, location(s) when the child sleeps, child mood upon wakening, and respondent (maternal) perception of the extent to which the child's sleep is problematic.
Measured: Sleep data will be gathered at Time 2 (at 15 months).
Sleep: Age 24 months
This outcome will be assessed using actigraphy and maternal report. A MotionWatch-8 actigraph will be placed on the child's ankle for continuous (24-hour) recording of body motility in 1-minute epochs. Values will be aggregated over 5 days to assess day/night sleep start times, minutes awake, and sleep efficiency. A total of 7 days of data will be collected to account for missing days that might occur. After the 7 days, an RA will pick up the watch from the mother. An RA will text the mothers a URL to a brief sleep diary for the collection of subjective reports on sleep variations.
Measured: Sleep data will be gathered at Time 3 (age 24 months).
Sleep: At 24 months
An RA will also administer a 33-item Brief Infant Sleep Questionnaire-Revised (BISQ-R) to assess general sleeping habits including bedtime routines, location(s) when the child sleeps, child mood upon wakening, and respondent (maternal) perception of the extent to which the child's sleep is problematic.
Measured: Sleep data will be gathered at Time 3 (at 24 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start9 Oct 2023
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (40)Papers the sponsor has linked to this study.
- Other trials for Respiratory DiseaseStudies 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
- A 2-group, pre-and post-test experimental design (N = 260; 130 in each group) will be employed. All eligible mother-child dyads will be randomly assigned to receive the intervention, Attachment Biobehavioral Catch- up (ABC),or the control, Home-Book-of-the- Week (HBOW). Assessments will take place in the participant's home and on the phone.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, Harvard School of Public Health (HSPH)
- Responsible party
- Principal investigator, Lisa Berlin, University of Maryland, Baltimore
- Investigators
- Lisa Berlin, PhD, Principal investigator, University of MarylandNatalie Slopen, PhD, Study chair, Harvard School of Public Health (HSPH)Cathi Propper, PhD, Study chair, Department of Psychology and Neuroscience at UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002685
- Sponsor's protocol ID
- HP-00103602
- Status last verified
- Jun 2026
- First submitted
- 6 Jun 2023
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD.
Publications
Dozier M, Bernard K. Coaching parents of vulnerable infants: The Attachment and Biobehavioral Catch-Up Approach. Guilford Press; 2019.
Berlin LJ, Martoccio TL, Jones Harden B. Improving early head start's impacts on parenting through attachment-based intervention: A randomized controlled trial. Dev Psychol. 2018 Dec;54(12):2316-2327. doi: 10.1037/dev0000592. Epub 2018 Oct 18.
PubMed 30335427Urquhart A, Clarke P. US racial/ethnic disparities in childhood asthma emergent health care use: National Health Interview Survey, 2013-2015. J Asthma. 2020 May;57(5):510-520. doi: 10.1080/02770903.2019.1590588. Epub 2019 Apr 8.
PubMed 30958048Kaar JL, Schmiege SJ, Kalkwarf HJ, Woo JG, Daniels SR, Simon SL. Longitudinal Assessment of Sleep Trajectories during Early Childhood and Their Association with Obesity. Child Obes. 2020 Apr;16(3):211-217. doi: 10.1089/chi.2019.0126. Epub 2019 Nov 21.
PubMed 31750742Berlin LJ, Martoccio TL, Bryce CI, Jones Harden B. Improving infants' stress-induced cortisol regulation through attachment-based intervention: A randomized controlled trial. Psychoneuroendocrinology. 2019 May;103:225-232. doi: 10.1016/j.psyneuen.2019.01.005. Epub 2019 Jan 4.
PubMed 30716550Cespedes EM, Rifas-Shiman SL, Redline S, Gillman MW, Pena MM, Taveras EM. Longitudinal associations of sleep curtailment with metabolic risk in mid-childhood. Obesity (Silver Spring). 2014 Dec;22(12):2586-92. doi: 10.1002/oby.20894. Epub 2014 Sep 19.
PubMed 25234485Dowd JB, Zajacova A, Aiello A. Early origins of health disparities: burden of infection, health, and socioeconomic status in U.S. children. Soc Sci Med. 2009 Feb;68(4):699-707. doi: 10.1016/j.socscimed.2008.12.010. Epub 2009 Jan 17.
PubMed 19152993Meltzer LJ, Pugliese CE. Sleep in young children with asthma and their parents. J Child Health Care. 2017 Sep;21(3):301-311. doi: 10.1177/1367493517712064. Epub 2017 Jun 5.
PubMed 29119809El-Sheikh M, Buckhalt JA, Granger DA, Erath SA, Acebo C. The association between children's sleep disruption and salivary interleukin-6. J Sleep Res. 2007 Jun;16(2):188-97. doi: 10.1111/j.1365-2869.2007.00593.x.
PubMed 17542949Hepworth AD, Berlin LJ, Salas K, Pardue-Kim M, Martoccio TL, Jones Harden B. Increasing maternal sensitivity to infant distress through attachment-based intervention: a randomized controlled trial. Attach Hum Dev. 2021 Dec;23(6):953-968. doi: 10.1080/14616734.2020.1834592. Epub 2020 Oct 27.
PubMed 33108981Worobey J, Lopez MI, Hoffman DJ. Maternal behavior and infant weight gain in the first year. J Nutr Educ Behav. 2009 May-Jun;41(3):169-75. doi: 10.1016/j.jneb.2008.06.005.
PubMed 19411050Hodges EA, Propper CB, Estrem H, Schultz MB. Feeding During Infancy: Interpersonal Behavior, Physiology, and Obesity Risk. Child Dev Perspect. 2020 Sep;14(3):185-191. doi: 10.1111/cdep.12376. Epub 2020 Jul 14.
PubMed 34707686Pachter LM, Coll CG. Racism and child health: a review of the literature and future directions. J Dev Behav Pediatr. 2009 Jun;30(3):255-63. doi: 10.1097/DBP.0b013e3181a7ed5a.
PubMed 19525720Williams DR, Lawrence JA, Davis BA. Racism and Health: Evidence and Needed Research. Annu Rev Public Health. 2019 Apr 1;40:105-125. doi: 10.1146/annurev-publhealth-040218-043750. Epub 2019 Feb 2.
PubMed 30601726Williams DR, Lawrence JA, Davis BA, Vu C. Understanding how discrimination can affect health. Health Serv Res. 2019 Dec;54 Suppl 2(Suppl 2):1374-1388. doi: 10.1111/1475-6773.13222. Epub 2019 Oct 29.
PubMed 31663121
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Attachment-Based Intervention on Low-Income Latino Children's Emerging Health Outcomes
- ClinicalTrials.gov ID
- NCT06002685
- Acronym / sponsor ID
- HP-00103602
- Conditions
- Respiratory Disease, Inflammation, Insufficient Sleep, Digestive Disease, Skin Conditions, Body Mass Index
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Johns Hopkins University, Harvard School of Public Health (HSPH)
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 21 Aug 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.
The goal of this randomized controlled trial is to evaluate the impacts of an attachment-based intervention (Attachment Biobehavioral Catch-Up (ABC) and Home Book-of-the-Week (HBOW) program on emerging health outcomes (i.e., common childhood illnesses, body mass index, and sleep) in low-income Latino children (N=260; 9 months at enrollment). It is hypothesized that children randomized to ABC will have better health outcomes in comparison to the HBOW control group.
Detailed description
The proposed RCT will test the impacts of the Attachment Biobehavioral Catch-up (ABC) intervention program on child health outcomes. A total of 260 male and female infants will be enrolled in this study, with an age range of 8-12 months (infant) and 13 months- 23 months (toddler). This study will enroll primiparous and multiparous mothers who identify as Latina, speak English or Spanish, and have a 9-month-old child enrolled in Medicaid at the start of the study. Participants will be recruited in collaboration with the Children's Medical Practice (CMP) at Johns Hopkins Bayview Medical Center and matriculated on a rolling basis. Each participant will participate for approximately 15 months; the time required to complete the Time 1 assessment, either 10-week condition, and the two post-intervention assessments. The entire study is anticipated to be completed in 5 years. This RCT will test maternal sensitivity and child stress regulation as mediators of intervention effects. It will also examine the extent to which sociocultural factors moderate the effects of ABC. Behavioral methods and procedures will include surveys/questionnaires, audio/video recordings, individual or group behavioral observations, psychosocial or behavioral interventions, and other psychosocial or behavioral procedures. This RCT is powered to detect small-medium intervention effects (Cohen's d's= 0.35 - 0.50). These effect sizes align with previous studies, which have shown small to large effects on maternal sensitivity (d's = 0.23 - 0.77) and small to medium effects on main and moderated child behavioral stress regulation (d's= 0.15 - 0.48) and child physiological (cortisol) regulation, via maternal sensitivity (d=-0.36). For .80 power or higher and a two-tailed significance level of .05, power analyses performed using Optimal Design, Webpower, and Gpower software indicated a post-attrition sample size of N=221 will adequately detect main, mediated, and moderated effects of comparable size. Analyses will be conducted in SAS 9.4, SPSS 25.0, and Mplus 8 and will include regression and structural equation models. Missing data will be accommodated using multiple imputations and/or full information maximum likelihood (FIML) and estimators that are robust to non-normality when missing data are present (e.g., MLR). Data safety monitoring will be conducted by the Principal Investigators and the external Data Safety and Monitoring Board, who will review adverse events, enrollment numbers, procedure reports, raw data, outcomes, preliminary analyses, and other data which will be completed on an ongoing basis and reported to the IRB and a sponsor. Study findings stand to inform the nature and timing of preventive interventions to reduce health disparities that disproportionately impact Latino families and will advance understanding of early social influences that promote health development across the lifespan.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A 2-group, pre-and post-test experimental design (N = 260; 130 in each group) will be employed. All eligible mother-child dyads will be randomly assigned to receive the intervention, Attachment Biobehavioral Catch- up (ABC),or the control, Home-Book-of-the- Week (HBOW). Assessments will take place in the participant's home and on the phone.
| Arm | Type | Receives |
|---|---|---|
| Attachment and Biobehavioral Catch-up (ABC) program | Experimental | Behavioral: Attachment and Biobehavioral Catch-UpThe ABC program consists of 10 1 -hour home-based sessions delivered by a trained parent coach. Each session includes the mother and her child together and addresses a specific topic. |
| Home-Based Book-of-the-Week (HBOW) program | Active comparator | Other: Home-Based Book-of-the-WeekThe HBOW program consists of 10 English/Spanish developmentally appropriate books hand-delivered weekly to the mothers. A trained RA will utilize a standard set of questions to ask about the mother's and child's well-being. |
Who may qualify
- Ages
- 8 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Biological mothers
- Identify as Latina
- Speak English or Spanish
- Primiparous and multiparous
- Have a 9-month-old child enrolled in Medicaid
Key exclusion criteria (2 listed)
- Children born prematurely (gestational age < 37 weeks)
- Children who have major complex medical conditions (e.g., heart or autoimmune conditions) that could interfere with participation in intervention sessions and/or research assessments.
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-UpAlso: ABCThe ABC program consists of 10 one-hour home-based sessions delivered by a trained parent coach. Each session includes the mother and her child together and addresses a specific topic. Principal intervention activities include a discussion of basic attachment principles, guided practice of new parenting behaviors, and a review of video clips from previous sessions to help reinforce parenting targets. The parent coach promotes (a) nurturance, especially in response to distress; (b) following the child's lead with delight; and (c) avoiding frightening caregiving behavior. As specified by the ABC protocol, any/all other family members will be invited to observe or participate in each ABC session Each full-time ABC parent coach will serve 8 to 10 families at a time (i.e., complete 8-10 hourly ABC visits per week). | Behavioural | Attachment and Biobehavioral Catch-up (ABC) program |
| Home-Based Book-of-the-WeekAlso: HBOWThe HBOW program is an active control condition developed by PI Berlin. It consists of 10 English/Spanish developmentally appropriate books hand-delivered weekly to the mothers. During each of the 10 weeks, a trained RA will visit each HBOW mother to drop off the book and to ask briefly about the mother's and child's well-being (using a standard set of questions). Thus, this condition will parallel the intervention condition in duration (number of weeks) and structure, although it will be less intensive in terms of participant contact time per visit. | Other | Home-Based Book-of-the-Week (HBOW) program |
Primary outcome
Common Childhood Illnesses (cough, runny nose, prescribed antibiotic use)
Time frame: This data will be gathered at Time 1 (9 months).
This outcome will be assessed via maternal report and review of the child's electronic health record (EHR). Using the International Classification of Primary Care, mother's responses will be coded into one of five categories reflecting the frequency of general illnesses, respiratory illnesses, digestive illnesses, skin conditions, and antibiotic use.
Common Childhood Illnesses (cough, runny nose, prescribed antibiotic use)
Time frame: This data will be gathered at Time 2 (15 months).
This outcome will be assessed via maternal report and review of the child's electronic health record (EHR). Using the International Classification of Primary Care, mother's responses will be coded into one of five categories reflecting the frequency of general illnesses, respiratory illnesses, digestive illnesses, skin conditions, and antibiotic use.
Common Childhood Illnesses (cough, runny nose, prescribed antibiotic use)
Time frame: This data will be gathered at Time 3 (24 months).
This outcome will be assessed via maternal report and review of the child's electronic health record (EHR). Using the International Classification of Primary Care, mother's responses will be coded into one of five categories reflecting the frequency of general illnesses, respiratory illnesses, digestive illnesses, skin conditions, and antibiotic use.
Rapid Weight Gain
Time frame: This data will be gathered at Time 1 (9 months).
This outcome will be assessed through a review of the children's Electronic Health Record.
Rapid Weight Gain
Time frame: This data will be gathered at Time 2 (15 months).
This outcome will be assessed through a review of the children's Electronic Health Record.
Rapid Weight Gain
Time frame: This data will be gathered at Time 3 (24 months).
This outcome will be assessed through a review of the children's Electronic Health Record.
Expressive Speech Delay
Time frame: This data will be gathered at Time 1 (9 months).
This outcome will be assessed through a review of the children's Electronic Health Record.
Expressive Speech Delay
Time frame: This data will be gathered at Time 2 (15 months).
This outcome will be assessed through a review of the children's Electronic Health Record.
Expressive Speech Delay
Time frame: This data will be gathered at Time 3 (24 months).
This outcome will be assessed through a review of the children's Electronic Health Record.
Other Pediatric Health Problem(s)
Time frame: This data will be gathered at Time 1 (9 months).
This outcome will be assessed through a review of the children's Electronic Health Record.
Other Pediatric Health Problem(s)
Time frame: This data will be gathered at Time 2 (15 months).
This outcome will be assessed through a review of the children's Electronic Health Record.
Other Pediatric Health Problem(s)
Time frame: This data will be gathered at Time 3 (24 months).
This outcome will be assessed through a review of the children's Electronic Health Record.
Low Grade Inflammation
Time frame: This data will be gathered at Time 3 (24 months).
This outcome will be assessed via markers of C-reactive protein (CRP) and interleukin-6 (IL-6) through a collection of blood spots using a traditional finger-prick. Blood spot collection is required at the 24-month pediatric well-child visit for all Baltimore City residents.
Body Mass Index
Time frame: This data will be gathered at Time 1 (9 months).
This outcome will be collected by an RA by measuring the child's length and weight. Length will be measured using a measurement board. All weight measurements will be obtained in a clean diaper utilizing an infant scale (Seca 374). In addition to this, the child's EHR will be reviewed to extract length and weight data. BMI scores will be calculated using the World Health Organization sex-specific BMO-for-age growth charts per recent guidance for research on early obesity risk.
Body Mass Index
Time frame: This data will be gathered at Time 2 (15 months).
This outcome will be collected by an RA by measuring the child's length and weight. Length will be measured using a measurement board. All weight measurements will be obtained in a clean diaper utilizing an infant scale (Seca 374). In addition to this, the child's EHR will be reviewed to extract length and weight data. BMI scores will be calculated using the World Health Organization sex-specific BMO-for-age growth charts per recent guidance for research on early obesity risk.
Body Mass Index
Time frame: This data will be gathered at Time 3 (24 months).
This outcome will be collected through mothers reports about their children's current length and weight. In addition to this, the child's EHR will be reviewed to extract length and weight data. BMI scores will be calculated using the World Health Organization sex-specific BMO-for-age growth charts per recent guidance for research on early obesity risk.
Sleep: Age 9 months
Time frame: Sleep data will be gathered at Time 1 (age 9 months).
This outcome will be assessed using actigraphy and maternal report. A MotionWatch-8 actigraph will be placed on the child's ankle for continuous (24-hour) recording of body motility in 1-minute epochs. Values will be aggregated over 5 days to assess day/night sleep start times, minutes awake, and sleep efficiency. A total of 7 days of data will be collected to account for missing days that might occur. After the 7 days, an RA will pick up the watch from the mother. An RA will text the mothers a URL to a brief sleep diary for the collection of subjective reports on sleep variations.
Sleep: At 9 months
Time frame: Sleep data will be gathered at Time 1 (at 9 months).
An RA will also administer a 33-item Brief Infant Sleep Questionnaire-Revised (BISQ-R) to assess general sleeping habits including bedtime routines, location(s) when the child sleeps, child mood upon wakening, and respondent (maternal) perception of the extent to which the child's sleep is problematic.
Sleep: Age 15 months
Time frame: Sleep data will be gathered at Time 2 (age 15 months).
This outcome will be assessed using actigraphy and maternal report. A MotionWatch-8 actigraph will be placed on the child's ankle for continuous (24-hour) recording of body motility in 1-minute epochs. Values will be aggregated over 5 days to assess day/night sleep start times, minutes awake, and sleep efficiency. A total of 7 days of data will be collected to account for missing days that might occur. After the 7 days, an RA will pick up the watch from the mother. An RA will text the mothers a URL to a brief sleep diary for the collection of subjective reports on sleep variations.
Sleep: At 15 months
Time frame: Sleep data will be gathered at Time 2 (at 15 months).
An RA will also administer a 33-item Brief Infant Sleep Questionnaire-Revised (BISQ-R) to assess general sleeping habits including bedtime routines, location(s) when the child sleeps, child mood upon wakening, and respondent (maternal) perception of the extent to which the child's sleep is problematic.
Sleep: Age 24 months
Time frame: Sleep data will be gathered at Time 3 (age 24 months).
This outcome will be assessed using actigraphy and maternal report. A MotionWatch-8 actigraph will be placed on the child's ankle for continuous (24-hour) recording of body motility in 1-minute epochs. Values will be aggregated over 5 days to assess day/night sleep start times, minutes awake, and sleep efficiency. A total of 7 days of data will be collected to account for missing days that might occur. After the 7 days, an RA will pick up the watch from the mother. An RA will text the mothers a URL to a brief sleep diary for the collection of subjective reports on sleep variations.
Sleep: At 24 months
Time frame: Sleep data will be gathered at Time 3 (at 24 months).
An RA will also administer a 33-item Brief Infant Sleep Questionnaire-Revised (BISQ-R) to assess general sleeping habits including bedtime routines, location(s) when the child sleeps, child mood upon wakening, and respondent (maternal) perception of the extent to which the child's sleep is problematic.
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 23 Jun 2026.
- BackgroundDozier M, Bernard K. Coaching parents of vulnerable infants: The Attachment and Biobehavioral Catch-Up Approach. Guilford Press; 2019.
- Background: PubMed 30335427Berlin LJ, Martoccio TL, Jones Harden B. Improving early head start's impacts on parenting through attachment-based intervention: A randomized controlled trial. Dev Psychol. 2018 Dec;54(12):2316-2327. doi: 10.1037/dev0000592. Epub 2018 Oct 18.
- Background: PubMed 30958048Urquhart A, Clarke P. US racial/ethnic disparities in childhood asthma emergent health care use: National Health Interview Survey, 2013-2015. J Asthma. 2020 May;57(5):510-520. doi: 10.1080/02770903.2019.1590588. Epub 2019 Apr 8.
- Background: PubMed 31750742Kaar JL, Schmiege SJ, Kalkwarf HJ, Woo JG, Daniels SR, Simon SL. Longitudinal Assessment of Sleep Trajectories during Early Childhood and Their Association with Obesity. Child Obes. 2020 Apr;16(3):211-217. doi: 10.1089/chi.2019.0126. Epub 2019 Nov 21.
- Background: PubMed 30716550Berlin LJ, Martoccio TL, Bryce CI, Jones Harden B. Improving infants' stress-induced cortisol regulation through attachment-based intervention: A randomized controlled trial. Psychoneuroendocrinology. 2019 May;103:225-232. doi: 10.1016/j.psyneuen.2019.01.005. Epub 2019 Jan 4.
- Background: PubMed 25234485Cespedes EM, Rifas-Shiman SL, Redline S, Gillman MW, Pena MM, Taveras EM. Longitudinal associations of sleep curtailment with metabolic risk in mid-childhood. Obesity (Silver Spring). 2014 Dec;22(12):2586-92. doi: 10.1002/oby.20894. Epub 2014 Sep 19.
- Background: PubMed 19152993Dowd JB, Zajacova A, Aiello A. Early origins of health disparities: burden of infection, health, and socioeconomic status in U.S. children. Soc Sci Med. 2009 Feb;68(4):699-707. doi: 10.1016/j.socscimed.2008.12.010. Epub 2009 Jan 17.
- Background: PubMed 29119809Meltzer LJ, Pugliese CE. Sleep in young children with asthma and their parents. J Child Health Care. 2017 Sep;21(3):301-311. doi: 10.1177/1367493517712064. Epub 2017 Jun 5.
- Background: PubMed 17542949El-Sheikh M, Buckhalt JA, Granger DA, Erath SA, Acebo C. The association between children's sleep disruption and salivary interleukin-6. J Sleep Res. 2007 Jun;16(2):188-97. doi: 10.1111/j.1365-2869.2007.00593.x.
- Background: PubMed 33108981Hepworth AD, Berlin LJ, Salas K, Pardue-Kim M, Martoccio TL, Jones Harden B. Increasing maternal sensitivity to infant distress through attachment-based intervention: a randomized controlled trial. Attach Hum Dev. 2021 Dec;23(6):953-968. doi: 10.1080/14616734.2020.1834592. Epub 2020 Oct 27.
- Background: PubMed 19411050Worobey J, Lopez MI, Hoffman DJ. Maternal behavior and infant weight gain in the first year. J Nutr Educ Behav. 2009 May-Jun;41(3):169-75. doi: 10.1016/j.jneb.2008.06.005.
- Background: PubMed 34707686Hodges EA, Propper CB, Estrem H, Schultz MB. Feeding During Infancy: Interpersonal Behavior, Physiology, and Obesity Risk. Child Dev Perspect. 2020 Sep;14(3):185-191. doi: 10.1111/cdep.12376. Epub 2020 Jul 14.
- Individual participant dataSharing planned: Yes. All collected IPD.
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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.
Lisa Berlin, PhD principal investigator
University of Maryland
Natalie Slopen, PhD study chair
Harvard School of Public Health (HSPH)
Cathi Propper, PhD study chair
Department of Psychology and Neuroscience at UNC 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 and Home-Based Book-of-the-Week in people with Respiratory Disease and Inflammation, run by University of Maryland, Baltimore 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 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 23 Jun 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?
Common Childhood Illnesses (cough, runny nose, prescribed antibiotic use) (time frame: This data will be gathered at Time 1 (9 months).). 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 NCT06002685, which also lists 40 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 23 Jun 2026.