Opioid Use DisorderCHAMPSNCT05488379
Child Healthcare at MATER - Pediatric Study
A study testing Group well child care in people with Opioid Use Disorder, run by Thomas Jefferson University at 1 site in United States.
Trial summary
The objective of this project is to implement and evaluate a group model of well child care for mothers in treatment for opioid use disorder and their children that addresses the specific health needs and concerns of opioid-exposed infants, is trauma informed, and is embedded within a maternal opioid use disorder… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Group well child care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2021to 29 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 28 weeks pregnant or less than 2 weeks postpartum
- receiving treatment for opioid use disorder
- ability to read and speak English
- plans to parent infant after delivery
- intent to seek pediatric care within Nemours/Thomas Jefferson University system
- intent to remain in the Philadelphia area for the next 2 years
Who cannot join
- inability to speak English
- plans to move outside of the Philadelphia area in the next 2 years
- plans to not parent infant after delivery
- plans to seek pediatric care outside of the Nemours/Thomas Jefferson University System
- Following a live birth, participants will remain eligible to continue in the study unless the mother or infant experiences the following: gestational age at time of delivery less than or equal to 32 weeks or illness or clinical complication warranting prolonged hospitalization after delivery.
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19106
About this study
Official title: Well Child Care Intervention for Infants of Mothers in Treatment for Opioid Use Disorder
The objective of this project is to implement and evaluate a group model of well child care for mothers in treatment for opioid use disorder and their children that addresses the specific health needs and concerns of opioid-exposed infants, is trauma informed, and is embedded within a maternal opioid use disorder treatment program. 108 mother-infant dyads will be randomized 1:1 to group well child care or individual well child care, and followed over an 18 month period. Qualitative and quantitative data will be collected at multiple time points. The efficacy of group well child care to improve health and healthcare-related outcomes will be evaluated.
Read the detailed description
This is a single-site cluster randomized controlled trial. Over an 18-month period, 108 pregnant women receiving treatment for opioid use disorder will be identified, screened, and enrolled into the study. Beginning with the birthdate of the first infant born in the study, 18 consecutive 1-month birth intervals will be randomized in a 1:1 ratio to one of two study arms: (1) group well child care or (2) individual well child care. Nine birth clusters will be randomized to individual well child care(control arm) and nine birth clusters will be randomized to group well child care(intervention arm), with concealment of randomization from enrolled participants until they give birth. All study participants will be included in the study until their child is approximately 18 months of age. All study participants will have a total of 5 assessment visits with research personnel; visits will occur immediately following enrollment into the study (baseline), prior to the participant's child turning 1 month of age, and within 4 weeks of the participant's child turning 6, 12, and 18 months of age. The efficacy of group well child care to improve health and healthcare-related outcomes will be evaluated.
- Conditions
- Opioid Use Disorder
- Being tested
- Group well child care
- Keywords
- Group well child care, Child developement, Parenting behavior, Healthcare quality, Healthcare experience
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group well child careOther
Also called CenteringParenting
Beginning with the 1-month well child care visit, mother-infant dyads will participate in well child care together, with subsequent visits occurring at the American Academy of Pediatrics recommended intervals (2, 4, 6, 9, 12, 15, and 18 months of age).
| Study group | Role | What they receive |
|---|---|---|
| Individual well child care | No intervention | Individuals randomized to the control arm will receive routine individualized well child care after birth hospital discharge. |
| Group well child care | Experimental | Individuals randomized to the intervention arm will participate in group well child care after birth hospital discharge. Receives: Other: Group well child care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Well child care engagement
Measured as both utilization and experience of well child care. Utilization will be defined as total number of well child care visits during the child's first 18 months of life. Adequacy of well child care during this time period will be dichotomized as adequate (7 well child care visits) or inadequate (<7 well child care visits). This definition is adapted from the Health Plan Employer Data and Information Set (HEDIS) measure for well child care. The Promoting Healthy Development Survey (PHDS) will be used to evaluate participants' perceptions of their child's well child care, including anticipatory guidance, developmental surveillance, family-centeredness, family risk assessment, and helpfulness of care.
Measured: 18 months post-delivery
Parenting Knowledge
A survey instrument will include investigator-developed questions as well as questions from the Knowledge of Infant Development Inventory (KIDI).
Measured: 18 months post-delivery
Maternal-child interaction quality
This will be directly assessed using a video recorded mother/child free play at 18 months. Interactions will be coded by using the Keys to Interactive Parenting Scale (KIPS). KIPS is a structured observational measure and assesses 12 domains of parenting. The domains are scored on a 1 to 5-point scale with higher scores indicating higher quality parenting behaviors.
Measured: 18 months post-delivery
Secondary outcomes (12)
Infant healthcare utilization
lead screening; up-to-date immunization status based on the CDC immunization schedule; maternal depression screening; PEDS developmental screening; infant Hepatitis C screening among those with perinatal Hepatitis C exposure; number of acute primary care visits (sick visits); emergency department utilization and hospitalization; subspecialist referrals and visits; early intervention referral and enrollment.
Measured: 18 months of age
Infant development
self reported using Ages \& Stages Questionnaires, 3rd Edition (ASQ-3), a set of 40-item parent-reported age-specific development screening questions assessing communication, gross motor, fine motor, problem solving and personal-social skills. Scores for each of the five domains range from 0-60 with higher scores indicating typical development.
Measured: 6 months of age
Infant development
self reported using Ages \& Stages Questionnaires, 3rd Edition (ASQ-3), a set of 40-item parent-reported age-specific development screening questions assessing communication, gross motor, fine motor, problem solving and personal-social skills. Scores for each of the five domains range from 0-60 with higher scores indicating typical development.
Measured: 12 months of age
Infant development
self reported using Ages \& Stages Questionnaires, 3rd Edition (ASQ-3), a set of 40-item parent-reported age-specific development screening questions assessing communication, gross motor, fine motor, problem solving and personal-social skills. Scores for each of the five domains range from 0-60 with higher scores indicating typical development.
Measured: 18 months of age
Maternal health behaviors
self-reported duration of breastfeeding, infant sleep positioning, contraception use , and repeat pregnancy.
Measured: 12 months of age
Maternal psychosocial
depression using the Edinburgh Postnatal Depression Scale
The EPDS is a 10-item self report used to measure postpartum depression. Scores range from 0-30, with a higher score indicating a greater severity of depression.
Measured: 18 months of age
Maternal psychosocial
General stress using the Perceived Stress Scale (PSS; higher scores indicate higher stress)
The Perceived Stress Scale (PSS) is a 10-item scale to measure stress. Scores range from 0-40, with higher scores indicating greater perceived stress.
Measured: 18 months of age
Maternal psychosocial
Parenting stress using the Parenting Stress Index (PSI)
The Parenting Stress Index (PSI) is a 36-item questionnaire assessing parental stress. Total scores range from 36 to 180, with higher scores indicating greater parental stress.
Measured: 18 months of age
Maternal psychosocial
Social support using the Social Provisions Scale (SPS)
The Social Provisions Scale (SPS) is one of the most frequently used scales on social support, and is validated to measure the components of social support that directly impact health outcomes: attachment, social integration, reassurance of worth, reliable alliance, guidance, and opportunity for nurturance.
Measured: 18 months of age
Maternal return to illicit substance abuse
Any number of positive urine drug screens for illicit substance(s)
Measured: 18 months of age
Maternal sensitivity/responsiveness
Self-reported using the Maternal Responsiveness Questionnaire, which measures the extent to which mothers respond promptly to their infants across different situations. The measure yields 3 subscales: responsiveness, non-responsiveness, and delayed responsiveness. Higher scores indicate higher tendency for responsiveness, non-responsiveness, and delayed responsiveness.
Measured: 12 months of age
Maternal sensitivity/responsiveness
Self-reported using the Coping with Toddlers' Negative Emotions Scale (CTNES) which measures the degree to which mother perceive themselves as reactive to their children's negative affect in distressful situations.
The CTNES consists of scenarios in which youth may experience negative emotion. Parents are asked to identify how they would respond to each scenario. Each scenario has six responses which parents rate on a 7 point Likert-scale regarding their likelihood of responding that way (1 = very unlikely, 7 = very likely). This measure has six subscales which include emotion focused, problem-focused, minimization, punitive, expressive encouragement, and distress responses. Higher scores indicate a higher presence of that parenting response.
Measured: 18 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start31 Dec 2021
- Primary completion29 Jan 2026
- Study completion29 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Alfred I. duPont Hospital for Children
- Responsible party
- Sponsor
- Investigators
- Vanessa Short, PhD, Principal investigator, Thomas Jefferson UniversityNeera Goyal, MD, Principal investigator, Nemours Al DuPont Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488379
- Sponsor's protocol ID
- 17540
- Acronym
- CHAMPS
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2022
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Short VL, Abatemarco DJ, Sood E, Hand DJ, Gannon M, Hossain J, Goyal NK. The Child Healthcare at MATER Pediatric Study (CHAMPS): a 2-arm cluster randomized control trial of group well child care for mothers in treatment for opioid use disorder and their children. Trials. 2023 May 17;24(1):333. doi: 10.1186/s13063-023-07357-2.
PubMed 37194074
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Well Child Care Intervention for Infants of Mothers in Treatment for Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT05488379
- Acronym / sponsor ID
- CHAMPS / 17540
- Conditions
- Opioid Use Disorder
- Keywords
- Group well child care, Child developement, Parenting behavior, Healthcare quality, Healthcare experience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Alfred I. duPont Hospital for Children
- Study start
- 31 Dec 2021 (actual)
- Primary completion
- 29 Jan 2026 (actual)
- Study completion
- 29 Jan 2026 (actual)
- First posted
- 4 Aug 2022 (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 objective of this project is to implement and evaluate a group model of well child care for mothers in treatment for opioid use disorder and their children that addresses the specific health needs and concerns of opioid-exposed infants, is trauma informed, and is embedded within a maternal opioid use disorder treatment program. 108 mother-infant dyads will be randomized 1:1 to group well child care or individual well child care, and followed over an 18 month period. Qualitative and quantitative data will be collected at multiple time points. The efficacy of group well child care to improve health and healthcare-related outcomes will be evaluated.
Detailed description
This is a single-site cluster randomized controlled trial. Over an 18-month period, 108 pregnant women receiving treatment for opioid use disorder will be identified, screened, and enrolled into the study. Beginning with the birthdate of the first infant born in the study, 18 consecutive 1-month birth intervals will be randomized in a 1:1 ratio to one of two study arms: (1) group well child care or (2) individual well child care. Nine birth clusters will be randomized to individual well child care(control arm) and nine birth clusters will be randomized to group well child care(intervention arm), with concealment of randomization from enrolled participants until they give birth. All study participants will be included in the study until their child is approximately 18 months of age. All study participants will have a total of 5 assessment visits with research personnel; visits will occur immediately following enrollment into the study (baseline), prior to the participant's child turning 1 month of age, and within 4 weeks of the participant's child turning 6, 12, and 18 months of age. The efficacy of group well child care to improve health and healthcare-related outcomes will be evaluated.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individual well child care | No intervention | –Individuals randomized to the control arm will receive routine individualized well child care after birth hospital discharge. |
| Group well child care | Experimental | Other: Group well child careIndividuals randomized to the intervention arm will participate in group well child care after birth hospital discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- at least 28 weeks pregnant or less than 2 weeks postpartum
- receiving treatment for opioid use disorder
- ability to read and speak English
- plans to parent infant after delivery
- intent to seek pediatric care within Nemours/Thomas Jefferson University system
Key exclusion criteria (5 listed)
- inability to speak English
- plans to move outside of the Philadelphia area in the next 2 years
- plans to not parent infant after delivery
- plans to seek pediatric care outside of the Nemours/Thomas Jefferson University System
- Following a live birth, participants will remain eligible to continue in the study unless the mother or infant experiences the following: gestational age at time of delivery less than or equal to 32 weeks or illness or clinical complication warranting prolonged hospitalization after delivery.
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 |
|---|---|---|
| Group well child careAlso: CenteringParentingBeginning with the 1-month well child care visit, mother-infant dyads will participate in well child care together, with subsequent visits occurring at the American Academy of Pediatrics recommended intervals (2, 4, 6, 9, 12, 15, and 18 months of age). | Other | Group well child care |
Primary outcome
Well child care engagement
Time frame: 18 months post-delivery
Measured as both utilization and experience of well child care. Utilization will be defined as total number of well child care visits during the child's first 18 months of life. Adequacy of well child care during this time period will be dichotomized as adequate (7 well child care visits) or inadequate (<7 well child care visits). This definition is adapted from the Health Plan Employer Data and Information Set (HEDIS) measure for well child care. The Promoting Healthy Development Survey (PHDS) will be used to evaluate participants' perceptions of their child's well child care, including anticipatory guidance, developmental surveillance, family-centeredness, family risk assessment, and helpfulness of care.
Parenting Knowledge
Time frame: 18 months post-delivery
A survey instrument will include investigator-developed questions as well as questions from the Knowledge of Infant Development Inventory (KIDI).
Maternal-child interaction quality
Time frame: 18 months post-delivery
This will be directly assessed using a video recorded mother/child free play at 18 months. Interactions will be coded by using the Keys to Interactive Parenting Scale (KIPS). KIPS is a structured observational measure and assesses 12 domains of parenting. The domains are scored on a 1 to 5-point scale with higher scores indicating higher quality parenting behaviors.
12 secondary outcomes
Infant healthcare utilization
Time frame: 18 months of age
Infant development
Time frame: 6 months of age
Infant development
Time frame: 12 months of age
Infant development
Time frame: 18 months of age
Maternal health behaviors
Time frame: 12 months of age
Maternal psychosocial
Time frame: 18 months of age
Maternal psychosocial
Time frame: 18 months of age
Maternal psychosocial
Time frame: 18 months of age
Maternal psychosocial
Time frame: 18 months of age
Maternal return to illicit substance abuse
Time frame: 18 months of age
Maternal sensitivity/responsiveness
Time frame: 12 months of age
Maternal sensitivity/responsiveness
Time frame: 18 months of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Derived from this study: PubMed 37194074Short VL, Abatemarco DJ, Sood E, Hand DJ, Gannon M, Hossain J, Goyal NK. The Child Healthcare at MATER Pediatric Study (CHAMPS): a 2-arm cluster randomized control trial of group well child care for mothers in treatment for opioid use disorder and their children. Trials. 2023 May 17;24(1):333. doi: 10.1186/s13063-023-07357-2.
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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.
Vanessa Short, PhD principal investigator
Thomas Jefferson University
Neera Goyal, MD principal investigator
Nemours Al DuPont Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group well child care in people with Opioid Use Disorder, run by Thomas Jefferson University 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 6 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: finished, as of the sponsor's last update on 23 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Well child care engagement (time frame: 18 months post-delivery). The study lists 3 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 NCT05488379, which also lists 1 linked publication.
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 Apr 2026.