Developmental DelayINTACTNCT06423664
Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure
A study testing Play and Learn Strategies (PALS) Program in people with Developmental Delay, run by IDeA States Pediatric Clinical Trials Network at 3 sites in United States.
Trial summary
The INTACT trial is a multisite pilot feasibility study aimed at testing the effectiveness of the INTACT Intervention program in improving neurodevelopmental outcomes in infants prenatally exposed to cannabinoids. Read more about this study
- Who is it for?
- Ages Up to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Developmental Delay
- What is being tested?
- Play and Learn Strategies (PALS) Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- 6 Feb 2025to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Birthing Parent
- Age of majority, as defined by the state of residency
- Cannabinoid use during pregnancy confirmed with self-report
- Have the ability to speak, read, and understand English
- Birthing parent who delivered at one of the hospitals where study team members have clinical privileges to access medical records
- Has parental custody of the infant
Show all 12Show fewer
- Singleton pregnancy with live birth
- Has an electronic device capable of watching videos and able to stream/download videos for viewing and permitting video conferencing
- Has study access to the internet
- Infant
- Term infants at birth (>37 weeks' gestation)
- Biological child of the birthing parent
Who cannot join
- Birthing Parent
- Other illicit drug use, excluding cannabinoids, during pregnancy (such as heroin or cocaine) per self-reported or toxicology results
- Opiate use (prescribed or unprescribed) per self-report or toxicology results during this pregnancy
- Prolonged hospitalization following delivery longer than 7 days
- Infant
- Has major birth defect(s) including physical anomalies including limb malformations/absence of limbs or chromosomal abnormalities
- Diagnosed with neonatal encephalopathy, metabolic disorder, stroke, intracranial hemorrhage, or meningitis during birth hospitalization
- Received any major surgical intervention during the birth hospitalization or required a prolonged birth hospitalization (prolonged hospitalization being any hospitalization longer than 7 days)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131
Jessie Maxwell, MD, JRMaxwell@salud.unm.edu
Sandra Beauman, MSN, SBeauman@salud.unm.edu
- Recruiting
University of Vermont Medical Center
Burlington, Vermont, 05401
Leigh-Anne Cioffredi, MD, Leigh-Anne.Cioffredi@uvmhealth.org
Laurie Chassereau, RN, laurie.chassereau@med.uvm.edu
- Recruiting
Avera Research Institute
Sioux Falls, South Dakota, 57108
Maria Barber, DO, Maria.Barber@avera.org
Meggie McCoy, BS, (605) 504-3154, Meggie.McCoy@avera.org
About this study
Official title: Pilot Feasibility Trial of Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure (INTACT)
The INTACT trial is a multisite pilot feasibility study aimed at testing the effectiveness of the INTACT Intervention program in improving neurodevelopmental outcomes in infants prenatally exposed to cannabinoids. The trial will enroll 20 birthing parent/infant dyads across three sites and will evaluate feasibility endpoints rather than clinical outcomes. The study duration is 22 months, including study start-up, enrollment and intervention, and data analysis and manuscript preparation.
Read the detailed description
The INTACT trial is designed to address the need for interventions to improve neurodevelopmental outcomes in infants exposed to cannabinoids in utero. It is a multi-site pilot study conducted across three Institutional Development Award (IDeA) States Pediatric Clinical Trials Network (ISPCTN) sites. The trial aims to evaluate the feasibility of the INTACT Intervention program, which focuses on training birthing parents in contingent responding to promote early language, cognitive, and social development in their infants.
The study intervention consists of 12 monthly INTACT intervention coaching sessions, each comprising online module completion followed by personalized coaching sessions with interventionists certified to deliver the Play and Learn Strategies (PALS) methodology, which forms the basis for the INTACT intervention. The online modules focus on strengthening effective parenting practices, while the coaching sessions guide birthing parents in contingent responding techniques, such as reading infant signals and responding with warm and sensitive behaviors. There are three objectives for this study, examining 1) Participant Recruitment, 2) Participant Completion, and 3) Participant Adherence.
Objective 1 examines if birthing parents can be recruited and enrolled in the study. The endpoint of this objective is the percentage of potential participants approached for the study that are consented and determined to be eligible for study participation.
Objective 2 evaluates participant completion, as measured by the percent of birthing parent/infant dyads that complete the coaching session scheduled when the child is 12 months of age.
Objective 3 evaluates the number of individual INTACT intervention coaching sessions completed.
The study duration is planned for 22 months, including 1-4 months for study development and start-up, 3 months for enrollment, 12 months for the intervention, and 3 months for data organization, clean-up, and manuscript preparation.
The INTACT trial will not assess clinical outcomes but will inform the design of a future larger-scale clinical trial to evaluate the effectiveness of the INTACT Intervention program in improving neurodevelopmental outcomes in infants prenatally exposed to cannabinoids.
- Conditions
- Developmental Delay
- Being tested
- Play and Learn Strategies (PALS) Program
- Keywords
- Behavioral health intervention, Prenatal substance exposure, Neurodevelopmental outcomes, Pediatric intervention, Developmental disorders, Pediatric health
- Medical subject headings
- Learning Disabilities, Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Play and Learn Strategies (PALS) ProgramBehavioural
Also called ePALS
Monthly modules and personalized coaching sessions designed to strengthen maternal responsiveness and sensitivity which, in turn, improves infant social-emotional behavior and development outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Personalized coaching sessions | Experimental | A novel program to train birthing parents in contingent responding with the goal of improving neurodevelopmental outcomes in infants prenatally exposed to cannabinoids. 1 personalized coaching session per month for 12 months. Receives: Behavioral: Play and Learn Strategies (PALS) Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of approached participants that are eligible for study participation
Whether a potential participant approached for study participation will eventually be consented and determined to be eligible for study participation.
Measured: 3 months
Percentage of participants that complete their final visit
Whether a birthing parent/infant dyad will complete the final coaching session when the child is 12 months of age.
Measured: 12 months following enrollment
Percentage of participants that receive a sufficient number of coaching sessions
Whether a participant will complete the sufficient number of INTACT intervention coaching sessions, defined as completion of at least 8 out of 12 coaching sessions.
Measured: 12 months following enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start6 Feb 2025
- Primary completion10 Jun 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
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 Developmental DelayStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- A single-arm pilot study to assess feasibility of study procedures.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IDeA States Pediatric Clinical Trials Network
- Sponsor type
- Research network
- Collaborators
- University of New Mexico, University of Vermont, Avera Research Institute, National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Jessie Maxwell, MD, Principal investigator, University of New MexicoLeigh-Anne Cioffredi, MD, Principal investigator, University of VermontMaria Barber, DO, Principal investigator, Avera Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423664
- Sponsor's protocol ID
- 276534
- Other IDs
- U24OD024957
- Acronym
- INTACT
- Status last verified
- Jun 2025
- First submitted
- 16 May 2024
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will conduct this trial in accordance with the following publication and data sharing policies and regulations: NIH Public Access Policy. It requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for publication. ECHO ISPCTN Publications and Presentations Policy. It ensures accurate, responsible, and efficient communication of findings from ECHO ISPCTN clinical trials. NIH Data Sharing Policy and the policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Resulting Information Submission Rule. Other researchers may request data from this trial by contacting Song Ounpraseugh, PhD, at the ISPCTN Data Coordinating and Operations Center (DCOC).
Publications
Maxwell JR, Cioffredi LA, Talavera-Barber MM, Henry M, Beauman S, Hittson A, McCoy M, Chassereau L, Jin J, Abraham PA, Fu LY, Raissy H, Snowden JN. The protocol for a pilot feasibility trial of Improving Neurodevelopmental ouTcomes After prenatal Cannabinoid in uTero exposure (INTACT) study for a multi-center trial. PLoS One. 2025 May 12;20(5):e0322035. doi: 10.1371/journal.pone.0322035. eCollection 2025.
PubMed 40354465
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Feasibility Trial of Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure (INTACT)
- ClinicalTrials.gov ID
- NCT06423664
- Acronym / sponsor ID
- INTACT / 276534
- Conditions
- Developmental Delay
- Keywords
- Behavioral health intervention, Prenatal substance exposure, Neurodevelopmental outcomes, Pediatric intervention, Developmental disorders, Pediatric health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- IDeA States Pediatric Clinical Trials NetworkResearch network
- Collaborators
- University of New Mexico, University of Vermont, Avera Research Institute, National Institutes of Health (NIH)
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- 10 Jun 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 21 May 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.
The INTACT trial is a multisite pilot feasibility study aimed at testing the effectiveness of the INTACT Intervention program in improving neurodevelopmental outcomes in infants prenatally exposed to cannabinoids. The trial will enroll 20 birthing parent/infant dyads across three sites and will evaluate feasibility endpoints rather than clinical outcomes. The study duration is 22 months, including study start-up, enrollment and intervention, and data analysis and manuscript preparation.
Detailed description
The INTACT trial is designed to address the need for interventions to improve neurodevelopmental outcomes in infants exposed to cannabinoids in utero. It is a multi-site pilot study conducted across three Institutional Development Award (IDeA) States Pediatric Clinical Trials Network (ISPCTN) sites. The trial aims to evaluate the feasibility of the INTACT Intervention program, which focuses on training birthing parents in contingent responding to promote early language, cognitive, and social development in their infants.
The study intervention consists of 12 monthly INTACT intervention coaching sessions, each comprising online module completion followed by personalized coaching sessions with interventionists certified to deliver the Play and Learn Strategies (PALS) methodology, which forms the basis for the INTACT intervention. The online modules focus on strengthening effective parenting practices, while the coaching sessions guide birthing parents in contingent responding techniques, such as reading infant signals and responding with warm and sensitive behaviors. There are three objectives for this study, examining 1) Participant Recruitment, 2) Participant Completion, and 3) Participant Adherence.
Objective 1 examines if birthing parents can be recruited and enrolled in the study. The endpoint of this objective is the percentage of potential participants approached for the study that are consented and determined to be eligible for study participation.
Objective 2 evaluates participant completion, as measured by the percent of birthing parent/infant dyads that complete the coaching session scheduled when the child is 12 months of age.
Objective 3 evaluates the number of individual INTACT intervention coaching sessions completed.
The study duration is planned for 22 months, including 1-4 months for study development and start-up, 3 months for enrollment, 12 months for the intervention, and 3 months for data organization, clean-up, and manuscript preparation.
The INTACT trial will not assess clinical outcomes but will inform the design of a future larger-scale clinical trial to evaluate the effectiveness of the INTACT Intervention program in improving neurodevelopmental outcomes in infants prenatally exposed to cannabinoids.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-arm pilot study to assess feasibility of study procedures.
| Arm | Type | Receives |
|---|---|---|
| Personalized coaching sessions | Experimental | Behavioral: Play and Learn Strategies (PALS) ProgramA novel program to train birthing parents in contingent responding with the goal of improving neurodevelopmental outcomes in infants prenatally exposed to cannabinoids. 1 personalized coaching session per month for 12 months. |
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Birthing Parent
- Age of majority, as defined by the state of residency
- Cannabinoid use during pregnancy confirmed with self-report
- Have the ability to speak, read, and understand English
- Birthing parent who delivered at one of the hospitals where study team members have clinical privileges to access medical records
Key exclusion criteria (8 listed)
- Birthing Parent
- Other illicit drug use, excluding cannabinoids, during pregnancy (such as heroin or cocaine) per self-reported or toxicology results
- Opiate use (prescribed or unprescribed) per self-report or toxicology results during this pregnancy
- Prolonged hospitalization following delivery longer than 7 days
- Infant
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 |
|---|---|---|
| Play and Learn Strategies (PALS) ProgramAlso: ePALSMonthly modules and personalized coaching sessions designed to strengthen maternal responsiveness and sensitivity which, in turn, improves infant social-emotional behavior and development outcomes. | Behavioural | Personalized coaching sessions |
Primary outcome
Percentage of approached participants that are eligible for study participation
Time frame: 3 months
Whether a potential participant approached for study participation will eventually be consented and determined to be eligible for study participation.
Percentage of participants that complete their final visit
Time frame: 12 months following enrollment
Whether a birthing parent/infant dyad will complete the final coaching session when the child is 12 months of age.
Percentage of participants that receive a sufficient number of coaching sessions
Time frame: 12 months following enrollment
Whether a participant will complete the sufficient number of INTACT intervention coaching sessions, defined as completion of at least 8 out of 12 coaching sessions.
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 24 Jun 2025.
- Derived from this study: PubMed 40354465Maxwell JR, Cioffredi LA, Talavera-Barber MM, Henry M, Beauman S, Hittson A, McCoy M, Chassereau L, Jin J, Abraham PA, Fu LY, Raissy H, Snowden JN. The protocol for a pilot feasibility trial of Improving Neurodevelopmental ouTcomes After prenatal Cannabinoid in uTero exposure (INTACT) study for a multi-center trial. PLoS One. 2025 May 12;20(5):e0322035. doi: 10.1371/journal.pone.0322035. eCollection 2025.
- Individual participant dataSharing planned: Yes. We will conduct this trial in accordance with the following publication and data sharing policies and regulations: NIH Public Access Policy. It requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for publication. ECHO ISPCTN Publications and Presentations Policy. It ensures accurate, responsible, and efficient communication of findings from ECHO ISPCTN clinical trials. NIH Data Sharing Policy and the policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Resulting Information Submission Rule. Other researchers may request data from this trial by contacting Song Ounpraseugh, PhD, at the ISPCTN Data Coordinating and Operations Center (DCOC).
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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.
Jessie Maxwell, MD principal investigator
University of New Mexico
Leigh-Anne Cioffredi, MD principal investigator
University of Vermont
Maria Barber, DO principal investigator
Avera Research Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Play and Learn Strategies (PALS) Program in people with Developmental Delay, run by IDeA States Pediatric Clinical Trials Network at 3 sites 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 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Song Ounpraseuth, PhD ((501) 686-5647, STOunpraseuth@uams.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of approached participants that are eligible for study participation (time frame: 3 months). 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 NCT06423664, 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 24 Jun 2025.