PALS Program for Developmental Delay

(INTACT Trial)

Recruiting at 2 trial locations

Overseen By Song Ounpraseuth, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: IDeA States Pediatric Clinical Trials Network

Must not be taking: Opiates, Heroin, Cocaine, others

Disqualifiers: Illicit drug use, Major birth defects, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called PALS, which provides personalized coaching to help parents enhance their infants' neurodevelopment. It targets infants exposed to cannabinoids (substances from the cannabis plant) before birth. The trial examines whether monthly coaching sessions over a year can improve developmental outcomes. Ideal candidates are parents who used cannabinoids during pregnancy and have a healthy, full-term newborn without severe birth complications. Participants must have internet access and a device for video conferencing. As an unphased trial, this study offers parents a unique opportunity to contribute to research that could improve developmental support for infants exposed to cannabinoids.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, it excludes participants who used opiates or other illicit drugs during pregnancy, so it might be important to discuss your current medications with the study team.

What prior data suggests that the PALS Program is safe for infants?

Research has shown that the PALS Program, which includes personalized coaching sessions, is based on successful methods that improve infant development. While specific safety data from clinical trials on the PALS Program is not available, it employs well-established techniques focused on training parents. These techniques are generally safe, as they do not involve medication or medical procedures. The program aims to enhance communication and interaction between parents and infants, which is considered safe. The study is in the "Not Applicable" phase, indicating it is in the early stages and is testing the program's practicality rather than focusing on safety results. Although extensive safety data may not yet be available, the program is expected to be low-risk due to its non-invasive nature. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The PALS Program is unique because it focuses on personalized coaching sessions for birthing parents to improve neurodevelopmental outcomes in infants exposed to cannabinoids. Unlike standard treatments for developmental delay, which often involve medication or generalized therapies, this program emphasizes contingent responding—a tailored approach where parents learn to interact with their infants in specific, responsive ways. Researchers are excited about this method because it has the potential to directly engage and enhance the infant-parent bond, potentially leading to significant improvements in the child's development without the need for pharmaceuticals.

What evidence suggests that the PALS Program is effective for improving neurodevelopmental outcomes in infants?

Research has shown that early intervention programs like PALS can improve brain and behavior outcomes in children, especially those born prematurely. Studies have found that early parenting programs enhance development by teaching parents how to interact with their babies in ways that support growth. The PALS Program, tested in this trial, specifically helps parents improve their babies' brain health, which is crucial for children exposed to cannabis before birth. Early interventions have proven effective in addressing developmental challenges, offering hope for better infant development. In this trial, the PALS Program guides parents through personalized coaching sessions to help these infants catch up developmentally. ^{6 7 8 9 10}

Who Is on the Research Team?

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

Are You a Good Fit for This Trial?

This trial is for birthing parent/infant pairs where the infant was exposed to cannabinoids before birth and may be at risk of developmental delays. The study will involve 20 pairs across three sites.

Inclusion Criteria

Birthing Parent must have delivered at one of the hospitals where study team members have clinical privileges to access medical records

Birthing Parent must have parental custody of the infant

Birthing Parent must have the ability to speak, read, and understand English

Exclusion Criteria

My infant hasn't had major surgery or stayed in the hospital for more than a week after birth.

Birthing Parent must not have used other illicit drugs, excluding cannabinoids, during pregnancy (such as heroin or cocaine) per self-reported or toxicology results

Birthing Parent must not have used opiates (prescribed or unprescribed) per self-report or toxicology results during this pregnancy

Timeline for a Trial Participant

Study Development and Start-up

Initial phase for study development and preparation

1-4 months

Screening and Enrollment

Participants are screened for eligibility to participate in the trial

3 months

1 visit (in-person)

Intervention

Participants receive 12 monthly INTACT intervention coaching sessions

12 months

12 visits (virtual)

Data Organization and Analysis

Data organization, clean-up, and manuscript preparation

3 months

Follow-up

Participants are monitored for completion of the intervention and adherence

3 months

What Are the Treatments Tested in This Trial?

Interventions

• PALS Program

Trial Overview The INTACT trial is testing a program called Play and Learn Strategies (PALS) to see if it can help improve brain development in infants who were exposed to cannabinoids in the womb.

How Is the Trial Designed?

Group I: Personalized coaching sessions Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

IDeA States Pediatric Clinical Trials Network

Lead Sponsor

Trials

8

Recruited

2,500+

University of Vermont

Collaborator

Trials

283

Recruited

3,747,000+

University of New Mexico

Collaborator

Trials

393

Recruited

3,526,000+

Avera Research Institute

Collaborator

Trials

1

Recruited

20+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

Children with cerebral palsy show a wide range of health and functional outcomes, highlighting the need for personalized, goal-oriented management that addresses various aspects like nutrition, feeding safety, and spasticity.

Long-term success in managing cerebral palsy requires collaboration among medical professionals, social services, and educational systems, as well as the establishment of multicentered registries for better evidence-based practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurodevelopmental management strategies for children with cerebral palsy: optimizing function, promoting participation, and supporting families. Msall, ME., Park, JJ.[2009]

An individualized, goal-directed rehabilitation protocol significantly improved functional outcomes in 32 children with developmental delays over a 3-month period, as measured by various assessment scales.

The study found that while the rehabilitation goals were achieved, improvements in these goals did not directly correlate with changes in overall functional levels, highlighting the importance of caregiver involvement in the rehabilitation process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of individualized, goal directed institutional based rehabilitation programme in children with developmental delay disorders, in a region with limited rehabilitation accessibility. Mishra, K., Siddharth, V., Elhence, A., et al.[2020]

A study involving 43 infants at high risk of cerebral palsy found that one year of the COPCA program resulted in similar neurodevelopmental outcomes compared to typical infant physiotherapy, indicating both interventions are equally effective.

The outcomes for neuromotor development, cognition, and behavior were not linked to specific elements of the interventions, suggesting that a combination of different therapeutic approaches may be necessary for optimal early intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LEARN2MOVE 0-2 years, a randomized early intervention trial for infants at very high risk of cerebral palsy: neuromotor, cognitive, and behavioral outcome. Hielkema, T., Hamer, EG., Boxum, AG., et al.[2022]

In a study involving 32 children with cerebral palsy, those who received the Cognitive Orientation to daily Occupational Performance (CO-OP) approach alongside neurodevelopmental treatment (NDT) showed significant improvements in occupational performance and functional status compared to those who only received NDT.

The therapy was conducted twice a week for five weeks, and the results suggest that incorporating CO-OP into rehabilitation for children with cerebral palsy can enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of the Cognitive Orientation to daily Occupational Performance (CO-OP) approach for children with cerebral palsy: A randomized controlled trial. Kolit, Z., Ekici, G.[2023]

A study involving 41 families with children diagnosed with global developmental delay showed that a home activity program (HAP) led to high compliance, with 31 families continuing the program after 7 months.

Parental compliance with the HAP was influenced by the level of support from therapists and family size, highlighting the need for therapists to consider the stress levels of parents when implementing these programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home activity programs in families with children presenting with global developmental delays: evaluation and parental perceptions. Tétreault, S., Parrot, A., Trahan, J.[2019]

Citations

1. leed.times.uh.edu leed.times.uh.edu/pals-study

PALS Study – LEED at UH - University of Houston A remotely – delivered early parenting program, PAL Strategies (PALS), supports healthy brain and behavior outcomes in toddlers born prematurely.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12091767/

Detection of pediatric developmental delay with machine ... A prediction model built accordingly can be employed to screen the subjects who may develop DD before advanced and costly diagnoses are carried out.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1875957225001044

Effectiveness of early intervention and prediction ... In our study, fewer preterm children than full-term children exhibited improved developmental outcomes.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12279833/

Family outcomes of a parent-implemented early ... Neurodevelopmental disorders have become global public health challenges, and early interventions have been proved to be effective in mitigating the problems ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06423664/improving-neurodevelopmental-outcomes-after-prenatal-cannabinoid-in-utero-exposure

Improving Neurodevelopmental ouTcomes After Prenatal ... The trial will enroll 20 birthing parent/infant dyads across three sites and will evaluate feasibility endpoints rather than clinical outcomes.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6899448/

Neurodevelopmental delay: Case definition & guidelines for ... Data from 2009 in Australia estimated 7.0% of children ages 0–14 years met criteria for a broader definition of disability encompassing developmental delays, ...

7. ftp.spaceneedle.com ftp.spaceneedle.com/libweb/mL679A/603063/Pals%20Assessment.pdf

Pals Assessment Scores are typically compared against normative data to determine developmental status. Patterns in the scores can indicate specific areas needing ...

8. jneurodevdisorders.biomedcentral.com jneurodevdisorders.biomedcentral.com/articles/10.1186/s11689-021-09393-y

Pre-symptomatic intervention for autism spectrum disorder ... Evidence from preclinical trials suggest that intervention prior to the onset of ASD symptoms may yield more improved developmental outcomes, ...

9. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jpc.70191

Long‐Term Neurodevelopmental Outcomes of the SAFE ... Significant improvements were observed in motor and language composite scores in the SAFE group between baseline (T1) and the 3-month follow-up ...

10. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0322035

The protocol for a pilot feasibility trial of Improving ... Thus, this pilot feasibility trial will focus on birthing parent interventions modeled on PALS/ePALS with the goal of improving the infant developmental ...