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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the PALS Program treatment for developmental delay?

The research suggests that individualized, goal-directed rehabilitation programs can improve functional outcomes in children with developmental delays, especially in areas with limited access to rehabilitation services. Additionally, home activity programs, which involve therapists and family support, show high compliance and positive parental perceptions, indicating potential benefits for children with developmental delays. ^{1 2 3 4 5}

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. Netherlands 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. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. Netherlands 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. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Home activity programs in families with children presenting with global developmental delays: evaluation and parental perceptions. [2019]

5. England 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. [2022]