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Behavioral Intervention

PALS Program for Developmental Delay (INTACT Trial)

N/A

Waitlist Available

Led By Maria Barber, DO

Research Sponsored by IDeA States Pediatric Clinical Trials Network

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Infant must be a term infant at birth (>37 weeks' gestation)

Be younger than 18 years old

Must not have

Infant must not have received any major surgical intervention during the birth hospitalization or required a prolonged birth hospitalization (prolonged hospitalization being any hospitalization longer than 7 days)

Infant must not have major birth defect(s) including physical anomalies such as limb malformations/absence of limbs or chromosomal abnormalities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months following enrollment

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing a program to see if it can help improve the development of babies who were exposed to cannabinoids before birth. They will enroll 20 parent and baby pairs at three different locations and will

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves educational and developmental strategies rather than medications, there are no direct medical side effects expected from participating.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My baby was born full-term.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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My infant does not have major birth defects or physical/chromosomal abnormalities.

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My infant was not diagnosed with brain-related conditions or infections at birth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months following enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months following enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months following enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of approached participants that are eligible for study participation

Percentage of participants that complete their final visit

Percentage of participants that receive a sufficient number of coaching sessions

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Personalized coaching sessionsExperimental Treatment1 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.

0 / 4Eligibility criteria met