The PANTHERS (Parents and iNfants Together in Home-based Early Remote Services) Project

Florida International University (FIU)

Status: Enrolling

Conditions: Early Childhood Development; Behavior Problems

Treatments: Behavioral: Infant Behavior Program (IBP); Other: Enhanced Pediatric Primary Care (EPPC)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04594902

1R01HD102201-01 (U.S. NIH Grant/Contract)

#108696

Details and patient eligibility

About

The PANTHERS (Parents And iNfants Together in Home-based Early Remote Services) Projects is a study funded by the National Institute of Child Health and Human Development to evaluate the efficacy and maintenance of a remote home-based preventive intervention, the Infant Behavior Program (IBP), to decrease behavior problems in infants from high-risk families. All families will participate in five remote evaluations in their home, and families will also receive 6 remote treatment sessions of either the IBP or the EPPC. All participant procedures will be conducted remotely.

Full description

Research Design: The proposed study will evaluate the efficacy and maintenance of a remote home-based preventive intervention, the Infant Behavior Program (IBP), to decrease behavior problems in infants from high-risk families. Specifically, the investigators propose to conduct a randomized controlled trial to demonstrate its efficacy and maintenance in reducing behavior problems and increasing infant regulation relative to an enhanced pediatric primary care (EPPC) active control condition. Assessments will occur at pre (week 0)- and post (week 8)-intervention assessments (approximately 2 months apart), as well as at 4-month (week 24) , 8 -month (week 40), and 12-month (week 56) follow-up assessments.

Procedures: Families will be primarily recruited from pediatric primary care centers and will be randomized to receive six sessions of either IBP or EPPC in their home. Families also will participate in five remote home-based assessments.

Risks and Benefits: Families may experience risk from a breach in confidentiality as participants reveal sensitive information and there are risks in breach of confidentiality due to videoconferencing methods, in particular if study staff become aware of abuse or neglect situations. Families may experience discomfort when answering personal questions. Benefits to families could include providing families with information that can assist in caring for their child, and instilling new parenting strategies that are designed to outlast treatment.

Knowledge: This study will provide information about the efficacy of a remote home-based preventive intervention to improve infant behavior and regulation.

Enrollment: 288 estimated patients

Sex: All

Ages: 12 to 18 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Infants ages 12 to 18 months and at least one primary caretaker, who is at least 18-years-old and in most cases will be the mother
• Elevated score (> 75th percentile) on the problem scale of the Brief Infant-Toddler Social and Emotional Assessment (BITSEA; Briggs-Gowan et al., 2004)
• An English-speaking or Spanish-speaking primary caregiver.

Exclusion criteria

• Infants with major sensory impairment (e.g., deafness blindness) or several problems that impair mobility (e.g., cerebral palsy)
• Significant cognitive delay in the primary caregiver (i.e., estimated IQ score < 70 on the vocabulary subtest of the Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II) for those speaking English or an average standard score < 4 on the vocabulary subtest of the Escala de Inteligencia Wechsler Para Adultos - Third Edition (EIWA-III) for those speaking Spanish)
• Families involved with child protection services, which is expected to be low based on our pilot trials

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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288 participants in 2 patient groups

Infant Behavior Program (IBP)

Experimental group

Description:

Infant Behavior Program (IBP) is a home-based adaptation of the Child-Directed Interaction (CDI) phase of Parent-Child Interaction Therapy (PCIT), an evidence-based intervention for early externalizing problems. Consistent with recommendations we maintained core features of CDI and addressed the unique developmental needs of infants. All IBP sessions will completed remotely.

Treatment:

Behavioral: Infant Behavior Program (IBP)

Enhanced Pediatric Primary Care (EPPC)

Active Comparator group

Description:

Families in EPPC will receive six one-hour home visits where they will receive information about normative developmental and health expectations for their infant. Specifically, therapists will provide education on six topics: (1) cognitive and emotional development; (2) language and social development; (3) safety; (4) feeding and nutrition; (5) sleep; and (6) fitness and activity. All EPPC sessions will completed remotely.

Treatment:

Other: Enhanced Pediatric Primary Care (EPPC)