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

NCT04594902 | Active Not Recruiting DMC

• 2 other identifiers: #1086961R01HD102201-01
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Early Childhood Development; Behavior Problems

Outcome Measures

Primary Outcomes (1)

• Infant-Toddler Social and Emotional Assessment (ITSEA)

  The ITSEA is a 166-item parent-report measure of the frequency of specific behaviors (e.g., temper tantrums) in 12- to 36-month-olds. Participants will score their child behavior on a scale of 0-2 (0 Not true/Rarely, 2 Somewhat True/Sometimes and 3 Very True/Often). The higher the score, the higher the child is on behavior problems. The Externalizing scale will be an indicator of infant behavior. The higher the score the higher child's behavior problems.

  Change from week 0 to weeks 8, 24, 40, and 56

Secondary Outcomes (26)

• Wechsler Abbreviated Scale of Intelligence Second Edition (WASI-II)

  Screen

• Brief Infant-Toddler Social Emotional Assessment (BITSEA)

  Screen

• Ages and Stages Questionnaire-Third Edition (ASQ-III)

  Week 0

• Dyadic Parent-Child Interaction Coding System-IV (DPICS-4)

  Change from weeks 0 to week 8, 24, 40, and 56

• Early Childhood Behavior Questionnaire-Very Short Form (ECBQ)

  Change from weeks 0 to week 8, 24, 40, and 56

Study Arms (2)

Infant Behavior Program (IBP)

EXPERIMENTAL

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.

Behavioral: Infant Behavior Program (IBP)

Enhanced Pediatric Primary Care (EPPC)

ACTIVE COMPARATOR

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.

Other: Enhanced Pediatric Primary Care (EPPC)

Interventions

Infant Behavior Program (IBP) BEHAVIORAL

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.

Infant Behavior Program (IBP)

Enhanced Pediatric Primary Care (EPPC) OTHER

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.

Enhanced Pediatric Primary Care (EPPC)

Eligibility Criteria

• Age: 12 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida International University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Nicklaus Children's Hospital f/k/a Miami Children's Hospital: collaborator

Study Sites (2)

South Miami Children's Clinic

Miami, Florida, 33143, United States

Location

Nicklaus Children's Hospital

Miami, Florida, 33155, United States

Location

Related Publications (8)

• Bagner DM, Coxe S, Hungerford GM, Garcia D, Barroso NE, Hernandez J, Rosa-Olivares J. Behavioral Parent Training in Infancy: A Window of Opportunity for High-Risk Families. J Abnorm Child Psychol. 2016 Jul;44(5):901-12. doi: 10.1007/s10802-015-0089-5.

  PMID: 26446726 BACKGROUND

• Heymann P, Heflin BH, Baralt M, Bagner DM. Infant-directed language following a brief behavioral parenting intervention: The importance of language quality. Infant Behav Dev. 2020 Feb;58:101419. doi: 10.1016/j.infbeh.2019.101419. Epub 2020 Jan 9.

  PMID: 31927404 BACKGROUND

• Garcia D, Rodriquez GM, Hill RM, Lorenzo NE, Bagner DM. Infant Language Production and Parenting Skills: A Randomized Controlled Trial. Behav Ther. 2019 May;50(3):544-557. doi: 10.1016/j.beth.2018.09.003. Epub 2018 Sep 11.

  PMID: 31030872 BACKGROUND

• Morningstar M, Garcia D, Dirks MA, Bagner DM. Changes in parental prosody mediate effect of parent-training intervention on infant language production. J Consult Clin Psychol. 2019 Mar;87(3):313-318. doi: 10.1037/ccp0000375. Epub 2018 Dec 27.

  PMID: 30589352 BACKGROUND

• Blizzard AM, Barroso NE, Ramos FG, Graziano PA, Bagner DM. Behavioral Parent Training in Infancy: What About the Parent-Infant Relationship? J Clin Child Adolesc Psychol. 2018;47(sup1):S341-S353. doi: 10.1080/15374416.2017.1310045. Epub 2017 Apr 17.

  PMID: 28414546 BACKGROUND

• Ramos G, Blizzard AM, Barroso NE, Bagner DM. Parent Training and Skill Acquisition and Utilization Among Spanish- and English-Speaking Latino Families. J Child Fam Stud. 2018 Jan;27(1):268-279. doi: 10.1007/s10826-017-0881-7. Epub 2017 Oct 17.

  PMID: 29456439 BACKGROUND

• Bagner DM, Garcia D, Hill R. Direct and Indirect Effects of Behavioral Parent Training on Infant Language Production. Behav Ther. 2016 Mar;47(2):184-97. doi: 10.1016/j.beth.2015.11.001. Epub 2015 Nov 14.

  PMID: 26956651 BACKGROUND

• Bagner DM, Rodriguez GM, Blake CA, Rosa-Olivares J. Home-Based Preventive Parenting Intervention for at-Risk Infants and Their Families: An Open Trial. Cogn Behav Pract. 2013 Aug 1;20(3):334-348. doi: 10.1016/j.cbpra.2012.08.001.

  PMID: 25414568 BACKGROUND

MeSH Terms

Conditions

Mental Disorders

Study Officials

• Daniel M Bagner, PhD

  Florida International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Independent evaluators and coders assessing response over time are kept unaware of the condition to which each participant is assigned.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized control trial in which participants are randomly assigned to either receive the Infant Behavior Program (IBP) or the Enhanced Pediatric Primary Care (EPPC).

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 20, 2020
• Study Start: March 8, 2021
• Primary Completion (Estimated): September 7, 2026
• Study Completion (Estimated): September 7, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Deidentified data for the entire database will be made available for data sharing after the main findings from the final dataset have been accepted for publication.
• Access Criteria: Users will be provided with the data under a data-sharing agreement which specifies that: (1) data will be used only for research purposes; (2) data will be stored confidentially and securely; and (3) data will be destroyed after analyses are completed. PI Bagner and collaborators will identify where the data will be available and how to access the data in any publications and presentations using these data.

Locations

US (2)