Clinical trial NCT04594902: The PANTHERS (Parents and iNfants Together in Home-based Early Remote Services) Project
Official title: The PANTHERS (Parents and iNfants Together in Home-based Early Remote Services) Project
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Early Childhood Development
Behavior Problems
Lead sponsor: Florida International University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Nicklaus Children's Hospital f/k/a Miami Children's Hospital
First posted: 2020-10-20
Enrollment: 288
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial in which participants are randomly assigned to either receive the Infant Behavior Program (IBP) or the Enhanced Pediatric Primary Care (EPPC).
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Infant-Toddler Social and Emotional Assessment (ITSEA)
timeFrame: Change from week 0 to weeks 8, 24, 40, and 56
Secondary outcomes:
measure: Wechsler Abbreviated Scale of Intelligence Second Edition (WASI-II)
timeFrame: Screen
measure: Brief Infant-Toddler Social Emotional Assessment (BITSEA)
timeFrame: Screen
measure: Ages and Stages Questionnaire-Third Edition (ASQ-III)
timeFrame: Week 0
measure: Dyadic Parent-Child Interaction Coding System-IV (DPICS-4)
timeFrame: Change from weeks 0 to week 8, 24, 40, and 56
measure: Early Childhood Behavior Questionnaire-Very Short Form (ECBQ)
timeFrame: Change from weeks 0 to week 8, 24, 40, and 56
measure: Laboratory Temperament Assessment Battery (Lab-TAB)
timeFrame: Change from weeks 0 to week 8, 24, 40, and 56
measure: Short-form version of the MacArthur Communicative Development Inventories
timeFrame: Change from weeks 0 to week 8, 24, 40, and 56
measure: Brief Infant Sleep Questionnaire (BISQ)
timeFrame: Change from weeks 0 to week 8, 24, 40, and 56
measure: Screen Media Use Questionnaire A
timeFrame: Week 0
measure: Screen Media Use Questionnaire B
timeFrame: Repeated at weeks 8, 24, 40, and 56.
measure: Screen Media Use Interview
timeFrame: Repeated at weeks 0, 8, 24, 40, and 56.
measure: Parenting Scale
timeFrame: Change from weeks 0 to week 8, 24, 40, and 56
measure: Parental Sensitivity/Responsivity: Global codes from the Early Parenting Coding System (EPCS)
timeFrame: Change from weeks 0 to week 8, 24, 40, and 56
measure: Positive and Negative Affective Schedule (PANAS)
timeFrame: Change from weeks 0 to week 8, 24, 40, and 56
measure: The Parenting Stress Index, Fourth Edition Short Form (PSI-SF)
timeFrame: Change from weeks 0 to week 8, 24, 40, and 56
measure: Abbreviated Multidimensional Acculturation Scale (AMAS)
timeFrame: Week 0
measure: Multidimensional Acculturative Stress Inventory (MASI)
timeFrame: Week 0
measure: Adult Executive Functioning Inventory (ADEXI)
timeFrame: Week 0
measure: NIH Cognitive Toolbox List Sorting Working Memory Test
timeFrame: Week 0
measure: Services for Children and Adolescents-Parent Interview (SCAPI)
timeFrame: Change from weeks 0 to week 8, 24, 40, and 56
measure: Technological Ease and Computer-based Habits Inventory (TECHI)
timeFrame: Week 0
measure: Therapy Attitude Inventory (TAI)
timeFrame: Week 8
measure: IBP Quiz
timeFrame: Week 8
measure: EPPC Quiz
timeFrame: Week 8
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: Change from weeks 0 to week 8, 24, 40, and 56
measure: COPING WITH TODDLERS' NEGATIVE EMOTION SCALE (CTNES)
timeFrame: Change from weeks 0 to week 8, 24, 40, and 56
Other outcomes:
Locations:
city: Miami
country: United States
facility: South Miami Children's Clinic
state: Florida
city: Miami
country: United States
facility: Nicklaus Children's Hospital
state: Florida
Study officials:
affiliation: Florida International University
name: Daniel M Bagner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.