What is the mechanism of action of this treatment?

Common treatments for Early Childhood Development, such as those in the Infant Behavior Program (IBP), utilize behavioral modification techniques delivered through remote sessions. These treatments focus on positive reinforcement, problem-solving skills training, and enhancing parent-child interactions. These mechanisms are vital as they help shape a child's behavior in a supportive environment, leading to improved emotional and social outcomes. Remote delivery ensures greater accessibility and consistency, which is crucial for early intervention and long-term developmental benefits.

What side effects are associated with this type of intervention?

Common treatments for early childhood development, such as behavioral modification through remote sessions like those in the Infant Behavior Program (IBP), generally have minimal physical side effects. However, potential side effects may include increased stress or frustration for both the child and caregivers due to the demands of the program. Additionally, the effectiveness of remote sessions can be influenced by the family's ability to engage with the technology and the program's requirements, which may lead to inconsistent outcomes. It is important for caregivers to maintain open communication with healthcare providers to address any concerns that arise during the treatment.

What prior FDA approvals exist?

The FDA has approved various medications for pediatric conditions, but specific approvals for early childhood development focusing on behavioral modification through remote sessions are limited. Behavioral interventions, such as those studied in the Infant Behavior Program (IBP), typically do not involve FDA-approved drugs but rather rely on structured behavioral therapy. These interventions aim to address behavior problems in infants through techniques like cognitive-behavioral therapy (CBT) and parent training, often delivered remotely. While medications like SSRIs and antipsychotics are approved for related conditions in older children, early childhood development interventions primarily emphasize non-pharmacologic approaches.

What other types of research exist?

Promising alternatives to the Infant Behavior Program for early childhood development include: 1) Triple P Online Brief, a low-intensity online positive parenting program that has shown efficacy in reducing disruptive behavior in children. 2) TEACCH (Treatment and Education of Autistic and Communication Handicapped Children), which has been effective in improving social communication in children with autism. 3) Self-guided behavioral skills training programs that teach parents to engage in nurturing behaviors, such as imitating infant vocalizations, through online asynchronous training.

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Home-Based Infant Behavior Intervention for Behavioral Problems (PANTHERS Trial)

N/A

Recruiting

Led By Daniel M Bagner, PhD

Research Sponsored by Florida International University

Eligibility Criteria Checklist

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

Must have

Be younger than 18 years old

Must not have

Infants with major sensory impairment (e.g., deafness blindness) or several problems that impair mobility (e.g., cerebral palsy)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up repeated at weeks 0, 8, 24, 40, and 56.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a remote program called the Infant Behavior Program (IBP) to help parents from high-risk families improve their baby's behavior. The program teaches parents new ways to handle their baby's behavior through several remote sessions. The Infant Behavior Program (IBP) is a home-based adaptation of Parent-Child Interaction Therapy designed to improve parenting skills and reduce early childhood behavior problems.

Who is the study for?

The PANTHERS Project is for infants aged 12 to 18 months with behavior problems and their primary caretakers, who must be at least 18 years old. Caretakers should speak English or Spanish and have no significant cognitive delays. Families involved with child protection services or infants with major sensory impairments or severe mobility issues cannot participate.

What is being tested?

This study tests a remote home-based program called the Infant Behavior Program (IBP) against Enhanced Pediatric Primary Care (EPPC). It aims to reduce behavioral issues in high-risk families' infants through six treatment sessions, all conducted remotely.

What are the potential side effects?

Since this trial involves non-medical interventions focused on behavior management and development support, traditional side effects associated with medications are not applicable. However, there may be indirect effects related to changes in family dynamics or stress.

Eligibility Criteria

Exclusion Criteria

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

Select...

My child has a major sensory impairment or mobility issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ repeated at weeks 8, 24, 40, and 56.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~repeated at weeks 8, 24, 40, and 56.

This trial's timeline: 3 weeks for screening, Varies for treatment, and repeated at weeks 8, 24, 40, and 56. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Infant-Toddler Social and Emotional Assessment (ITSEA)

Secondary study objectives

Abbreviated Multidimensional Acculturation Scale (AMAS)

Adult Executive Functioning Inventory (ADEXI)

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

+23 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Infant Behavior Program (IBP)Experimental Treatment1 Intervention

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.

Group II: Enhanced Pediatric Primary Care (EPPC)Active Control1 Intervention

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.

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Early Childhood Development, such as those in the Infant Behavior Program (IBP), utilize behavioral modification techniques delivered through remote sessions. These treatments focus on positive reinforcement, problem-solving skills training, and enhancing parent-child interactions. These mechanisms are vital as they help shape a child's behavior in a supportive environment, leading to improved emotional and social outcomes. Remote delivery ensures greater accessibility and consistency, which is crucial for early intervention and long-term developmental benefits.

ATTACHMENT-BASED INTERVENTION FOR SUBSTANCE-USING MOTHERS: A PRELIMINARY TEST OF THE PROPOSED MECHANISMS OF CHANGE.Integrated programs for mothers with substance abuse issues and their children: a systematic review of studies reporting on child outcomes.Outpatient psychotherapy for mothers--first empirical results.