NCT07283471

Facilitating Developmental Interactions With Children in Out-of-Home Care

Enriching Relational Environments by Using Purposeful Interactions and Building Developmental Relationships With Children in Out of Home Care

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Cornell University · Academic / Other
• Sex: All
• Age: 8 Years
• Healthy volunteers: Not accepted

Summary

The first goal of this single arm clinical trial is to develop the Developmental Interactions Workshop Series (DIWS). The second goal is to learn about the DIWS's acceptability, feasibility, and usefulness by implementing it in agencies who provide residential care for children. The main questions it answers are * Does participating in the DIWS help caregivers to become more capable, motivated, and purposeful about using developmental interactions in their caregiving role? * Do caregivers and children see more developmental interactions during their routine daily activities after the caregivers complete the DIWS? Caregiving staff will * Attend the DIWS * Complete surveys 2-4 before and 4-6 weeks after the DIWS * Complete telephone interviews before and after the DIWS (a subset of caregiving staff) Children in care will complete brief surveys 2-4 weeks before and 4-8 weeks after their caregiving staff attend the DIWS.

Detailed description

Most U.S. children living in residential care (RC) have debilitating impairments regulating emotions and behavior and the success of treatment efforts for these children depends principally on caregivers' capacity to provide developmentally enriching, therapeutic care. While living in RC, the adults who care for these children during the critical hours outside of formal therapy play central roles in their treatment. Yet, RC caregivers receive little education about how to meet the unique relational needs of the children they serve and lack a clear understanding of their own therapeutic role in each child's rehabilitation. In addition, the most commonly-used training programs for caregivers in RC, as well as other out-of-home care settings, cover an eclectic range of topics without a specific focus on relational skills, and few have empirical support. Ultimately, in order for RC services to optimize children's rehabilitation and mitigate the long-term sequelae of developmental trauma, it is imperative to provide opportunities for caregivers to develop skills for eliciting developmentally enriching interactions (DIs) during their ordinary care routines. Toward that goal, the investigators propose two specific aims. Aim #1: Produce a video-based Developmental Interaction Workshop Series (DIWS) that enables caregivers to repeatedly observe and practice specific forms of DI and to create opportunities to increase their frequency during daily care routines. The DIWS will include two 4-hour sessions for caregivers and supervisors together, as well as one 2-hour and one 3-hour session for supervisors. A beta version will be implemented in one Residential Care (RC) agency, revised as needed, and then fully implemented in at least two RC agencies. Aim #2: Evaluate the DIWS using mixed methods (staff and child surveys, staff interviews, and ethnography) in 2-4 RC agencies to document preliminary evidence of its impact, acceptability, and feasibility. The investigators expect the DIWS to lead (1) caregivers to become more capable, motivated, and purposeful about eliciting DIs in their caregiving role, and (2) caregivers and children to perceive a greater prevalence of DIs during routine daily activities. Individual, organizational, and implementation-related factors related to uptake will also be identified. The DIWS will provide a developmentally-informed framework for understanding and enhancing the child-adult relationships in residential and other out-of-home care settings. Mixed-method evaluation results will provide the foundation for future RCTs of the program's efficacy, inform program improvements, and facilitate its wider dissemination.

Conditions

• Psychological Trauma

Interventions

Type	Name	Description
BEHAVIORAL	The Developmental Interaction Workshop Series (DIWS)	Many children living in out-of-home care have experienced ongoing trauma, toxic stress, and adversity. These experiences have had a significant impact on children's ability to regulate their feelings and behaviors, enjoy healthy relationships, and grow along typical developmental pathways. To help these children to begin to heal from their past experiences and resume a more typical developmental trajectory, they need repetitive developmentally enriching interactions with adult caregivers. This requires caregivers with the willingness and ability to engage in frequent daily interpersonal exchanges with children that meet their emerging developmental needs and strengthen their internal resources to engage, grow, and heal. The DIWS is designed to help caregivers take advantaqe of the everyday and ordinary moments in daily life to create developmental interactions with children that help the child feel connected to others, capable, and autonomous.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2025-12-15
• Last updated: 2026-01-28

Locations

1 site across 1 country: United States