NCT07283471

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Jan 2026Jul 2026

First Submitted

Initial submission to the registry

December 11, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 15, 2025

Completed
17 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

January 28, 2026

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

December 11, 2025

Last Update Submit

January 27, 2026

Conditions

Keywords

traumachildrenout-of-home care

Outcome Measures

Primary Outcomes (1)

  • Change in Frequency of Caregiving Practices over the past week from prior to attending the Developmental Interaction Workshop Series to 4 weeks after the final workshop

    This self-report measure of staff practices is adapted for the residential child care setting from the Involvement subscale of the Alabama Parenting Questionnaire (Shelton, Frick, \& Wootton, 1996, Journal of Clinical Child Psychology, 253:317-329). The 7-point response scale for each of the 13 items ranges from 0=not at all to 6=Very Often, yielding overall scores ranging from 0=not at all to 78=very often on all items with higher numbers indicating more positive practices.

    From completion of the staff survey 2 weeks prior to the initial workshop to 4 weeks after the final workshop. The two parts of the workshop are delivered 3-4 weeks apart.

Secondary Outcomes (1)

  • Change in commitment to the goal of increasing developmental interactions currently, from before attending the Developmental Interaction Workshop Series to 4 weeks after the final workshop

    From completion of the staff survey 2 weeks prior to the initial workshop to 4 weeks after the final workshop. The two parts of the workshop are delivered 3-4 weeks apart.

Study Arms (1)

Developmental Interaction Workshop Series

OTHER

The two-part Developmental Interactions Workshop series is designed for adults who work with children in out-of-home care settings and the people who supervise these adults. Part 1 and Part 2 of this series include two sessions each: one session for direct caregivers and their supervisors, and one additional session for supervisors only. Part 2 of the workshop series should take place 3-4 weeks after Part 1. The focus of these workshops is helping caregivers to take advantage 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. Supervisor only sessions will focus on the ways in which they can support and assist their staff to intentionally create these moments with children.

Behavioral: The Developmental Interaction Workshop Series (DIWS)

Interventions

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.

Developmental Interaction Workshop Series

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Residential care staff in agencies participating in the Developmental Interactions Workshop Series
  • Children 8 years of age or older living in agencies participating in the Developmental Interactions Workshop Series

You may not qualify if:

  • Children 7 years of age or younger living in agencies participating in the Developmental Interactions Workshop Series

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cornell University

Ithaca, New York, 14853, United States

Location

Related Publications (2)

  • Klein HJ, Wesson MJ, Hollenbeck JR, Wright PM, DeShon RP. The Assessment of Goal Commitment: A Measurement Model Meta-Analysis. Organ Behav Hum Decis Process. 2001 May;85(1):32-55. doi: 10.1006/obhd.2000.2931.

    PMID: 11341816BACKGROUND
  • Shelton, K. K., Frick, P. J., & Wootton, J. (1996). Assessment of parenting practices in families of elementary school-age children. Journal of clinical child psychology, 25(3), 317-329.

    BACKGROUND

MeSH Terms

Conditions

Psychological TraumaWounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Deborah Sellers, PhD

    Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: The intervention is a workshop that includes two sessions for staff and supervisors together and two additional sessions just for supervisors. The goal of the workshop series is to help staff and supervisors who care for children in residential settings learn how to provide more developmentally enriching interactions for the children in their care, who frequently suffer from the effects of maltreatment and/or neglect or other adverse childhood experiences. For these children, the accumulation of consistent interactions with adults who are attuned to the child's needs and feelings, listen to and respect those needs and feelings, and help the children learn to cope with those needs and feelings provide pathways to more normative developmental trajectories.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2025

First Posted

December 15, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

January 28, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

The DIWS will be completed at 2-3 agencies that provide residential treatment for children. Given the magnitude of the commitment to implementing the Developmental Interaction Workshop Series at an agency, it is not possible to fully guarantee masking the agencies who participate. Thus, the potential to identify individuals in participant data is increased, particularly if information (staff versus supervisor, age and gender of the child) crucial to proper use of the data is included.

Locations