Psychological TraumaNCT07283471
Facilitating Developmental Interactions With Children in Out-of-Home Care
A study testing The Developmental Interaction Workshop Series (DIWS) in people with Psychological Trauma, run by Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Psychological Trauma
- What is being tested?
- The Developmental Interaction Workshop Series (DIWS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2026to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Children 7 years of age or younger living in agencies participating in the Developmental Interactions Workshop Series
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Enriching Relational Environments by Using Purposeful Interactions and Building Developmental Relationships With Children in Out of Home Care
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
Read more
- 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.
Read the 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
- Being tested
- The Developmental Interaction Workshop Series (DIWS)
- Keywords
- trauma, children, out-of-home care
- Medical subject headings
- Psychological Trauma, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Developmental Interaction Workshop Series (DIWS)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: The Developmental Interaction Workshop Series (DIWS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
This self-report measure Goal Commitment is adapted for the current program goal from the Goal Commitment Scale (Klein, H. J., Wesson, M. J., Hollenbeck, J. R., Wright, P. M., \& DeShon, R. P. (2001). Organizational Behavior and Human Decision Processes, 85(1), 32-55. The 5 point response scale on which respondents rate their agreement with the four items ranges from 0 =Not at all to 4=Completely yielding scores ranging from 0 to 16 with higher numbers indicating higher commitment.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Psychological TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Deborah Sellers, PhD, Principal investigator, Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07283471
- Sponsor's protocol ID
- 141953
- Other IDs
- R01HD109329
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 11341816Shelton, 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enriching Relational Environments by Using Purposeful Interactions and Building Developmental Relationships With Children in Out of Home Care
- ClinicalTrials.gov ID
- NCT07283471
- Acronym / sponsor ID
- 141953
- Conditions
- Psychological Trauma
- Keywords
- trauma, children, out-of-home care
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Developmental Interaction Workshop Series | Other | Behavioral: The Developmental Interaction Workshop Series (DIWS)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. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Children 7 years of age or younger living in agencies participating in the Developmental Interactions Workshop Series
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Developmental Interaction Workshop Series |
Primary outcome
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
Time frame: 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.
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.
1 secondary outcome
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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Background: PubMed 11341816Klein 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.
- BackgroundShelton, 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Deborah Sellers, PhD principal investigator
Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Developmental Interaction Workshop Series (DIWS) in people with Psychological Trauma, run by Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07283471, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.