- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07696611
Interacting With Children Training for Undergraduates
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Children interact with adults in almost every setting, including caregiving, schooling, extracurriculars, and mental health support. Adults within these roles are positioned to enhance children's growth through modeling appropriate behaviors, teaching prosocial interactions, and facilitating positive relationships with other people in their environments. Adults often require explicit instruction to reach their full potential while using these skills. The therapy context is one such capacity through which adults, and particularly caregivers, can learn relationship-enhancing strategies to bolster their interactions with children. Given the positive effects that psychological treatment can have on the caregiver-child relationship, efforts to expand teaching these skills to broader adult-child interactions are underway. One such training is Child-Adult Relationship Enhancement (CARE), which is rooted in both parent management training (PMT) and Parent-Child Interaction Therapy (PCIT). Both PMT and PCIT are types of empirically supported treatments that teach relationship enhancement and limit-setting strategies to caregivers of young children with disruptive behavior disorders. Given the wide-reaching successes of PMT and PCIT for families of children with externalizing behavior problems, substantial efforts have been made to teach PCIT skills and principles to additional audiences beyond therapy settings. Despite the success of these interventions, PCIT is ultimately a treatment intended for children between ages two and seven with clinically significant disruptive behaviors and is not designed for implementation outside of the therapy setting. In order to increase access to the behavioral principles taught through PCIT for children of a wider age range and for interactions with non-caregivers, the Child-Adult Relationship Enhancement (CARE) training protocol was created
CARE:
CARE is a preventative program that teaches any adult working with any child or adolescent ages two to 18 highly effective play therapy skills in order to mitigate the risks of disruptive behavior concerns and/or child maltreatment. CARE utilizes a trauma-informed approach so that participants can both help prevent child maltreatment and lessen the negative impacts that abuse and neglect have on children and adolescents. The primary focus of CARE is to enhance the relationship-building skills that adults bring to an adult-child interaction so that children and adolescents will be more likely to engage positively with adults and, as a result of having a warm foundation, be more willing to comply with adult requests.
Regarding CARE training format, trainings typically last for three to six hours across one to two sessions and contain both didactic and role-play portions. During didactic segments, participants learn about childhood trauma, the positive effects of play on child-adult relationship enhancement, statements to use and avoid, how to give good commands, and how to utilize selective attention. Role-play activities allow participants to practice the skills learned throughout training with each other while being coached with live feedback from training facilitators. CARE trainings are designed to be application-focused such that participants complete the training with real-world skills that they can apply during their future interactions with children and adolescents. CARE teaches adults to increase their positive skills ("P skills") and decrease their statements to avoid during interactions ("Q skills") while engaging with a child or adolescent. The P skills include Praise, Paraphrase, and Point Out. The Q skills include Quash the Need to Lead, Quit Unnecessary Questions, and Quiet the Criticisms.
CARE trainings have historically been provided and proven highly effective for professionals working in pediatric settings, including allied health professionals, pediatricians, and teachers, as well as caregivers and foster caregivers. However, one population that has received little attention within CARE literature is undergraduate students. Undergraduates are uniquely positioned to receive behavioral management and child-adult relationship enhancement trainings because many students are involved in child-oriented activities (e.g., volunteering, coaching, mentoring), others focus on child-facing careers such as teaching, medicine, and psychology, and some are caregivers themselves. Students in university settings are primed to readily absorb new information and knowledge, given that they are immersed in classroom environments and eager for skills-based curricula. However, only one previous study has examined the efficacy of CARE trainings among undergraduates. The study found that undergraduate participants significantly improved their observed usage of positive skills, recognition of those skills during coding exercises, and overall CARE knowledge following CARE trainings. The investigator noted that CARE should continue to be examined among undergraduates given that study's success and recommended implementing a true experimental design (i.e., intervention versus control group).
Method:
Participants:
All study procedures are currently under review by the Auburn University Institutional Review Board. Students will be recruited from Auburn University using the SONA Human Subject Pool Software and public advertisements. Potential participants will complete an eligibility screener through the online survey software Qualtrics prior to their enrollment in the study.
Procedures:
Eligible participants will complete an informed consent survey via Qualtrics. After informed consent is provided, participants will be randomly assigned to either the CARE training group or the psychoeducation control training group. They will also be assigned a training date. Participants in the CARE training group will attend a three-and-a-half hour in-person CARE training, while those in the psychoeducation control training group will attend a three-and-a-half hours training with information regarding child development, common childhood disorders, and general communication strategies. Regardless of their group assignment, all participants will complete three surveys via Qualtrics and two brief interactive tasks (i.e., roleplay task and coding task) when they arrive immediately before their training begins. They will also complete three surveys via Qualtrics and the same two tasks immediately after their training is finished. In total, participants are expected to spend approximately four hours participating in the study, including the informed consent process.
Hypotheses and Data Analytic Strategy:
I hypothesize that the undergraduate participants enrolled in the CARE trainings will demonstrate greater improvements in play skills, improved recognition of those skills while coding, and better knowledge of CARE principles compared to the control group. I also predict that participants' baseline motivation will predict their play skills acquisition over the course of training, and that their baseline motivation will predict their post-training satisfaction, which will depend on training condition. All analyses will be conducted using IBM SPSS Statistics. The hypothesis regarding CARE training participants demonstrating more improvements over the control group will be tested using multilevel modeling. Repeated measures of the dependent variables (P skills, Q skills, coding reliability, CARE quiz scores) will be nested within Level 1, and the intervention condition (CARE, active control), the interaction between condition and time (pre-training, post-training), and the two-way interaction between condition and time will be added to Level 2. The hypothesis regarding baseline motivation predicting skills acquisition will be investigated using two multiple linear regressions, with motivation as a predictor variable and P and Q skills as outcome variables, respectively. The hypothesis regarding baseline motivation predicting post-training satisfaction, depending on training group, will be analyzed using a moderation analysis within a multiple linear regression. The predictor variable will be motivation, the outcome variable will be satisfaction, and the interaction term between motivation and satisfaction will be used to determine if the relationship is moderated by training group. A power analysis conducted using G*POWER determined that a total of 36 participants (18 per condition) would detect a sufficiently powered effect. However, due to the possibility of attrition, 54 total participants (27 per condition) will be recruited.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kaitlyn M Wortham, MS
- Phone Number: 270-584-3460
- Email: kzw0104@auburn.edu
Study Contact Backup
- Name: Elizabeth B Knight, PhD
- Phone Number: 334-844-6486
- Email: brestev@auburn.edu
Study Locations
-
-
Alabama
-
Auburn, Alabama, United States, 36849
- Auburn University
-
Contact:
- Kaitlyn M Wortham, MS
- Phone Number: 270-584-3460
- Email: kzw0104@auburn.edu
-
Contact:
- Elizabeth B Knight, PhD
- Phone Number: 334-844-6486
- Email: brestev@auburn.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- at least 18 years old, female, fluent in English, Auburn University undergraduate student, currently or within the past year working with children in any capacity, generally available to attend a three-and-a-half hour training on a Friday afternoon
Exclusion Criteria:
- under age 18, not female, not fluent in English, not Auburn University undergraduate student, not working with children currently or within the past year in any capacity, not generally available to attend a three-and-a-half hour training on a Friday afternoon
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CARE Training
CARE is a preventative program teaching any adult working with any child highly effective play therapy skills to mitigate the risks of disruptive behavior concerns and/or child maltreatment.
The primary focus of CARE is to enhance adult relationship-building skills so that children will be more likely to engage positively with adults.
The training is approximately three-and-a-half hours in length and is comprised of didactics, roleplays, video demonstrations, and activities.
|
A preventative training program teaching play therapy skills to adults working with children to improve adult-child interactions and relationships that involves didactics, roleplays, video demonstrations, and activities.
|
|
Other: Psychoeducation Training
The Psychoeducation Training teaches general principles associated with child development as well as general, basic child interaction strategies.
It is the same duration as the experimental condition (approximately three-and-a-half hours) and will involve the same pre-training and post-training surveys and interactive tasks.
|
A training that teaches general child development principles and basic child interaction strategies.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child Interaction Skills
Time Frame: From the beginning of training to the end of training approximately three-and-a-half hours later
|
Specific positive skill statements ("P skills") and skill statements to avoid during play and interactions ("Q skills")
|
From the beginning of training to the end of training approximately three-and-a-half hours later
|
|
Coding Reliability
Time Frame: From the beginning of training to the end of training approximately three-and-a-half hours later
|
Recognition of positive skill statements ("P skills") and skill statements to avoid during play and interactions ("Q skills") during a pre-recorded video of adult and child at play
|
From the beginning of training to the end of training approximately three-and-a-half hours later
|
|
Knowledge of CARE Principles
Time Frame: From the beginning of training to the end of training approximately three-and-a-half hours later
|
Quiz assessing CARE knowledge
|
From the beginning of training to the end of training approximately three-and-a-half hours later
|
|
Situational Motivation
Time Frame: From the beginning of training to the end of training approximately three-and-a-half hours later
|
Situational Motivation Scale
|
From the beginning of training to the end of training approximately three-and-a-half hours later
|
|
Training Satisfaction
Time Frame: From the beginning of training to the end of training approximately three-and-a-half hours later
|
Satisfaction Survey
|
From the beginning of training to the end of training approximately three-and-a-half hours later
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CARE Skills Goal Criteria
Time Frame: From the beginning of training to the end of training approximately three-and-a-half hours later
|
The numbers of specific positive skill statements ("P skills") and skill statements to avoid during play and interactions ("Q skills") given by participants during a 5-minute coding window.
|
From the beginning of training to the end of training approximately three-and-a-half hours later
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
- Gurwitch RH, Messer EP, Masse J, Olafson E, Boat BW, Putnam FW. Child-Adult Relationship Enhancement (CARE): An evidence-informed program for children with a history of trauma and other behavioral challenges. Child Abuse Negl. 2016 Mar;53:138-45. doi: 10.1016/j.chiabu.2015.10.016. Epub 2015 Nov 22.
- Guay, F., Vallerand, R. J., & Blanchard, C. (2000). On the assessment of situational intrinsic and extrinsic motivation: The Situational Motivation Scale (SIMS). Motivation and Emotion, 24(3), 175-213. https://doi.org/10.1023/A:1005614228250
- Groh, L. R. (2024). Undergraduates who CARE: An Evaluation of Child Adult Relationship Enhancement (CARE) training with undergraduate students [Unpublished doctoral dissertation]. Auburn University.
- Eyberg, S. M., Nelson, M. M., Ginn, N. C., Bhuiyan, N., & Boggs, S. R. (2013). Dyadic Parent-Child Interaction Coding System (DPICS): Comprehensive Manual for Research and Training (4th ed.). PCIT International.
- Eyberg, S. M., & Funderburk, B. (2011). Parent-Child Interaction Therapy Protocol. PCIT International.
- Erdfelder, E., Faul, F., & Buchner, A. (1996). GPOWER: A general power analysis program. Behavior Research Methods, Instruments, & Computers, 28(1), 1-11. https://doi.org/10.3758/BF03203630
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00001379
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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