- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06627777
From Toddler to Early Adolescent Emotion Regulation Strategies
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Children (10 to 15 years) will be invited to come to a 1.5 hour laboratory assessment with a parent (most likely, mothers). We will gather parent-reported and children's self-reported avoidant and engaged cognitive ER strategies, worded with third or first person, respectively. Short form versions will be used to reduce burden for children. The Emotion Regulation Questionnaire for Children and Adolescents provides a 6 item reappraisal scale and a 4 item expressive suppression scale. The Avoidance and Fusion Questionnaire for Youth - Short Form provides an 8-item measure of experiential avoidance. The extended version of the Children's Response Styles Questionnaire provides a 5 item scale of problem-solving (also, "reflection") and a 5 item scale of rumination (also, "brooding"). Mothers will complete the Children's Responses to Feelings Checklist, which asks about these ER strategies in response to specific emotions, to examine specificity to threat (uncertainty/fear).
The investigators will also assess in-vivo use of cognitive ER strategies by using an ER strategy interview after children experience uncertainty via laboratory procedures. Children will watch a 2-minute clip from a live-action movie validated to elicit emotion in the domain of threat with school-aged children. The primary experimenter will interview the child about the cognitive ER strategies they used using open-ended questions with subsequent prompts to allow reports of multiple strategies. The primary experimenter will then ask closed-ended (yes/no) interview questions about each of the cognitive ER strategies of focus. Children will also complete two 5 minute tasks from the Laboratory Temperament Assessment Battery - Middle Childhood Version with established reliability and validity in the domain of threat. In the Storytelling task, the experimenter will instruct the child to stand and tell a story about the previous day in front of them and an unfamiliar research assistant (RA), enacting a series of standardized pauses and prompts until the child indicates they are finished. In the Mask episode, the child enters a room to see an adult RA wearing a mask with an exaggerated face. The RA completes a standardized script of statements and pauses, finally taking off the mask and engaging the child in a friendly manner. The primary experimenter will repeat the ER strategy interview for the tasks. Auxiliary ER-relevant outcomes may supplement the primary focus on cognitive ER strategies. Behavioral tasks (Storytelling, Mask) can be coded for behavioral ER strategies (distraction, self-soothing, bids to experimenter). The investigators possess the necessary equipment and software for recording and analysis of children's ECG and respiration to serve as physiological indicators of ER. As an additional indicator of family emotional environment, the child and mother will be prompted to converse about the activities in the lab.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Ohio
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Oxford, Ohio, United States, 45056
- Miami University Department of Psychology
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Family participated in previous phases of this ongoing longitudinal study
- Child was 35-42 months old for the age 3 assessment (pre-existing data)
- Child is between 10 and 15 years of age for proposed data collection
- Mothers were older than 18 years of age at original enrollment (pre-existing data).
- Mothers were able to complete study procedures in English.
Exclusion Criteria:
- Informed consent/assent is declined
- Child diagnosed with a developmental disability or chronic health condition related to deviations in expected emotional development.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Emotion regulation observation in early adolescence
All children will experience brief standardized laboratory tasks according to the same protocol.
|
Children will watch a 2-minute clip from a live-action movie and complete Storytelling and Mask tasks from the Laboratory Temperament Assessment Battery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emotion Regulation Questionnaire for Children and Adolescents
Time Frame: 3 minutes (at 1.5 hour laboratory visit)
|
Parent- and child self-report versions of this survey measure, including 6-item Reappraisal subscale and 4-item Expressive Suppression subscale
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3 minutes (at 1.5 hour laboratory visit)
|
|
Avoidance and Fusion Questionnaire for Youth-Short Form
Time Frame: 2 minutes (at 1.5 hour laboratory visit)
|
Parent- and child self-report versions of this survey measure, which provides an 8-item subscale of Experiential Avoidance
|
2 minutes (at 1.5 hour laboratory visit)
|
|
Children's Response Styles Questionnaire
Time Frame: 2 minutes (at 1.5 hour laboratory visit)
|
Parent- and child self-report versions of this survey measure, which provides a 5-item subscale of Problem-Solving/Reflection, and a 5-item subscale of Rumination/Brooding
|
2 minutes (at 1.5 hour laboratory visit)
|
|
Avoidant emotion regulation strategies to threat
Time Frame: 1.5 hours (at laboratory visit)
|
Interview responses regarding use of expressive suppression, experiential avoidance, and rumination/brooding strategies
|
1.5 hours (at laboratory visit)
|
|
Engaged emotion regulation strategies
Time Frame: 1.5 hours (at laboratory visit)
|
Interview responses regarding use of reappraisal and problem-solving/reflection strategies
|
1.5 hours (at laboratory visit)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Electrocardiogram
Time Frame: 1.5 hours over the course of laboratory visit
|
Respiratory sinus arrhythmia (RSA) will be derived as a metric of variance in interbeat intervals at rate of respiration, exhibited during laboratory tasks
|
1.5 hours over the course of laboratory visit
|
|
Children's Responses to Feelings Checklist
Time Frame: 1.5 hours (at laboratory visit)
|
Present versus absent responses will indicate parents' perception that children use particular emotion regulatory strategies within specific emotional domains (happiness, anger, fear/uncertainty [threat])
|
1.5 hours (at laboratory visit)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Elizabeth J Kiel Luebbe, Ph.D., Miami University
Study record dates
Study Major Dates
Study Start (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIHKielR032024
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
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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