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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05415319
Other study ID # KielR032022
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date August 2023
Est. completion date December 2024

Study information

Verified date November 2023
Source Miami University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will examine the relation between behavioral emotion regulation (ER) strategies at toddler age 3 to cognitive ER strategies in middle childhood/pre-adolescence as part of an ongoing longitudinal study of children's typical development. Aim 1 is to test whether self-soothing/caregiver-focused and distraction behavioral ER strategies at child age 3 predict avoidant and engaging cognitive ER strategies, respectively, at a follow-up assessment to be completed when children are 8-14 years old. In a completed wave of data collection, children's ER behaviors were elicited in laboratory tasks characterized by novelty and uncertainty at age 3. Avoidant and engaged cognitive ER strategies will be assessed by children's self-report, parent-report, and interviews with children after they engage in new laboratory tasks characterized by uncertainty. Hypothesis 1a: Self-soothing/caregiver-focused toddler behavioral ER strategies will predict avoidant cognitive strategies in middle childhood/pre-adolescence. Hypothesis 1b: The toddler behavioral ER strategy of distraction will predict engaged cognitive ER strategies in middle childhood/pre-adolescence. To provide additional developmental information, Aim 2 is to test whether child age at the follow up assessment (ranging 8-14 years) moderates the relation between behavioral ER strategies at age 3 and cognitive emotion regulatory strategies in middle childhood/pre-adolescence. Hypothesis 2: Because older children will have undergone more development underlying cognitive ER strategies, relations specified in Hypotheses 1a and 1b will strengthen across older ages. Finally, the Exploratory Aim is to test theoretically-supported individual (i.e., temperament) and environmental (i.e., family emotional environment) variables as potential mediators or moderators of the relation between behavioral ER strategies at age 3 and cognitive ER strategies in middle childhood-preadolescence. The investigators expect inhibited temperament to be involved in the link between behavioral ER strategies and avoidant cognitive ER strategies, effortful control to be involved in the link between behavioral ER strategies and engaged cognitive ER strategies, and the emotional family environment to be involved in linking behavioral ER strategies to both avoidant and engaged ER strategies.


Description:

Children (8 to 14 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 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 uncertainty 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 uncertainty. 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 resembling a disfigured 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 14 Years
Eligibility 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 8 and 14 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Laboratory tasks in middle childhood/pre-adolescence
Children will watch a 2-minute clip from a live-action movie and complete Storytelling and Mask tasks from the Laboratory Temperament Assessment Battery.

Locations

Country Name City State
United States Miami University Department of Psychology Oxford Ohio

Sponsors (2)

Lead Sponsor Collaborator
Miami University University of California, Riverside

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Emotion Regulation Questionnaire for Children and Adolescents Parent- and child self-report versions of this survey measure, including 6-item Reappraisal subscale and 4-item Expressive Suppression subscale 3 minutes (at 1.5 hour laboratory visit)
Primary Avoidance and Fusion Questionnaire for Youth-Short Form 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)
Primary Children's Response Styles Questionnaire 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)
Secondary Electrocardiogram 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
Secondary Children's Responses to Feelings Checklist Present versus absent responses will indicate parents' perception that children use particular emotion regulatory strategies within specific emotional domains (happiness, anger, fear/uncertainty) 2 minutes (at 1.5 hour laboratory visit)
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