Clinical trial NCT06627777: From Toddler to Early Adolescent Emotion Regulation Strategies
Official title: From Toddler to Early Adolescent Emotion Regulation Strategies
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Emotion Regulation
Keywords: emotion
emotion regulation
reappraisal
avoidance
children
adolescence
Lead sponsor: Miami University
Sponsor class: OTHER
Collaborators: name: University of California, Riverside
First posted: 2024-10-04
Enrollment: 204
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All children will experience brief standardized laboratory tasks according to the same protocol.
Primary purpose: BASIC_SCIENCE

Brief summary: This study will examine the relation between behavioral emotion regulation (ER) strategies at toddler age 3 to cognitive ER strategies in early adolescence as part of an ongoing longitudinal study of children\&amp;#39;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 10-14 years old. In a completed wave of data collection, children\&amp;#39;s ER behaviors were elicited in laboratory tasks characterized by threat (novelty and uncertainty) at age 3. Avoidant and engaged cognitive ER strategies will be assessed by youth self-report, parent-report, and interviews with youth after they engage in new laboratory tasks characterized by mild threat. Hypothesis 1a: Self-soothing/caregiver-focused toddler behavioral ER strategies will predict avoidant cognitive strategies in early adolescence. Hypothesis 1b: The toddler behavioral ER strategy of distraction will predict engaged cognitive ER strategies in early adolescence. To provide additional developmental information, Aim 2 is to test whether child age at the follow up assessment (ranging 10-14 years) moderates the relation between behavioral ER strategies at age 3 and cognitive emotion regulatory strategies in early 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., inhibited/fearful 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 early adolescence. The investigators expect inhibited/fearful temperament to be involved in the link between behavioral ER strategies and avoidant cognitive ER strategies. The investigators expect the emotional family environment to be involved in linking behavioral ER strategies to both avoidant and engaged ER strategies.

Detailed description: Children (10 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\&#39;s self-reported avoidant and engaged cognitive ER strategies, worded with third or first person, respectively. \&#34;Short form\&#34; 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\&#39;s Response Styles Questionnaire provides a 5 item scale of problem-solving (also, \&#34;reflection\&#34;) and a 5 item scale of rumination (also, \&#34;brooding\&#34;). Mothers will complete the Children\&#39;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 \&#34;in-vivo\&#34; 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 \&#34;Storytelling\&#34; 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 \&#34;Mask\&#34; 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\&#39;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.

Eligibility criteria: 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.

Primary outcomes:
measure: Emotion Regulation Questionnaire for Children and Adolescents
timeFrame: 3 minutes (at 1.5 hour laboratory visit)
measure: Avoidance and Fusion Questionnaire for Youth-Short Form
timeFrame: 2 minutes (at 1.5 hour laboratory visit)
measure: Children&#39;s Response Styles Questionnaire
timeFrame: 2 minutes (at 1.5 hour laboratory visit)
measure: Avoidant emotion regulation strategies to threat
timeFrame: 1.5 hours (at laboratory visit)
measure: Engaged emotion regulation strategies
timeFrame: 1.5 hours (at laboratory visit)
Secondary outcomes:
measure: Electrocardiogram
timeFrame: 1.5 hours over the course of laboratory visit
measure: Children&amp;#39;s Responses to Feelings Checklist
timeFrame: 1.5 hours (at laboratory visit)
Other outcomes:
Locations:
city: Oxford
country: United States
facility: Miami University Department of Psychology
state: Ohio
Study officials:
affiliation: Miami University
name: Elizabeth J Kiel Luebbe, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: