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— Status: Withdrawn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Withdrawn |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.