NCT05415319

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 13, 2022

Completed
1.1 years until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

1.3 years

First QC Date

June 8, 2022

Last Update Submit

November 16, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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)

  • 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)

  • 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 Outcomes (2)

  • Electrocardiogram

    1.5 hours over the course of laboratory visit

  • Children's Responses to Feelings Checklist

    2 minutes (at 1.5 hour laboratory visit)

Study Arms (1)

Emotion regulation observation in middle childhood/pre-adolescence

OTHER

All participants will engage in brief laboratory tasks that are designed to elicit a brief experience of emotion/uncertainty.

Behavioral: Laboratory tasks in middle childhood/pre-adolescence

Interventions

Children will watch a 2-minute clip from a live-action movie and complete Storytelling and Mask tasks from the Laboratory Temperament Assessment Battery.

Emotion regulation observation in middle childhood/pre-adolescence

Eligibility Criteria

Age8 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Informed consent/assent is declined
  • Child diagnosed with a developmental disability or chronic health condition related to deviations in expected emotional development.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Miami University Department of Psychology

Oxford, Ohio, 45056, United States

Location

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Study Officials

  • Elizabeth J. Kiel Luebbe, Ph.D.

    Miami University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: All children will experience brief standardized laboratory tasks according to the same protocol.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2022

First Posted

June 13, 2022

Study Start

August 1, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

De-identified and processed data will be posted to Open Science Framework. No identifying information will be shared. Final version of data (e.g., behavioral coding composites, survey scores) reported in manuscripts will be shared.

Shared Documents
SAP, ANALYTIC CODE
Time Frame
Data will be posted towards the end of the grant period (months 21-24), should funding be received. Data will be available indefinitely.
Access Criteria
Academic affiliation

Locations