NCT06627777

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'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 10-15 years old. In a completed wave of data collection, children'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 10-15 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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Progress89%
Oct 2023Sep 2026

Study Start

First participant enrolled

October 23, 2023

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

July 29, 2025

Status Verified

July 1, 2025

Enrollment Period

2.9 years

First QC Date

October 2, 2024

Last Update Submit

July 24, 2025

Conditions

Keywords

emotionemotion regulationreappraisalavoidancechildrenadolescence

Outcome Measures

Primary Outcomes (5)

  • 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)

  • Avoidant emotion regulation strategies to threat

    Interview responses regarding use of expressive suppression, experiential avoidance, and rumination/brooding strategies

    1.5 hours (at laboratory visit)

  • Engaged emotion regulation strategies

    Interview responses regarding use of reappraisal and problem-solving/reflection strategies

    1.5 hours (at laboratory visit)

Secondary Outcomes (2)

  • Electrocardiogram

    1.5 hours over the course of laboratory visit

  • Children's Responses to Feelings Checklist

    1.5 hours (at laboratory visit)

Study Arms (1)

Emotion regulation observation in early adolescence

OTHER

All children will experience brief standardized laboratory tasks according to the same protocol.

Behavioral: Laboratory tasks in early 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 early adolescence

Eligibility Criteria

Age10 Years - 15 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 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.

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

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

October 2, 2024

First Posted

October 4, 2024

Study Start

October 23, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

July 29, 2025

Record last verified: 2025-07

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