Emotion RegulationNCT05415319
Emotion Regulation Strategies in Toddlerhood and Middle Childhood
A study testing Laboratory tasks in middle childhood/pre-adolescence in people with Emotion Regulation, run by Miami University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotion Regulation
- What is being tested?
- Laboratory tasks in middle childhood/pre-adolescence
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Informed consent/assent is declined
- Child diagnosed with a developmental disability or chronic health condition related to deviations in expected emotional development.
Trial locations and contacts
1 site in 1 country.
United States1 site
Miami University Department of Psychology
Oxford, Ohio, 45056
About this study
Official title: Relation of Emotion Regulatory Behaviors in Early Childhood to Cognitive Emotion Regulation Strategies in Middle Childhood and Pre-Adolescence
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.
Read the detailed 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.
- Conditions
- Emotion Regulation
- Being tested
- Laboratory tasks in middle childhood/pre-adolescence
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory tasks in middle childhood/pre-adolescenceBehavioural
Children will watch a 2-minute clip from a live-action movie and complete Storytelling and Mask tasks from the Laboratory Temperament Assessment Battery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Laboratory tasks in middle childhood/pre-adolescence |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 2 minutes (at 1.5 hour laboratory visit)
Secondary outcomes (2)
Electrocardiogram
Respiratory sinus arrhythmia (RSA) will be derived as a metric of variance in interbeat intervals at rate of respiration, exhibited during laboratory tasks
Measured: 1.5 hours over the course of laboratory visit
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)
Measured: 2 minutes (at 1.5 hour laboratory visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study startAug 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: Not funded.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotion RegulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All children will experience brief standardized laboratory tasks according to the same protocol.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miami University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Riverside
- Responsible party
- Sponsor
- Investigators
- Elizabeth J. Kiel Luebbe, Ph.D., Principal investigator, Miami University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415319
- Sponsor's protocol ID
- KielR032022
- Status last verified
- Nov 2023
- First submitted
- 8 Jun 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation of Emotion Regulatory Behaviors in Early Childhood to Cognitive Emotion Regulation Strategies in Middle Childhood and Pre-Adolescence
- ClinicalTrials.gov ID
- NCT05415319
- Acronym / sponsor ID
- KielR032022
- Conditions
- Emotion Regulation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not funded.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Miami UniversityUniversity, hospital or other
- Collaborators
- University of California, Riverside
- Study start
- Aug 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 13 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All children will experience brief standardized laboratory tasks according to the same protocol.
| Arm | Type | Receives |
|---|---|---|
| Emotion regulation observation in middle childhood/pre-adolescence | Other | Behavioral: Laboratory tasks in middle childhood/pre-adolescenceAll participants will engage in brief laboratory tasks that are designed to elicit a brief experience of emotion/uncertainty. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Informed consent/assent is declined
- Child diagnosed with a developmental disability or chronic health condition related to deviations in expected emotional development.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory tasks in middle childhood/pre-adolescenceChildren will watch a 2-minute clip from a live-action movie and complete Storytelling and Mask tasks from the Laboratory Temperament Assessment Battery. | Behavioural | Emotion regulation observation in middle childhood/pre-adolescence |
Primary outcome
Emotion Regulation Questionnaire for Children and Adolescents
Time frame: 3 minutes (at 1.5 hour laboratory visit)
Parent- and child self-report versions of this survey measure, including 6-item Reappraisal subscale and 4-item Expressive Suppression subscale
Avoidance and Fusion Questionnaire for Youth-Short Form
Time frame: 2 minutes (at 1.5 hour laboratory visit)
Parent- and child self-report versions of this survey measure, which provides an 8-item subscale of Experiential Avoidance
Children's Response Styles Questionnaire
Time frame: 2 minutes (at 1.5 hour laboratory visit)
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 secondary outcomes
Electrocardiogram
Time frame: 1.5 hours over the course of laboratory visit
Children's Responses to Feelings Checklist
Time frame: 2 minutes (at 1.5 hour laboratory visit)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth J. Kiel Luebbe, Ph.D. principal investigator
Miami University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laboratory tasks in middle childhood/pre-adolescence in people with Emotion Regulation, run by Miami University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotion Regulation Questionnaire for Children and Adolescents (time frame: 3 minutes (at 1.5 hour laboratory visit)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.