Child BehaviorNCT03597789

Tantrum Tamers 2.0: The Role of Emotion

A study testing Helping the Noncompliant Child (HNC) in people with Child Behavior and Attention Deficit and Disruptive Behavior Disorders, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study aims to better understand how to best help parents of young children with problem behavior. Problem behaviors vary between and within children, but can include inattention/hyperactivity, tantrums, and/or noncompliance. Read more about this study

Who is it for?: Ages 3 to 8 yearsHealthy volunteers can take part
Conditions the study is for: Child Behavior, Attention Deficit and Disruptive Behavior Disorders, Problem Behavior
What is being tested?: Helping the Noncompliant Child (HNC)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 1 siteUnited States
Study dates: 1 Nov 2018to 2 Nov 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 3 to 8 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Clinically significant child problem behavior

Who cannot join

Current severe symptoms in parent or child that would prohibit participation (e.g., parent current psychotic or substance use disorder)

Trial locations and contacts

1 site in 1 country.

United States1 site

UNC Department of Psychology & Neuroscience
Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

Official title: The Role of Emotion Regulation and Socialization in Behavioral Parent Training (BPT) Efficiency and Outcomes

Read the detailed description

If eligible and choose to participate, this study includes:

A baseline assessment which will include asking a series of questions about parent, child and family, as well as parent-child observations.

If eligible for treatment, sessions occur once per week for approximately 8 to 12 weeks. Sessions include new information and lots of practice and discussion about how to make the skills work best for specific families.

After finishing treatment a post-assessment (similar to BL) conducted.

All of the assessments (i.e., video-and audio-recorded), as well as the sessions with a therapist will be recorded (i.e., video recorded).

Conditions: Child Behavior, Attention Deficit and Disruptive Behavior Disorders, Problem Behavior
Being tested: Helping the Noncompliant Child (HNC)
Keywords: Tantrums, Inattentive, Noncompliance
Medical subject headings: Child Behavior, Attention Deficit and Disruptive Behavior Disorders, Problem Behavior, Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Helping the Noncompliant Child (HNC)Behavioural
HNC is a mastery-based, family-focused, clinic-based treatment for young children aged 3-8 years with problem behavior.

Study groups in NCT03597789
Study group	Role	What they receive
Helping the NonCompliant Child Treatment	Other	Families will participate in an average of 8 to 12 weeks of Behavioral Parent Training (BPT), by way of the standard-of-care training program "Helping the Noncompliant Child" (HNC) via weekly sessions and mid-week calls. Receives: Behavioral: Helping the Noncompliant Child (HNC)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Eyberg Child Behavior Inventory (ECBI) Score-Intensity
The ECBI is a 36 item parent-report scale. For each item, parents rate the intensity of the behavior (0 = never to 7 = always) and whether they consider each behavior to be a problem (0 = no; 1 = yes). Clinically significant symptoms are defined by scores more than 2 standard deviations above the normed mean for the Intensity Subscale (clinical cutoff = 127) and/or Problem Subscale (clinical cutoff = 11) Scales. Intensity scores range from 36 to 252. A mean score decrease indicates a reduction in parent perception of the intensity of the problem behavior.
Measured: Baseline, study completion, approximately 10 weeks total
Change in Eyberg Child Behavior Inventory (ECBI) Score-Problem
The ECBI is a 36 item parent-report scale. For each item, parents rate the intensity of the behavior (0 = never to 7 = always) and whether they consider each behavior to be a problem (0 = no; 1 = yes). Clinically significant symptoms are defined by scores more than 2 standard deviations above the normed mean for the Intensity Subscale (clinical cutoff = 127) and/or Problem Subscale (clinical cutoff = 11) Scales. The number of "yes" responses are counted and averaged. Problem scores range from 0 to 36. A mean score decrease indicates a reduction in parent perception of the number of the problem behaviors.
Measured: Baseline, study completion, approximately 10 weeks total

Secondary outcomes (2)

Change in Difficulties With Emotion Regulation Scale (DERS) Score
The Difficulties in Emotion Regulation Scale (DERS) will be used as the measure of caregiver's emotion dysregulation. The 36-item DERS yields a composite total score as well as scores for the following subscales: 1) Nonacceptance Subscale, non-acceptance of negative emotions; 2) Goal Subscale, difficulties in engaging in goal-directed behaviors when experiencing negative emotions, 3) Impulse Subscale, impulse control difficulties; 4) Strategies Subscale, limited access to emotion regulation strategies; 5) Awareness Subscale, lack of emotional awareness; and 6) Clarity Subscale, lack of emotional clarity. DERS total scores range from 36 to 180. The composite total is reported for this small sample size. A mean score decrease indicates a reduction in parent difficulties with emotion regulation.
Measured: Baseline, study completion, approximately 10 weeks total
Change in Coping With Children's Negative Emotions Scale Score
The Coping with Children's Negative Emotions Scale (CCNES) assesses the ways that parents cope with their children's distress and negative emotions. Participants use a 7-point Likert scale where 7 indicates high levels of specific parenting behavior (i.e. supportive and non-supportive parenting behavior). Scores are reported condensing 6 categories into 2 broader domains (supportive/non-supportive) with scores ranging from 1 to 21. Assessed at Baseline and end of study. A mean score decrease in non-supportive scores reflects an improvement in parents' non-supportive strategies and a mean score increase in the supportive score indicates improvement in parents' supportive strategies.
Measured: Baseline, study completion, approximately 10 weeks total

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 20182 Nov 2020

First posted24 Jul 2018
Study start1 Nov 2018
Primary completion2 Nov 2020
Study completion2 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Child BehaviorStudies of the same condition, open and under way.
More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
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: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: All families get the evidence-based treatment, Helping the Noncompliant Child (HNC)
Masking: None (open label)
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03597789
Sponsor's protocol ID: 18-1040
Other IDs: 1R21MH113887-01A1
Status last verified: Jul 2021
First submitted: 29 Jun 2018
Last updated: 16 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB) and executes a data use/sharing agreement with UNC.

Publications

McKee LG, Yang Y, Highlander A, McCall M, Jones DJ. Conceptualizing the Role of Parent and Child Emotion Regulation in the Treatment of Early-Onset Behavior Disorders: Theory, Research, and Future Directions. Clin Child Fam Psychol Rev. 2023 Mar;26(1):272-301. doi: 10.1007/s10567-022-00419-y. Epub 2022 Nov 17.
PubMed 36385585
Highlander AR, Jones DJ. Integrating Objective and Subjective Social Class to Advance Our Understanding of Externalizing Problem Behavior in Children and Adolescents: A Conceptual Review and Model. Clin Child Fam Psychol Rev. 2022 Jun;25(2):300-315. doi: 10.1007/s10567-021-00369-x. Epub 2021 Sep 17.
PubMed 34533656
Highlander A, Zachary C, Jenkins K, Loiselle R, McCall M, Youngstrom J, McKee LG, Forehand R, Jones DJ. Clinical Presentation and Treatment of Early-Onset Behavior Disorders: The Role of Parent Emotion Regulation, Emotion Socialization, and Family Income. Behav Modif. 2022 Sep;46(5):1047-1074. doi: 10.1177/01454455211036001. Epub 2021 Aug 11.
PubMed 34378434
Loiselle R, Parent J, Georgeson AR, Thissen D, Jones DJ, Forehand R. Validation of the Multidimensional Assessment of Parenting: An application of item response theory. Psychol Assess. 2021 Sep;33(9):803-815. doi: 10.1037/pas0001019. Epub 2021 Apr 26.
PubMed 33900099
Jones DJ, Loiselle R, Zachary C, Georgeson AR, Highlander A, Turner P, Youngstrom JK, Khavjou O, Anton MT, Gonzalez M, Bresland NL, Forehand R. Optimizing Engagement in Behavioral Parent Training: Progress Toward a Technology-Enhanced Treatment Model. Behav Ther. 2021 Mar;52(2):508-521. doi: 10.1016/j.beth.2020.07.001. Epub 2020 Jul 15.
PubMed 33622517

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Child Behavior trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Role of Emotion Regulation and Socialization in Behavioral Parent Training (BPT) Efficiency and Outcomes
ClinicalTrials.gov ID: NCT03597789
Acronym / sponsor ID: 18-1040
Conditions: Child Behavior, Attention Deficit and Disruptive Behavior Disorders, Problem Behavior
Keywords: Tantrums, Inattentive, Noncompliance
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 1 Nov 2018 (actual)
Primary completion: 2 Nov 2020 (actual)
Study completion: 2 Nov 2020 (actual)
First posted: 24 Jul 2018 (actual)
Results: Posted 16 Aug 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

If eligible and choose to participate, this study includes:

A baseline assessment which will include asking a series of questions about parent, child and family, as well as parent-child observations.

After finishing treatment a post-assessment (similar to BL) conducted.

All of the assessments (i.e., video-and audio-recorded), as well as the sessions with a therapist will be recorded (i.e., video recorded).

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: All families get the evidence-based treatment, Helping the Noncompliant Child (HNC)

Arm	Type	Receives
Helping the NonCompliant Child Treatment	Other	Behavioral: Helping the Noncompliant Child (HNC)Families will participate in an average of 8 to 12 weeks of Behavioral Parent Training (BPT), by way of the standard-of-care training program "Helping the Noncompliant Child" (HNC) via weekly sessions and mid-week calls.

Who may qualify

Ages: 3 to 8 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (1 listed)

Clinically significant child problem behavior

Key exclusion criteria (1 listed)

Current severe symptoms in parent or child that would prohibit participation (e.g., parent current psychotic or substance use disorder)

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
Helping the Noncompliant Child (HNC)HNC is a mastery-based, family-focused, clinic-based treatment for young children aged 3-8 years with problem behavior.	Behavioural	Helping the NonCompliant Child Treatment

Primary outcome

Change in Eyberg Child Behavior Inventory (ECBI) Score-Intensity
Time frame: Baseline, study completion, approximately 10 weeks total
The ECBI is a 36 item parent-report scale. For each item, parents rate the intensity of the behavior (0 = never to 7 = always) and whether they consider each behavior to be a problem (0 = no; 1 = yes). Clinically significant symptoms are defined by scores more than 2 standard deviations above the normed mean for the Intensity Subscale (clinical cutoff = 127) and/or Problem Subscale (clinical cutoff = 11) Scales. Intensity scores range from 36 to 252. A mean score decrease indicates a reduction in parent perception of the intensity of the problem behavior.
Change in Eyberg Child Behavior Inventory (ECBI) Score-Problem
Time frame: Baseline, study completion, approximately 10 weeks total
The ECBI is a 36 item parent-report scale. For each item, parents rate the intensity of the behavior (0 = never to 7 = always) and whether they consider each behavior to be a problem (0 = no; 1 = yes). Clinically significant symptoms are defined by scores more than 2 standard deviations above the normed mean for the Intensity Subscale (clinical cutoff = 127) and/or Problem Subscale (clinical cutoff = 11) Scales. The number of "yes" responses are counted and averaged. Problem scores range from 0 to 36. A mean score decrease indicates a reduction in parent perception of the number of the problem behaviors.

2 secondary outcomes

Change in Difficulties With Emotion Regulation Scale (DERS) Score
Time frame: Baseline, study completion, approximately 10 weeks total
Change in Coping With Children's Negative Emotions Scale Score
Time frame: Baseline, study completion, approximately 10 weeks total

Results and safety

Results posted to the registry on 16 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Helping the NonCompliant Child Treatment	45	10

Primary outcome: Change in Eyberg Child Behavior Inventory (ECBI) Score-Intensity

Time frame: Baseline, study completion, approximately 10 weeks total. Mean (Full Range). Unit: score on a scale

Measure	Helping the NonCompliant Child Treatment n = 35
Value	-45.46 (-101.0 to -4.0)

Primary outcome: Change in Eyberg Child Behavior Inventory (ECBI) Score-Problem

Time frame: Baseline, study completion, approximately 10 weeks total. Mean (Full Range). Unit: score on a scale

Measure	Helping the NonCompliant Child Treatment n = 35
Value	-9.37 (-24.0 to 4.0)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the time of Informed Consent through post assessment visit, an approximate total of 10 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Helping the NonCompliant Child Treatment	0 of 45 (0%)	0 of 45 (0%)	0 of 45

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36385585McKee LG, Yang Y, Highlander A, McCall M, Jones DJ. Conceptualizing the Role of Parent and Child Emotion Regulation in the Treatment of Early-Onset Behavior Disorders: Theory, Research, and Future Directions. Clin Child Fam Psychol Rev. 2023 Mar;26(1):272-301. doi: 10.1007/s10567-022-00419-y. Epub 2022 Nov 17.
Derived from this study: PubMed 34533656Highlander AR, Jones DJ. Integrating Objective and Subjective Social Class to Advance Our Understanding of Externalizing Problem Behavior in Children and Adolescents: A Conceptual Review and Model. Clin Child Fam Psychol Rev. 2022 Jun;25(2):300-315. doi: 10.1007/s10567-021-00369-x. Epub 2021 Sep 17.
Derived from this study: PubMed 34378434Highlander A, Zachary C, Jenkins K, Loiselle R, McCall M, Youngstrom J, McKee LG, Forehand R, Jones DJ. Clinical Presentation and Treatment of Early-Onset Behavior Disorders: The Role of Parent Emotion Regulation, Emotion Socialization, and Family Income. Behav Modif. 2022 Sep;46(5):1047-1074. doi: 10.1177/01454455211036001. Epub 2021 Aug 11.
Derived from this study: PubMed 33900099Loiselle R, Parent J, Georgeson AR, Thissen D, Jones DJ, Forehand R. Validation of the Multidimensional Assessment of Parenting: An application of item response theory. Psychol Assess. 2021 Sep;33(9):803-815. doi: 10.1037/pas0001019. Epub 2021 Apr 26.
Derived from this study: PubMed 33622517Jones DJ, Loiselle R, Zachary C, Georgeson AR, Highlander A, Turner P, Youngstrom JK, Khavjou O, Anton MT, Gonzalez M, Bresland NL, Forehand R. Optimizing Engagement in Behavioral Parent Training: Progress Toward a Technology-Enhanced Treatment Model. Behav Ther. 2021 Mar;52(2):508-521. doi: 10.1016/j.beth.2020.07.001. Epub 2020 Jul 15.
Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB) and executes a data use/sharing agreement with UNC.

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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.

Deborah Jones, PhD principal investigator

University of North Carolina, Chapel Hill

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 1 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: finished, as of the sponsor's last update on 16 Sep 2021. 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?

Yes. Results are posted in the registry (first posted 16 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Eyberg Child Behavior Inventory (ECBI) Score-Intensity (time frame: Baseline, study completion, approximately 10 weeks total). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03597789, which also lists 5 linked publications.

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 16 Sep 2021.