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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21MH113887-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Helping the Noncompliant Child (HNC) | Behavioral | HNC is a mastery-based, family-focused, clinic-based treatment for young children aged 3-8 years with problem behavior. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline, study completion, approximately 10 weeks total |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deborah Jones, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Department of Psychology & Neuroscience | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36385585 | Derived | 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. | |
| 34533656 | Derived | 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. |
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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.
9 to 36 months following publication of primary study results
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| ID | Title | Description |
|---|---|---|
| FG000 | Helping the NonCompliant Child Treatment | Families will participate in approximately 10 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Helping the NonCompliant Child Treatment | Families will participate in approximately 10 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Full Range | score on a scale | Baseline, study completion, approximately 10 weeks total |
|
From the time of Informed Consent through post assessment visit, an approximate total of 10 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Helping the NonCompliant Child Treatment | Families will participate in approximately 10 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deborah Jones, PhD | University of North Carolina at Chapel Hill | 919-962-5082 | djjones@email.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 24, 2021 | Jul 19, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002652 | Child Behavior |
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D000066553 | Problem Behavior |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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All families get the evidence-based treatment, Helping the Noncompliant Child (HNC)
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| 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. | Baseline, study completion, approximately 10 weeks total |
| 34378434 | Derived | 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. |
| 33900099 | Derived | 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. |
| 33622517 | Derived | 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. |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Primary | 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. | Posted | Mean | Full Range | score on a scale | Baseline, study completion, approximately 10 weeks total |
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|
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| Secondary | 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. | Posted | Mean | Full Range | score on a scale | Baseline, study completion, approximately 10 weeks total |
|
|
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| Secondary | 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. | Posted | Mean | Full Range | score on a scale | Baseline, study completion, approximately 10 weeks total |
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| 0 |
| 45 |
| 0 |
| 45 |
| 0 |
| 45 |
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| D010342 |
| Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |