Attention Deficit and Disruptive Behavior Disorders, Child Behavior, Problem Behavior
Conditions
Keywords
Tantrums, Inattentive, Noncompliance
Brief 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.
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).
Interventions
BEHAVIORALHelping the Noncompliant Child (HNC)
HNC is a mastery-based, family-focused, clinic-based treatment for young children aged 3-8 years with problem behavior.
Sponsors
National Institute of Mental Health (NIMH)
University of North Carolina, Chapel Hill
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All families get the evidence-based treatment, Helping the Noncompliant Child (HNC)
Eligibility
Sex/Gender
ALL
Age
3 Years to 8 Years
Healthy volunteers
Yes
Inclusion criteria
* Clinically significant child problem behavior
Exclusion criteria
* Current severe symptoms in parent or child that would prohibit participation (e.g., parent current psychotic or substance use disorder)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Eyberg Child Behavior Inventory (ECBI) Score-Intensity | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Difficulties With Emotion Regulation Scale (DERS) Score | Baseline, study completion, approximately 10 weeks total | 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. |
| Change in Coping With Children's Negative Emotions Scale Score | Baseline, study completion, approximately 10 weeks total | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 45 |
| Total | 45 |
Baseline characteristics
| Characteristic | Helping the NonCompliant Child Treatment |
|---|---|
| Age, Continuous | 4.83 years STANDARD_DEVIATION 1.15 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 45 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 36 Participants |
| Region of Enrollment United States | 45 Participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 45 |
| other Total, other adverse events | 0 / 45 |
| serious Total, serious adverse events | 0 / 45 |
Outcome results
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.
Time frame: Baseline, study completion, approximately 10 weeks total
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Helping the NonCompliant Child Treatment | Change in Eyberg Child Behavior Inventory (ECBI) Score-Intensity | -45.46 score on a scale |
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.
Time frame: Baseline, study completion, approximately 10 weeks total
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Helping the NonCompliant Child Treatment | Change in Eyberg Child Behavior Inventory (ECBI) Score-Problem | -9.37 score on a scale |
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.
Time frame: Baseline, study completion, approximately 10 weeks total
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Helping the NonCompliant Child Treatment | Change in Coping With Children's Negative Emotions Scale Score | Supportive | 0.45 score on a scale |
| Helping the NonCompliant Child Treatment | Change in Coping With Children's Negative Emotions Scale Score | Non-Supportive | -1.06 score on a scale |
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.
Time frame: Baseline, study completion, approximately 10 weeks total
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Helping the NonCompliant Child Treatment | Change in Difficulties With Emotion Regulation Scale (DERS) Score | -1.11 score on a scale |