Adults 3 to 8, any sex, with Child Behavior or Attention Deficit and Disruptive Behavior Disorders. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Eyberg Child Behavior Inventory (ECBI) Score-IntensityPrimary· 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.
Group
Value
95% CI
Helping the NonCompliant Child Treatment
-45.46
-101.0 – -4.0
Change in Eyberg Child Behavior Inventory (ECBI) Score-ProblemPrimary· 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
Group
Value
95% CI
Helping the NonCompliant Child Treatment
-9.37
-24.0 – 4.0
Change in Difficulties With Emotion Regulation Scale (DERS) ScoreSecondary· 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 emotion
Group
Value
95% CI
Helping the NonCompliant Child Treatment
-1.11
-39.0 – 82.0
Change in Coping With Children's Negative Emotions Scale ScoreSecondary· 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
Supportive
Group
Value
95% CI
Helping the NonCompliant Child Treatment
0.45
-2.08 – 1.67
Non-Supportive
Group
Value
95% CI
Helping the NonCompliant Child Treatment
-1.06
-5.11 – 1.08
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of North Carolina, Chapel Hill
Last refreshed: 16 September 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03597789.