Trial Outcomes & Findings for Tantrum Tamers 2.0: The Role of Emotion (NCT NCT03597789)

Last Updated: 2021-09-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

45 participants

Primary outcome timeframe

Baseline, study completion, approximately 10 weeks total

Results posted on

2021-09-16

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	45
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	35

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tantrum Tamers 2.0: The Role of Emotion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Helping the NonCompliant Child Treatment n=45 Participants 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.
Age, Continuous	4.83 years STANDARD_DEVIATION 1.15 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	45 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	36 Participants n=5 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	45 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, study completion, approximately 10 weeks total

Outcome measures

Outcome measures
Measure	Helping the NonCompliant Child Treatment n=35 Participants 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.
Change in Eyberg Child Behavior Inventory (ECBI) Score-Intensity	-45.46 score on a scale Interval -101.0 to -4.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Helping the NonCompliant Child Treatment n=35 Participants 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.
Change in Eyberg Child Behavior Inventory (ECBI) Score-Problem	-9.37 score on a scale Interval -24.0 to 4.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Helping the NonCompliant Child Treatment n=35 Participants 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.
Change in Difficulties With Emotion Regulation Scale (DERS) Score	-1.11 score on a scale Interval -39.0 to 82.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Helping the NonCompliant Child Treatment n=35 Participants 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.
Change in Coping With Children's Negative Emotions Scale Score Supportive	0.45 score on a scale Interval -2.08 to 1.67
Change in Coping With Children's Negative Emotions Scale Score Non-Supportive	-1.06 score on a scale Interval -5.11 to 1.08

Adverse Events

Helping the NonCompliant Child Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Deborah Jones, PhD

University of North Carolina at Chapel Hill

Phone: 919-962-5082

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place