N/A
N=48
Behavioral Treatment for Children With Conduct Problems and Callous-Unemotional Traits
Conduct Disorder · Oppositional Defiant Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01362946 ↗Enrolled (actual)
48
Serious AEs
—
Results posted
Jan 2016
Primary outcome: Primary: Conduct Problems — 0.76; 1.08; 0.41; 0.92 Number of conduct problems per day
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Reward-Emphasized Treatment (Behavioral); Standard Treatment (Behavioral)
- Age
- Pediatric · 7+ yrs
- Sex
- All
- Sponsor
- Florida International University
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Conduct Problems |
0.76; 1.08; 0.41; 0.92; 0.76; 1.26 | — |
| PRIMARY Negative Verbalizations |
5.70; 7.32; 6.73; 5.91; 4.94; 9.16 | — |
| PRIMARY Complaining |
5.25; 4.92; 2.76; 3.54; 3.33; 5.18 | — |
| PRIMARY Interruption |
9.86; 14.81; 13.43; 12.61; 10.21; 14.32 | — |
| PRIMARY Noncompliance |
3.82; 4.29; 3.52; 2.99; 3.35; 5.16 | — |
| PRIMARY Rule Violations |
36.65; 40.84; 33.93; 35.31; 27.28; 41.89 | — |
| PRIMARY Positive Peer Behavior |
4.91; 4.51; 4.84; 4.33; 5.42; 7.08 | — |
| PRIMARY Minutes in Time Out |
10.62; 14.77; 9.50; 10.17; 6.57; 12.15 | — |
| PRIMARY Number of Time Outs |
0.69; 1.00; 1.15; 0.76; 0.82; 1.09 | — |
| PRIMARY Minutes of Physical Management |
0.09; 0.21; 0.29; 0.31; 0.54; 0.30 | — |
| SECONDARY IOWA Inattentive/Overactive Scale - Counselor |
5.36; 5.57; 6.15; 5.78; 5.51; 5.59 | — |
| SECONDARY IOWA Inattentive/Overactive Scale - Parent |
6.71; 7.11; 6.88; 6.10; 6.15; 6.38 | — |
| SECONDARY IOWA Oppositional-defiant Scale - Counselor |
4.55; 4.99; 4.47; 4.85; 4.20; 5.01 | — |
| SECONDARY IOWA Oppositional-defiant Scale - Parent |
6.71; 6.99; 6.50; 6.15; 5.75; 5.80 | — |
| SECONDARY WPRF Serious Conduct Problems Scale - Counselor |
1.71; 1.81; 1.69; 1.70; 1.66; 1.83 | — |
| SECONDARY WPRF Serious Conduct Problems Scale - Parent |
2.47; 2.48; 2.22; 1.96; 2.05; 1.94 | — |
| SECONDARY WPRF Rule Following Problems - Counselor |
2.07; 2.18; 2.17; 2.19; 2.10; 2.17 | — |
| SECONDARY WPRF Rule Following Problems - Parent |
3.63; 3.88; 3.37; 3.47; 3.35; 3.31 | — |
| SECONDARY WPRF Overall Problems - Counselor |
3.42; 3.66; 3.49; 3.46; 3.36; 3.38 | — |
| SECONDARY WPRF Overall Problems - Parent |
3.68; 3.98; 3.57; 3.42; 3.65; 3.62 | — |
| SECONDARY How Much Did Your Child Benefit From Treatment? |
2.31; 2.45 | — |
| SECONDARY How Much Did You (the Parent) Benefit From Treatment? |
2.36; 2.40 | — |
| SECONDARY How Much Did Your Child Enjoy the Treatment? |
1.89; 2.12 | — |
| SECONDARY Would You Send Your Child to This Treatment Again? |
3.83; 3.83 | — |
| SECONDARY Recommend Treatment? |
3.90; 3.97 | — |
| SECONDARY Overall Satisfaction |
3.75; 3.83 | — |
| SECONDARY Overall Effectiveness |
3.66; 3.60 | — |
| SECONDARY Overall Treatment Recommendation - Counselor |
34; 27; 23; 16 | — |
| SECONDARY Overall Treatment Recommendation - Parent |
41; 59 | — |
Summary
The purpose of this study is to modify behavior therapy so that it is optimized for children with conduct problems and callous-unemotional traits by emphasizing reward components and de-emphasizing punishment components.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of oppositional defiant disorder or conduct disorder
- Ages 7 to 12 years old
- t-score of 65 or above on CU scale of Antisocial Process Screening Device as rated by parents or teacher
- at least parent/caregiver fluent in English
- able to participate in vigorous outdoor activities
- parent/caregiver agreement to keep psychoactive medication treatment constant throughout the study
Exclusion Criteria
- Full scale intelligence quotient (IQ) of less than 75
- medical conditions that contra-indicate participation in treatment
- current or past clinical diagnosis of pervasive developmental disorder, schizophrenia or other psychotic disorders, sexual disorder, organic mental disorder, or eating disorder
- lack of functional impairment
- current or past seizures or other neurological disorders
Data sourced from ClinicalTrials.gov (NCT01362946). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.