Clinical trial NCT02794051: Transdiagnostic Group Intervention for Children With Behavior Problems
Official title: Implementation of a Transdiagnostic Group Intervention for Children With Behavior Problems Within a Pediatric Outpatient Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavioral Symptoms
Emotional Disturbances
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Children's Hospital Colorado
First posted: 2016-06-08
Enrollment: 8
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study fills a notable gap in the transdiagnostic literature by evaluating whether an evidence-based transdiagnostic treatment for emotional disorders such as the Unified Protocol for Children (UP-C) is effective for treating childhood behavior problems.

Detailed description: By participating in the study, child participants will learn emotion regulation skills and have opportunities to interact and practice skills with other children who have similar problems. In addition, parent participants will learn effective parenting skills, including appropriate limit-setting, use of praise and consequences, and empathy, that may help them effectively navigate the challenges of caring for a child with behavior concerns (1). Parents will also have the opportunity to interact with other parents who face similar challenges, providing validation and support. Upon completion of the study, investigators plan to share these findings at professional conferences and submit manuscripts to peer-reviewed journals. Collectively, this study will add to the literature in the pediatric mental health field and may also serve as a model for other outpatient clinics regarding implementation and provision of a transdiagnostic approach to treat children with behavior problems. Thus, the main goals of the current study are to examine the effectiveness of the UP-C group treatment in reducing childhood behavior problems, evaluate parents' satisfaction with this treatment, and determine the feasibility of implementing this treatment in a pediatric outpatient setting.

Eligibility criteria: Inclusion Criteria:

* Ages 8 - 12 years
* English speaking
* Primary Behavior Disorder
* At least 1 English-speaking parent/legal guardian who can provide informed consent for the child
* Parent/Legal Guardian must agree to participate in the Trial

Exclusion Criteria:

* Child is: a ward of the state
* has active suicidal ideation
* has homicidal ideation
* has self-harm behaviors
* has an intellectual disability
* has a pervasive developmental disability or significant developmental delay
* has an active substance use disorder
* is currently participating in individual or group psychotherapy, or
* has participated in therapy within the past year
* has a sibling that is also enrolled in the study
* Parents/Legal Guardians that:

  1. are unwilling to participate in the study
  2. are non-English speaking
  3. have an intellectual disability
  4. have a pervasive developmental disability or
  5. a significant developmental delay
  6. do not have legal custody of the child participant
  7. do not reside in the same home as the child participant

Primary outcomes:
measure: Change in rates of noncompliance, tantruming, and parenting practices on the Home Record Card
timeFrame: 12 weeks - Measured daily from baseline to post-treatment
Secondary outcomes:
measure: Change in pre- vs. post-treatment scores on the Transdiagnostic Questionnaires for Parent and Child
timeFrame: 10 weeks - Measured at Week 1 (pre-treatment) and at Week 10 (post-treatment)
measure: Change in pre- vs. post-treatment scores on the Eyberg Child Behavior Inventory
timeFrame: 10 weeks - Measured at Week 1 (pre-treatment) and at Week 10 (post-treatment)
measure: Change in pre- vs. post-treatment scores on the Achenbach Rating Scales (Child Behavior Checklist and Youth Self-Report)
timeFrame: 10 weeks - Measured at Week 1 (pre-treatment) and at Week 10 (post-treatment)
measure: Change in pre- vs. post-treatment scores on the Alabama Parenting Questionnaire
timeFrame: 10 weeks - Measured at Week 1 (pre-treatment) and at Week 10 (post-treatment)
measure: Parents' satisfaction with treatment, as measured by the Family Satisfaction Survey
timeFrame: 10 weeks - Measured at weeks 3, 7, and 10.
measure: Treatment feasibility, as measured by the Family Satisfaction Survey and attendance rates
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Jessica Malmberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ehrenreich-May et al., 2012