Transdiagnostic Group Intervention for Children With Behavior Problems
Primary Purpose
Behavioral Symptoms, Emotional Disturbances
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Behavioral Symptoms
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:
- are unwilling to participate in the study
- are non-English speaking
- have an intellectual disability
- have a pervasive developmental disability or
- a significant developmental delay
- do not have legal custody of the child participant
- do not reside in the same home as the child participant
Sites / Locations
- Children's Hospital Colorado
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Unified Protocol for Children
Arm Description
Child participants with behavior problems between the ages of 8-12 and their caregivers will participate in a transdiagnostic group therapy protocol.
Outcomes
Primary Outcome Measures
Change in rates of noncompliance, tantruming, and parenting practices on the Home Record Card
Chart for recording events of noncompliance, tantrums, and parenting practices.
Secondary Outcome Measures
Change in pre- vs. post-treatment scores on the Transdiagnostic Questionnaires for Parent and Child
Measures several transdiagnostic mechanisms including child emotional and behavioral symptoms, sleeping difficulties, and parenting practices.
Change in pre- vs. post-treatment scores on the Eyberg Child Behavior Inventory
Measures intensity of behavior related problems and degree to which these behaviors are viewed as problematic by parents.
Change in pre- vs. post-treatment scores on the Achenbach Rating Scales (Child Behavior Checklist and Youth Self-Report)
Measures parent and child report of the presence of child behavior and emotional problems
Change in pre- vs. post-treatment scores on the Alabama Parenting Questionnaire
Measures five dimensions of parenting: positive involvement, supervision, positive discipline techniques, consistency in disciplining, and use of corporal punishment.
Parents' satisfaction with treatment, as measured by the Family Satisfaction Survey
To assess parents' satisfaction with their participation in the UP-C intervention.
Treatment feasibility, as measured by the Family Satisfaction Survey and attendance rates
To evaluate parents' opinions about whether participation in a 10-week therapy group treatment is feasible and whether the interventions taught are feasible.
Full Information
NCT ID
NCT02794051
First Posted
May 17, 2016
Last Updated
September 28, 2016
Sponsor
University of Colorado, Denver
Collaborators
Children's Hospital Colorado
1. Study Identification
Unique Protocol Identification Number
NCT02794051
Brief Title
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
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Children's Hospital Colorado
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavioral Symptoms, Emotional Disturbances
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Unified Protocol for Children
Arm Type
Experimental
Arm Description
Child participants with behavior problems between the ages of 8-12 and their caregivers will participate in a transdiagnostic group therapy protocol.
Intervention Type
Behavioral
Intervention Name(s)
Group Therapy
Intervention Description
Participating children and their caregivers will attend 90-minute weekly group therapy sessions for 10 consecutive weeks.
Primary Outcome Measure Information:
Title
Change in rates of noncompliance, tantruming, and parenting practices on the Home Record Card
Description
Chart for recording events of noncompliance, tantrums, and parenting practices.
Time Frame
12 weeks - Measured daily from baseline to post-treatment
Secondary Outcome Measure Information:
Title
Change in pre- vs. post-treatment scores on the Transdiagnostic Questionnaires for Parent and Child
Description
Measures several transdiagnostic mechanisms including child emotional and behavioral symptoms, sleeping difficulties, and parenting practices.
Time Frame
10 weeks - Measured at Week 1 (pre-treatment) and at Week 10 (post-treatment)
Title
Change in pre- vs. post-treatment scores on the Eyberg Child Behavior Inventory
Description
Measures intensity of behavior related problems and degree to which these behaviors are viewed as problematic by parents.
Time Frame
10 weeks - Measured at Week 1 (pre-treatment) and at Week 10 (post-treatment)
Title
Change in pre- vs. post-treatment scores on the Achenbach Rating Scales (Child Behavior Checklist and Youth Self-Report)
Description
Measures parent and child report of the presence of child behavior and emotional problems
Time Frame
10 weeks - Measured at Week 1 (pre-treatment) and at Week 10 (post-treatment)
Title
Change in pre- vs. post-treatment scores on the Alabama Parenting Questionnaire
Description
Measures five dimensions of parenting: positive involvement, supervision, positive discipline techniques, consistency in disciplining, and use of corporal punishment.
Time Frame
10 weeks - Measured at Week 1 (pre-treatment) and at Week 10 (post-treatment)
Title
Parents' satisfaction with treatment, as measured by the Family Satisfaction Survey
Description
To assess parents' satisfaction with their participation in the UP-C intervention.
Time Frame
10 weeks - Measured at weeks 3, 7, and 10.
Title
Treatment feasibility, as measured by the Family Satisfaction Survey and attendance rates
Description
To evaluate parents' opinions about whether participation in a 10-week therapy group treatment is feasible and whether the interventions taught are feasible.
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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:
are unwilling to participate in the study
are non-English speaking
have an intellectual disability
have a pervasive developmental disability or
a significant developmental delay
do not have legal custody of the child participant
do not reside in the same home as the child participant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Malmberg, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Single subject design data
Citations:
Citation
Ehrenreich-May et al., 2012
Results Reference
background
Learn more about this trial
Transdiagnostic Group Intervention for Children With Behavior Problems
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