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Transdiagnostic Group Intervention for Children With Behavior Problems

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ClinicalTrials.gov Identifier: NCT02794051
Recruitment Status : Completed
First Posted : June 8, 2016
Last Update Posted : September 29, 2016
Sponsor:
Collaborator:
Children's Hospital Colorado
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date  ICMJE May 17, 2016
First Posted Date  ICMJE June 8, 2016
Last Update Posted Date September 29, 2016
Study Start Date  ICMJE May 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2016)
Change in rates of noncompliance, tantruming, and parenting practices on the Home Record Card [ Time Frame: 12 weeks - Measured daily from baseline to post-treatment ]
Chart for recording events of noncompliance, tantrums, and parenting practices.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2016)
  • Change in pre- vs. post-treatment scores on the Transdiagnostic Questionnaires for Parent and Child [ Time Frame: 10 weeks - Measured at Week 1 (pre-treatment) and at Week 10 (post-treatment) ]
    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 [ Time Frame: 10 weeks - Measured at Week 1 (pre-treatment) and at Week 10 (post-treatment) ]
    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) [ Time Frame: 10 weeks - Measured at Week 1 (pre-treatment) and at Week 10 (post-treatment) ]
    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 [ Time Frame: 10 weeks - Measured at Week 1 (pre-treatment) and at Week 10 (post-treatment) ]
    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 [ Time Frame: 10 weeks - Measured at weeks 3, 7, and 10. ]
    To assess parents' satisfaction with their participation in the UP-C intervention.
  • Treatment feasibility, as measured by the Family Satisfaction Survey and attendance rates [ Time Frame: 10 weeks ]
    To evaluate parents' opinions about whether participation in a 10-week therapy group treatment is feasible and whether the interventions taught are feasible.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transdiagnostic Group Intervention for Children With Behavior Problems
Official Title  ICMJE Implementation of a Transdiagnostic Group Intervention for Children With Behavior Problems Within a Pediatric Outpatient Setting
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Behavioral Symptoms
  • Emotional Disturbances
Intervention  ICMJE Behavioral: Group Therapy
Participating children and their caregivers will attend 90-minute weekly group therapy sessions for 10 consecutive weeks.
Study Arms  ICMJE Experimental: Unified Protocol for Children
Child participants with behavior problems between the ages of 8-12 and their caregivers will participate in a transdiagnostic group therapy protocol.
Intervention: Behavioral: Group Therapy
Publications * Ehrenreich-May et al., 2012

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 28, 2016)
8
Original Estimated Enrollment  ICMJE
 (submitted: June 2, 2016)
16
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02794051
Other Study ID Numbers  ICMJE 16-0275
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Single subject design data
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE Children's Hospital Colorado
Investigators  ICMJE
Principal Investigator: Jessica Malmberg, PhD University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP