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Transdiagnostic Group Intervention for Children With Behavior Problems

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02794051
Recruitment Status : Completed
First Posted : June 8, 2016
Last Update Posted : September 29, 2016
Children's Hospital Colorado
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Behavioral Symptoms Emotional Disturbances Behavioral: Group Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Implementation of a Transdiagnostic Group Intervention for Children With Behavior Problems Within a Pediatric Outpatient Setting
Study Start Date : May 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Arm Intervention/treatment
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.
Behavioral: Group Therapy
Participating children and their caregivers will attend 90-minute weekly group therapy sessions for 10 consecutive weeks.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02794051

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United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Children's Hospital Colorado
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Principal Investigator: Jessica Malmberg, PhD University of Colorado, Denver
Ehrenreich-May et al., 2012

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Responsible Party: University of Colorado, Denver Identifier: NCT02794051    
Other Study ID Numbers: 16-0275
First Posted: June 8, 2016    Key Record Dates
Last Update Posted: September 29, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Single subject design data
Additional relevant MeSH terms:
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Problem Behavior
Behavioral Symptoms
Affective Symptoms