Transdiagnostic Group Intervention for Children With Behavior Problems

Sponsor
University of Colorado, Denver (Other)
Overall Status
Completed
CT.gov ID
NCT02794051
Collaborator
Children's Hospital Colorado (Other)
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Group Therapy
N/A

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 Design

Study Type:
Interventional
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 1, 2016
Actual Primary Completion Date :
Sep 1, 2016
Actual Study Completion Date :
Sep 1, 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in rates of noncompliance, tantruming, and parenting practices on the Home Record Card [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 [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 [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) [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 12 Years
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Children's Hospital Colorado Aurora Colorado United States 80045

Sponsors and Collaborators

  • University of Colorado, Denver
  • Children's Hospital Colorado

Investigators

  • Principal Investigator: Jessica Malmberg, PhD, University of Colorado, Denver

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT02794051
Other Study ID Numbers:
  • 16-0275
First Posted:
Jun 8, 2016
Last Update Posted:
Sep 29, 2016
Last Verified:
Sep 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 29, 2016