Transdiagnostic Group Intervention for Children With Behavior Problems

Implementation of a Transdiagnostic Group Intervention for Children With Behavior Problems Within a Pediatric Outpatient Setting

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.

Study Overview

• Status: Completed
• Conditions: Behavioral Symptoms; Emotional Disturbances
• Intervention / Treatment: Behavioral: Group Therapy

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: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in rates of noncompliance, tantruming, and parenting practices on the Home Record Card	Chart for recording events of noncompliance, tantrums, and parenting practices.	12 weeks - Measured daily from baseline to post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 weeks - Measured at Week 1 (pre-treatment) and at Week 10 (post-treatment)
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.	10 weeks - Measured at Week 1 (pre-treatment) and at Week 10 (post-treatment)
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	10 weeks - Measured at Week 1 (pre-treatment) and at Week 10 (post-treatment)
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.	10 weeks - Measured at Week 1 (pre-treatment) and at Week 10 (post-treatment)
Parents' satisfaction with treatment, as measured by the Family Satisfaction Survey	To assess parents' satisfaction with their participation in the UP-C intervention.	10 weeks - Measured at weeks 3, 7, and 10.
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.	10 weeks

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Children's Hospital Colorado
• Investigators: Principal Investigator: Jessica Malmberg, PhD, University of Colorado, Denver

Publications and helpful links

General Publications

• Ehrenreich-May et al., 2012

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: May 17, 2016
• First Submitted That Met QC Criteria: June 2, 2016
• First Posted (Estimate): June 8, 2016

Study Record Updates

• Last Update Posted (Estimate): September 29, 2016
• Last Update Submitted That Met QC Criteria: September 28, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Problem Behavior; Behavioral Symptoms; Affective Symptoms
• Other Study ID Numbers: 16-0275

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Single subject design data