Transdiagnostic Group Intervention for Children With Behavior Problems

NCT ID: NCT02794051

Last Updated: 2016-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2016-09-30

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.

Conditions

Behavioral Symptoms; Emotional Disturbances

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Group Therapy

Intervention Type: BEHAVIORAL

Participating children and their caregivers will attend 90-minute weekly group therapy sessions for 10 consecutive weeks.

Interventions

Group Therapy

Participating children and their caregivers will attend 90-minute weekly group therapy sessions for 10 consecutive weeks.

Intervention Type: BEHAVIORAL

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:

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Colorado

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica Malmberg, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

Children's Hospital Colorado

Aurora, Colorado, United States

Countries

United States

References

Ehrenreich-May et al., 2012

Reference Type: BACKGROUND

Other Identifiers

16-0275

Identifier Type: -

Identifier Source: org_study_id