Transdiagnostic Group Intervention for Children With Behavior Problems

Behavioral Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02794051
• Other study ID #: 16-0275
• Status: Completed
• Phase: N/A
• First received: May 17, 2016
• Last updated: September 28, 2016
• Start date: May 2016
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 12 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Affective Symptoms
• Behavioral Symptoms
• Emotional Disturbances
• Problem Behavior

Intervention

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

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Children's Hospital Colorado

Country where clinical trial is conducted

United States, 

References & Publications (1)

Ehrenreich-May et al., 2012

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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.	No
Secondary	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	No