NCT02794051

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 8, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 29, 2016

Status Verified

September 1, 2016

Enrollment Period

4 months

First QC Date

May 17, 2016

Last Update Submit

September 28, 2016

Conditions

Behavioral SymptomsEmotional Disturbances

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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)

  • 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)

  • 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)

  • 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)

  • Parents' satisfaction with treatment, as measured by the Family Satisfaction Survey

    10 weeks - Measured at weeks 3, 7, and 10.

  • +1 more secondary outcomes

Study Arms (1)

Unified Protocol for Children

EXPERIMENTAL

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

Interventions

Group TherapyBEHAVIORAL

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

Unified Protocol for Children

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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:
  • are unwilling to participate in the study
  • are non-English speaking
  • have an intellectual disability
  • have a pervasive developmental disability or
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

  • Ehrenreich-May et al., 2012

    BACKGROUND

MeSH Terms

Conditions

Behavioral SymptomsAffective Symptoms

Interventions

Psychotherapy, Group

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Socioenvironmental TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jessica Malmberg, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2016

First Posted

June 8, 2016

Study Start

May 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

September 29, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will share

Single subject design data

Locations

US(1)