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NCT Number: NCT02794051

Transdiagnostic Group Intervention for Children With Behavior Problems

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.

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Key information

Conditions

Behavioral Symptoms Affective Symptoms Behavior Emotional Disturbances

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • are unwilling to participate in the study
  • are non-English speaking
  • have an intellectual disability
  • have a pervasive developmental disability or
  • a significant developmental delay
  • do not have legal custody of the child participant
  • do not reside in the same home as the child participant

Treatment and study plan

Group Therapy

Behavioral

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

Primary outcomes

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

    Time frame: 12 weeks - Measured daily from baseline to post-treatment

    Chart for recording events of noncompliance, tantrums, and parenting practices.

Secondary outcomes

  1. Change in pre- vs. post-treatment scores on the Transdiagnostic Questionnaires for Parent and Child

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Children's Hospital Colorado

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 8, 2016
Registry last updated
Sep 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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