Behavioral SymptomsNCT02794051
Transdiagnostic Group Intervention for Children With Behavior Problems
A study testing Group Therapy in people with Behavioral Symptoms and Emotional Disturbances, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Behavioral Symptoms, Emotional Disturbances
- What is being tested?
- Group Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Official title: 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.
Read the 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
- Being tested
- Group Therapy
- Medical subject headings
- Behavioral Symptoms, Affective Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group TherapyBehavioural
Participating children and their caregivers will attend 90-minute weekly group therapy sessions for 10 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Group Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in rates of noncompliance, tantruming, and parenting practices on the Home Record Card
Chart for recording events of noncompliance, tantrums, and parenting practices.
Measured: 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
Measures several transdiagnostic mechanisms including child emotional and behavioral symptoms, sleeping difficulties, and parenting practices.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Behavioral SymptomsStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Colorado
- Responsible party
- Sponsor
- Investigators
- Jessica Malmberg, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02794051
- Sponsor's protocol ID
- 16-0275
- Status last verified
- Sep 2016
- First submitted
- 17 May 2016
- Last updated
- 29 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Single subject design data
Publications
Ehrenreich-May et al., 2012
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Transdiagnostic Group Intervention for Children With Behavior Problems Within a Pediatric Outpatient Setting
- ClinicalTrials.gov ID
- NCT02794051
- Acronym / sponsor ID
- 16-0275
- Conditions
- Behavioral Symptoms, Emotional Disturbances
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Children's Hospital Colorado
- Study start
- May 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 8 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unified Protocol for Children | Experimental | Behavioral: Group TherapyChild participants with behavior problems between the ages of 8-12 and their caregivers will participate in a transdiagnostic group therapy protocol. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- Child is: a ward of the state
- has active suicidal ideation
- has homicidal ideation
- has self-harm behaviors
- has an intellectual disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group TherapyParticipating children and their caregivers will attend 90-minute weekly group therapy sessions for 10 consecutive weeks. | Behavioural | Unified Protocol for Children |
Primary outcome
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.
6 secondary outcomes
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)
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)
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)
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)
Parents' satisfaction with treatment, as measured by the Family Satisfaction Survey
Time frame: 10 weeks - Measured at weeks 3, 7, and 10.
Treatment feasibility, as measured by the Family Satisfaction Survey and attendance rates
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2016.
- BackgroundEhrenreich-May et al., 2012
- Individual participant dataSharing planned: Yes. Single subject design data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Malmberg, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Therapy in people with Behavioral Symptoms and Emotional Disturbances, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02794051, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2016.