- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03305458
Improving Quality of Care in Child Mental Health Service Settings
November 28, 2023 updated by: Medical University of South Carolina
The investigators recently completed an NIMH R34 in which they piloted a patient- and provider-informed tablet-based toolkit designed to facilitate delivery of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) - a treatment that was selected because it addresses a wide range of symptoms using techniques shared by other treatments for emotional and behavioral disorders.
The tablet-based toolkit consists of numerous components (e.g., videos, interactive games, drawing applications) that are designed to facilitate provider-patient interactions in a way that enhances children's engagement and supports adherence to the treatment model.
The tablet-based toolkit was very well received by children, caregivers, and providers in the pilot evaluation.
Moreover, all benchmarks for feasibility were met or exceeded.
This study proposes to conduct a hybrid effectiveness-implementation trial to examine the extent to which the tablet intervention may improve fidelity, engagement, and children's mental health outcomes.
The investigators will conduct a randomized controlled trial with 120 mental health providers and 360 families in partnership with dozens of clinics in the Carolinas and Florida.
Providers will be assigned randomly to tablet-facilitated vs. standard TF-CBT.
Youth aged 8-16 years with clinically elevated symptoms of PTSD will be recruited.
Baseline and 3-, 6-, 9-, and 12-month post-baseline assessments will be conducted by independent, blind evaluators.
Sessions will be videorecorded for observational coding of engagement and fidelity by independent raters blind to study hypotheses.
The investigators will also examine costs and conduct semi-structured interviews with families, providers, supervisors, and agency leaders to inform future dissemination and implementation initiatives.
Technology-based resources that are scalable, easy to use, and designed for efficient integration into everyday practice may have sustained national impact.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Assuring children access to the highest quality mental health care is a top national priority.
Yet, quality of care continues to be highly variable in traditional service settings.
Novel, scalable solutions are needed to address modifiable quality-of-care indicators in sustainable ways.
To this end, provider fidelity and children's engagement are key correlates of clinical outcome and practical targets for intervention.
There is tremendous opportunity to address both through technology.
Studies in child education show that interactive games, touch-screen learning, and demonstration videos enhance engagement, knowledge, motivation, and learning.
These benefits also may extend to the therapeutic context, where strategic integration of technology-based activities may enhance children's learning, strengthen the therapeutic alliance, and keep providers on protocol.
The investigators recently completed an NIMH R34 in which they piloted a patient- and provider-informed tablet-based toolkit designed to facilitate delivery of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) - a treatment that was selected because it addresses a wide range of symptoms using techniques shared by other treatments for emotional and behavioral disorders.
The tablet-based toolkit consists of numerous components (e.g., videos, interactive games, drawing applications) that are designed to facilitate provider-patient interactions in a way that enhances children's engagement and supports adherence to the treatment model.
The tablet-based toolkit was very well received by children, caregivers, and providers in the picot evaluation and all benchmarks for feasibility were met or exceeded.
The investigators propose to conduct a hybrid effectiveness-implementation trial to examine the extent to which the tablet intervention may improve fidelity, engagement, and children's mental health outcomes.
The investigators will conduct a randomized controlled trial with 120 mental health providers and 360 families in partnership with dozens of clinics in the Carolinas and Florida.
Providers will be assigned randomly to tablet-facilitated vs. standard TF-CBT.
Youth aged 8-16 years with clinically elevated symptoms of PTSD will be recruited.
Baseline and 3-, 6-, 9-, and 12-month post-baseline assessments will be conducted by independent, blind evaluators.
Sessions will be videorecorded for observational coding of engagement and fidelity by independent raters blind to study hypotheses.
The investigators will also examine costs and conduct semi-structured interviews with families, providers, supervisors, and agency leaders to inform future dissemination and implementation initiatives.
Technology-based resources that are scalable, easy to use, and designed for efficient integration into everyday practice may have sustained national impact.
Study Type
Interventional
Enrollment (Actual)
259
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kenneth J Ruggiero, PhD
- Phone Number: 843-792-3687
- Email: ruggierk@musc.edu
Study Contact Backup
- Name: Tonya Hazelton, MA
- Phone Number: 843-792-2517
- Email: hazelto@musc.edu
Study Locations
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 16 years (Child)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- victim of at least one potentially traumatic event (e.g. sexual/physical assault, witnessed violence, disaster, serious accident)
- have at least one symptom on each PTSD symptom cluster (re-experiencing, avoidance, hyperarousal)
Exclusion Criteria:
- exhibits psychotic symptoms (active hallucinations, delusions, impaired thought processes) by caregiver or child
- significant cognitive disabilities, developmental delays, or pervasive developmental disorder
- active suicidal or homicidal ideations
- no consistent caregiver available to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Treatment as usual
Trauma Focused Cognitive Behavioral Therapy
|
treatment as usual
|
Experimental: Tablet-Facilitated TF-CBT
Standard treatment with the addition of in-treatment/session iPad activities
|
tablet-facilitated Trauma Focused Cognitive Behavioral Therapy (eTFCBT)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Child Involvement Ratings Scale
Time Frame: will be assessed throughout the course of treatment (expected to be 12-20 weeks in duration for each participant)
|
Child engagement will be measured via coding of audiotaped sessions by independent, trained raters who are blind to study purpose and hypotheses.
The Child Involvement Ratings Scale (CIRS), a 6-item scale that measures child engagement for each session, will be used.
Four "positive" involvement items and two "negative" involvement items are rated for each session on a 6-point scale ("not at all" to "a great deal" present).
The positive-involvement items emphasize the extent to which children initiate discussions, demonstrate enthusiasm, self-disclose, and demonstrate understanding.
Negative-involvement items address withdrawal or avoidance in treatment.
Coders provide ratings based on two 10-min segments of session audiotapes (beginning at min 10 and min 40).
|
will be assessed throughout the course of treatment (expected to be 12-20 weeks in duration for each participant)
|
Provider Treatment Fidelity
Time Frame: will be assessed throughout the course of treatment; an expected duration of 12-20 weeks
|
Fidelity to the TF-CBT protocol will be measured via coding of videotaped treatment sessions by independent, trained raters who are blind to study purpose and hypotheses.
Ratings will be completed using the TF-CBT Version of the Therapy Process Observational Coding System for Child Psychotherapy (TF-CBT TPOCS-S), a behaviorally specific checklist of TF-CBT provider behavior that we have modified for the current study to ensure relevance to the eTF-CBT condition.
This checklist will be used to calculate providers' fidelity to each TF-CBT component.
Two independent raters will listen to video-recorded treatment session tapes and complete the TF-CBT TPOCS-S to code the presence/absence of specific treatment techniques depicted on the tapes.
|
will be assessed throughout the course of treatment; an expected duration of 12-20 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Center for Epidemiological Studies Depression Scale for Children (CES-DC)
Time Frame: baseline, 3, 6, 9, 12 months post baseline
|
assesses the severity of depressive symptomatology in children.
It is a 20-item self-report measure with possible scores ranging from 0-60.
Scores over 15 are indicative of significant levels of depressive symptoms.
|
baseline, 3, 6, 9, 12 months post baseline
|
Therapeutic Alliance Scale for Children (TASC)
Time Frame: baseline, 3, 6, 9, 12 months post baseline
|
The TASC is an 8-item measure of the child's alliance with the therapist using a 4-pt scale.
It has good internal consistency and interrater reliability.
|
baseline, 3, 6, 9, 12 months post baseline
|
Child/Adolescent Satisfaction Questionnaire (CASQ).
Time Frame: baseline, 3, 6, 9, 12 months post baseline
|
The CASQ is a 15-item instrument that assesses child satisfaction with mental health treatment.
|
baseline, 3, 6, 9, 12 months post baseline
|
The Shame Measure
Time Frame: baseline, 3, 6, 9, 12 months post baseline
|
4-item instrument that assesses feelings of shame following abuse.
|
baseline, 3, 6, 9, 12 months post baseline
|
The Child and Adolescent Trauma Screen (CATS) - Youth Version
Time Frame: baseline, 3, 6, 9, 12 months post baseline
|
35-item instrument that assesses exposure to traumatic events and all 20 DSM-V symptoms of PTSD.
|
baseline, 3, 6, 9, 12 months post baseline
|
Caregiver Satisfaction Questionnaire (CSQ)
Time Frame: baseline, 3, 6, 9, 12 months post baseline
|
The CSQ is a 15-item instrument that assesses caregiver satisfaction with mental health treatment.
|
baseline, 3, 6, 9, 12 months post baseline
|
Working Alliance Inventory (WAI-short form)
Time Frame: baseline, 3, 6, 9, 12 months post baseline
|
The WAI is a 12-item measure of the parent-therapist alliance using a 7-point scale (never to always).
|
baseline, 3, 6, 9, 12 months post baseline
|
Brief Problems Monitor (BPM)
Time Frame: baseline, 3, 6, 9, 12 months post baseline
|
The BPM is a 19-item measure of emotional and behavioral functioning in children.
The BPM is well-validated and comparable to the lengthier Child Behavior Checklist.
|
baseline, 3, 6, 9, 12 months post baseline
|
Center for Epidemiologic Studies Depression Scale (CESD-R).
Time Frame: baseline, 3, 6, 9, 12 months post baseline
|
The CESD-R is a 20-item self-report scale of depression.
It is widely used and demonstrates excellent psychometric properties.
|
baseline, 3, 6, 9, 12 months post baseline
|
The Child and Adolescent Trauma Screen (CATS) - Caregiver Version
Time Frame: baseline, 3, 6, 9, 12 months post baseline
|
35-item parent version of the CATS-Youth.
|
baseline, 3, 6, 9, 12 months post baseline
|
The Alabama Parenting Questionnaire
Time Frame: baseline, 3, 6, 9, 12 months post baseline
|
42-item measure to assess parenting practices.
|
baseline, 3, 6, 9, 12 months post baseline
|
The Kessler 6
Time Frame: baseline, 3, 6, 9, 12 months post baseline
|
widely used 6-item measure of general distress that is well-validated.
|
baseline, 3, 6, 9, 12 months post baseline
|
Evidence-Based Practice Attitude Scale (EBPAS)
Time Frame: baseline, post baseline
|
15 items, assessing providers' perceptions of appeal of EBT, openness to innovation, perceived divergence with usual care (alphas .59-.90; M=.77).
|
baseline, post baseline
|
Knowledge of Behavioral Principles as Applied to Children
Time Frame: baseline, post baseline
|
assess understanding of the application of behavioral principles to youth.
Internal consistency=.42-.84;
sensitivity to change.
|
baseline, post baseline
|
Acceptability, Appropriateness and Feasibility Measure (
Time Frame: baseline, post baseline
|
12-item measure to monitor and evaluate implementation efforts.
This measure has been shown to have solid psychometric properties.
|
baseline, post baseline
|
Computer Assisted Therapy Attitudes Scale
Time Frame: baseline, post baseline
|
8-item measure design to assess attitudes toward computer use in treatment.
|
baseline, post baseline
|
Organizational Readiness for Implementing Change
Time Frame: baseline, post baseline
|
12-item measure designed to assess an organization's readiness to implement new policies, programs, and practices.
|
baseline, post baseline
|
TF-CBT Organizational Support Measure
Time Frame: baseline, post baseline
|
19-item instrument to assess a community mental health organization's activities related to the delivery of Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT).
|
baseline, post baseline
|
Burnout Measure
Time Frame: baseline, post baseline
|
screener that assesses providers' feelings about their work, and their perceptions of how their co-workers feel about the work they do.
|
baseline, post baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2018
Primary Completion (Actual)
February 27, 2023
Study Completion (Actual)
October 23, 2023
Study Registration Dates
First Submitted
October 4, 2017
First Submitted That Met QC Criteria
October 4, 2017
First Posted (Actual)
October 10, 2017
Study Record Updates
Last Update Posted (Actual)
November 29, 2023
Last Update Submitted That Met QC Criteria
November 28, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01MH110620 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Child Abuse
-
Oral Health Centre of Expertise in Western NorwayOral Health Center of Expertise Rogaland, Norway; Childrens advocacy center... and other collaboratorsRecruitingChild Abuse | Child Neglect | Child MaltreatmentNorway
-
University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development...Active, not recruiting
-
Yeditepe UniversityRecruitingEducational Program's Impact on Nursing Students' Knowledge and Awareness of Child Abuse and NeglectChild Abuse | Child NeglectTurkey
-
Karolinska InstitutetActive, not recruitingChild Abuse | Child MaltreatmentSweden
-
University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedChild Abuse | Child NeglectUnited States
-
Milton S. Hershey Medical CenterRecruitingChild Abuse | Child Neglect | Child MaltreatmentUnited States
-
University of ChicagoUniversity of California, Los Angeles; Oak Foundation; UBS Optimus Foundation; Trickle... and other collaboratorsCompletedChild Abuse | Child MaltreatmentBurkina Faso
-
University of PittsburghPatient-Centered Outcomes Research Institute; Northwell Health; University of...CompletedChild Abuse | Trauma | Child Maltreatment | Physical AbuseUnited States
-
McGill UniversitySave the Children; European Network of Foundations Children and Violence Evaluation... and other collaboratorsUnknown
-
Institute of Psychiatry, LondonBanaras Hindu University; Tribhuvan University, NepalCompletedChild Abuse | Child Neglect | VictimizationIndia, Nepal
Clinical Trials on TFCBT
-
University of California, Los AngelesAmerican Academy of Child Adolescent Psychiatry.; Kern MedicalCompletedAttention Deficit Hyperactivity Disorder | Posttraumatic Stress DisorderUnited States
-
Pakistan Institute of Living and LearningNot yet recruitingSuicidal Ideation | Trauma, Psychological