Technology-Based Tools to Enhance Quality of Care in Mental Health Treatment

September 29, 2016 updated by: Medical University of South Carolina
Nearly 9 million U.S. children (1 in 8) meet criteria for at least one mental health disorder at any point in time. Effective treatments exist for these disorders, but children and families who seek services rarely receive them; mental health providers need more support in the delivery of these interventions to ensure that children and families are receiving the best quality care. This project aims to improve the delivery of best practices for families who seek mental health care by developing creative, technology-based resources for providers. Once we have completed development of the tablet-based resources, we will conduct a small randomized study with 20 families to examine the feasibility and prepare for a large study to test the effectiveness of the resources.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Efficacious treatments exist for a wide range of psychiatric disorders, but these treatments rarely are delivered with high fidelity in mental health service settings. Research is needed to ensure that these treatments become more accessible in day-to-day clinical care. Innovative, low-cost approaches are essential, particularly in settings where resources are limited. Technological advances have made possible the development of low-cost and highly efficient (i.e., minimal time burden to providers) resources that can be delivered via internet, tablets, Smartphone, and other technologies to improve quality of care. Research is needed to inform these efforts and evaluate the feasibility and utility of this approach. Widespread availability of technology-based resources may represent an important step toward making evidence-based treatment more accessible to children and adults if research supports their utility. Our research team has led the development and evaluation of several e-health and e-learning tools for patients and providers. This has positioned us well to develop and rigorously evaluate a technology-based toolkit to enhance providers' delivery of evidence-based treatment. Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), an empirically supported treatment for children with posttraumatic stress reactions, is widely used by community providers and is ideal for testing the use of technology-based resources because the protocol addresses multiple symptom domains as well as both children and caregivers. We propose to develop and examine the feasibility of a technology-based toolkit for TF-CBT (e-TFCBT) that is designed to enhance the quality, accessibility, and efficacy of treatment. The toolkit will consist of web-based applications that are optimized for use on mobile devices. We conducted an interview of 21 nationally certified trainers in TF-CBT to guide an initial list of resources that are intended to address known problems with fidelity and engagement. Providers will use most of these resources in session to maximize fidelity and enhance child engagement and learning. The resources will be alpha-tested with families and providers and then beta-tested with providers; qualitative data will be used to guide refinements to the toolkit. We will then conduct a feasibility trial with 20 families. Results will provide valuable preliminary data in preparation for a randomized controlled trial to examine the additive benefits of web-accessible resources that assist providers in high-fidelity delivery of evidence-based care.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 294258908
        • Medical University Of SC

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 15 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: treatment as usual
Trauma Focused- Cognitive Behavioral Therapy (TF-CBT)
Behavioral: TF-CBT
Treatment as usual.
Experimental: tablet assisted therapy toolkit
electronically assisted Trauma Focused-Cognitive Behavioral Therapy (eTF-CBT)
Behavioral: eTF-CBT
Standard treatment with the edition of in-treatment/session iPad activities.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Child Involvement Ratings Scale
Time Frame: post-treatment; 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).
post-treatment; will be assessed throughout the course of treatment (expected to be 12-20 weeks in duration for each participant)
Treatment Adherence Checklist-Revised
Time Frame: post-treatment; 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 audiotaped treatment sessions by independent, trained raters who are blind to study purpose and hypotheses. Ratings will be completed using the Treatment Adherence Checklist-Revised, 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. An additional 8 items focus on general therapy skills, not specific to TF-CBT, including establishing an agenda, providing a treatment rationale, and assigning homework. Additional items were created to identify use of eTF-CBT tools to differentiate the two treatment conditions. Two independent raters will listen to tape-recorded treatment session tapes and complete the modified TAC-R to code the presence/absence of specific treatment techniques depicted on the tapes.
post-treatment; will be assessed throughout the course of treatment; an expected duration of 12-20 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Kiddie Schedule for Affective Disorders and Schizophrenia for School Age Children - Present and Lifetime Version (K-SADS-PL PTSD module)
Time Frame: 12-20 weeks
This is a semi-structured interview that is well-established and widely used. It has been used in numerous TF-CBT RCTs. We also will assess functional impairment in school, social, and family life using the K-SADS-PL instrument.
12-20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of South Carolina

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kenneth J Ruggiero, PhD, Medical University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 2, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 30, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1R34MH096907-01A1 (U.S. NIH Grant/Contract)

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.

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