Clinical trial NCT01915160: Technology-Based Tools to Enhance Quality of Care in Mental Health Treatment
Official title: Technology-Based Tools to Enhance Quality of Care in Mental Health Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2013-08-02
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Child Involvement Ratings Scale
timeFrame: post-treatment; will be assessed throughout the course of treatment (expected to be 12-20 weeks in duration for each participant)
measure: Treatment Adherence Checklist-Revised
timeFrame: post-treatment; will be assessed throughout the course of treatment; an expected duration of 12-20 weeks
Secondary outcomes:
measure: Kiddie Schedule for Affective Disorders and Schizophrenia for School Age Children - Present and Lifetime Version (K-SADS-PL PTSD module)
timeFrame: 12-20 weeks
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of SC
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Kenneth J Ruggiero, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Davidson TM, Bunnell BE, Saunders BE, Hanson RF, Danielson CK, Cook D, Chu BC, Dorsey S, Adams ZW, Andrews AR 3rd, Walker JH, Soltis KE, Cohen JA, Deblinger E, Ruggiero KJ. Pilot Evaluation of a Tablet-Based Application to Improve Quality of Care in Child Mental Health Treatment. Behav Ther. 2019 Mar;50(2):367-379. doi: 10.1016/j.beth.2018.07.005. Epub 2018 Jul 27.
citation: Ruggiero KJ, Bunnell BE, Andrews Iii AR, Davidson TM, Hanson RF, Danielson CK, Saunders BE, Soltis K, Yarian C, Chu B, Adams ZW. Development and Pilot Evaluation of a Tablet-Based Application to Improve Quality of Care in Child Mental Health Treatment. JMIR Res Protoc. 2015 Dec 30;4(4):e143. doi: 10.2196/resprot.4416.