Technology-Based Tools to Enhance Quality of Care in Mental Health Treatment
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|ClinicalTrials.gov Identifier: NCT01915160|
Recruitment Status : Completed
First Posted : August 2, 2013
Last Update Posted : September 30, 2016
|Condition or disease||Intervention/treatment||Phase|
|Post Traumatic Stress Disorder||Behavioral: eTF-CBT Behavioral: TF-CBT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Technology-Based Tools to Enhance Quality of Care in Mental Health Treatment|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||August 2016|
Active Comparator: treatment as usual
Trauma Focused- Cognitive Behavioral Therapy (TF-CBT)
Treatment as usual.
Experimental: tablet assisted therapy toolkit
electronically assisted Trauma Focused-Cognitive Behavioral Therapy (eTF-CBT)
Standard treatment with the edition of in-treatment/session iPad activities.
- 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).
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01915160
|United States, South Carolina|
|Medical University of SC|
|Charleston, South Carolina, United States, 294258908|
|Principal Investigator:||Kenneth J Ruggiero, PhD||Medical University of South Carolina|