Improving Quality of Care in Child Mental Health Service Settings

Not Applicable

Completed

• Conditions: Technology; Post Traumatic Stress Disorder; Child Abuse
• Interventions: Behavioral: TFCBT; Behavioral: eTFCBT

• Registration Number: NCT03305458
• Lead Sponsor: Medical University of South Carolina

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-10-04
• Study First Submitted QC: 2017-10-04
• Study First Posted: 2017-10-10
• Study Start: 2018-10-01
• Primary Completion: 2023-02-27
• Study Completion: 2023-10-23
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 259

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment as usual	TFCBT	Trauma Focused Cognitive Behavioral Therapy
Tablet-Facilitated TF-CBT	eTFCBT	Standard treatment with the addition of in-treatment/session iPad activities

Primary Outcome Measures

Name	Time	Method
Provider Treatment Fidelity	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.
Child Involvement Ratings Scale	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).

Secondary Outcome Measures

Name	Time	Method
Center for Epidemiological Studies Depression Scale for Children (CES-DC)	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.
Working Alliance Inventory (WAI-short form)	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).
The Alabama Parenting Questionnaire	baseline, 3, 6, 9, 12 months post baseline	42-item measure to assess parenting practices.
The Shame Measure	baseline, 3, 6, 9, 12 months post baseline	4-item instrument that assesses feelings of shame following abuse.
Center for Epidemiologic Studies Depression Scale (CESD-R).	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.
Knowledge of Behavioral Principles as Applied to Children	baseline, post baseline	assess understanding of the application of behavioral principles to youth. Internal consistency=.42-.84; sensitivity to change.
Therapeutic Alliance Scale for Children (TASC)	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.
Child/Adolescent Satisfaction Questionnaire (CASQ).	baseline, 3, 6, 9, 12 months post baseline	The CASQ is a 15-item instrument that assesses child satisfaction with mental health treatment.
The Child and Adolescent Trauma Screen (CATS) - Youth Version	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.
Caregiver Satisfaction Questionnaire (CSQ)	baseline, 3, 6, 9, 12 months post baseline	The CSQ is a 15-item instrument that assesses caregiver satisfaction with mental health treatment.
Brief Problems Monitor (BPM)	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.
The Child and Adolescent Trauma Screen (CATS) - Caregiver Version	baseline, 3, 6, 9, 12 months post baseline	35-item parent version of the CATS-Youth.
The Kessler 6	baseline, 3, 6, 9, 12 months post baseline	widely used 6-item measure of general distress that is well-validated.
Evidence-Based Practice Attitude Scale (EBPAS)	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).
Acceptability, Appropriateness and Feasibility Measure (	baseline, post baseline	12-item measure to monitor and evaluate implementation efforts. This measure has been shown to have solid psychometric properties.
Computer Assisted Therapy Attitudes Scale	baseline, post baseline	8-item measure design to assess attitudes toward computer use in treatment.
Organizational Readiness for Implementing Change	baseline, post baseline	12-item measure designed to assess an organization's readiness to implement new policies, programs, and practices.
TF-CBT Organizational Support Measure	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).
Burnout Measure	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.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States