Improving Quality of Care in Child Mental Health Service Settings

NCT03305458 | Completed Results DMC

• 1 other identifier: R01MH110620
• Study Type: interventional
• Target: 713
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Traumatic Stress Disorder; Technology; Child Abuse

Outcome Measures

Primary Outcomes (2)

• Child Involvement Ratings Scale (CIRS)

  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) will be used to code child engagement. Ten "child involvement" items-6 positive, 4 negative- are rated for each session on a 6-point scale. The minimum total score will be 0 and the maximum score is 50. For the outcome, a single average value will be presented. 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). Screening was conducted on enrolled participants.

  3 Month Timeline

• Provider Treatment Fidelity (TPOCS)

  Fidelity to the TF-CBT protocol will be measured by independent, trained raters who are blind to the study purpose and hypotheses, coding audiotaped treatment sessions. The TF-CBT Version of the Therapy Process Observational Coding System for Child Psychotherapy (TF-CBT TPOCS-S), modified for the eTF-CBT condition, will be used to assess provider fidelity to each TF-CBT component. Two raters will review video-recorded treatment sessions, assessing the presence or absence of specific techniques and rating their extensiveness on a 6-point scale. The total score will range from a minimum of 0 to the maximum 78. The outcome will be presented as a single average value.

  3 Month Timeline

Secondary Outcomes (19)

• Center for Epidemiological Studies Depression Scale for Children (CES-DC)

  Baseline, 3 Month, 6 Month, 9 Month, 12 Month

• Therapeutic Alliance Scale for Children (TASC)

  3 Month

• Child/Adolescent Satisfaction Questionnaire (CASQ).

  3 Month

• The Shame Measure

  Baseline, 3 Month, 6 Month, 9 Month, 12 Month

• The Child and Adolescent Trauma Screen (CATS) - Youth Version

  Baseline, 3 Month, 6 Month, 9 Month, 12 Month

Study Arms (2)

Treatment as usual

ACTIVE COMPARATOR

Trauma Focused Cognitive Behavioral Therapy

Behavioral: TFCBT

Tablet-Facilitated TF-CBT

EXPERIMENTAL

Standard treatment with the addition of in-treatment/session iPad activities

Behavioral: eTFCBT

Interventions

TFCBT BEHAVIORAL

treatment as usual

Treatment as usual

eTFCBT BEHAVIORAL

tablet-facilitated Trauma Focused Cognitive Behavioral Therapy (eTFCBT)

Tablet-Facilitated TF-CBT

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Tatiana Davidson
• Organization: Medical University of South Carolina

davidst@musc.edu

8437921866

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: October 10, 2017
• Study Start: October 1, 2018
• Primary Completion: February 27, 2023
• Study Completion: October 26, 2023
• Last Updated: June 6, 2025
• Results First Posted: June 6, 2025

Record last verified: 2025-05

Locations

US (1)