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

NCT01915160 | Completed DMC

• 1 other identifier: 1R34MH096907-01A1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (2)

• Child Involvement Ratings Scale

  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

  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 Outcomes (1)

• Kiddie Schedule for Affective Disorders and Schizophrenia for School Age Children - Present and Lifetime Version (K-SADS-PL PTSD module)

  12-20 weeks

Study Arms (2)

treatment as usual

ACTIVE COMPARATOR

Trauma Focused- Cognitive Behavioral Therapy (TF-CBT)

Behavioral: TF-CBT

tablet assisted therapy toolkit

EXPERIMENTAL

electronically assisted Trauma Focused-Cognitive Behavioral Therapy (eTF-CBT)

Behavioral: eTF-CBT

Interventions

eTF-CBT BEHAVIORAL

Standard treatment with the edition of in-treatment/session iPad activities.

tablet assisted therapy toolkit

TF-CBT BEHAVIORAL

Treatment as usual.

treatment as usual

Eligibility Criteria

• Age: 8 Years - 15 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 SC

Charleston, South Carolina, 294258908, United States

Location

Related Publications (2)

• 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.

  PMID: 30824252 DERIVED

• 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.

  PMID: 26717906 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

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

Study Officials

• Kenneth J Ruggiero, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

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: July 1, 2013
• First Posted: August 2, 2013
• Study Start: November 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 30, 2016

Record last verified: 2012-08

Locations

US (1)