Using Smartphones to Enhance the Treatment of Childhood Anxiety

NCT02259036 | Completed

• 2 other identifiers: MH1026661R34MH102666-01A1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal of this research study is to develop an interactive smartphone app that could be used to increase the effectiveness of talk therapy such as cognitive behavioral therapy (CBT) for child anxiety.

Conditions

Anxiety

Keywords

child anxiety; worries; fears; talk therapy

Outcome Measures

Primary Outcomes (1)

• PARS Treatment response

  Anxiety severity will be rated by an IE on the Pediatric Anxiety Rating Scale (PARS) (RUPP Study Group, 2002). A total score was computed by summing six items assessing anxiety severity, frequency, distress, avoidance, and interference during the previous week. Treatment response will be defined as a 35% reduction in PARS from pre- to post-treatment.

  10 weeks

Secondary Outcomes (1)

• Absence of diagnosis on K-SADS

  10 weeks

Other Outcomes (2)

• child report of anxiety

  10 weeks

• parent report of anxiety

  10 weeks

Study Arms (1)

SmartCAT Enhanced Treatment

OTHER

Cognitive Behavioral Therapy enhanced with an ecological momentary treatment enhancement smartphone app called SmartCAT.

Other: Ecological Momentary Treatment Enhancement

Interventions

Ecological Momentary Treatment Enhancement OTHER

Participants will be given a pre-programmed smartphone on which they will enter their responses to a series of questions about moods and daily experiences using an app developed for this study. The child will receive an electronic notification message once per day and will be prompted through a series of questions about what he/she is doing, who he/she is with, how he/she is feeling, worries or stressful events, and how he/she coped with these events. It should take the child approximately 5 minutes each time to complete the questions. Participant data will be sent to study therapists to be reviewed weekly. The therapist will integrate this information into treatment and provide customized feedback to the patient.

SmartCAT Enhanced Treatment

Eligibility Criteria

• Age: 9 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Participants will be 40 children of either sex ages 9 years, 0 months to 14 years, 11 months with DSM-IV diagnosis of Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), and/or Social Phobia (SP) as identified by the Kiddie Schedule of Affective Disorders.
• The primary caregiver is defined as the person who has the most responsibility for taking care of the child. While this is typically the mother, it can be the father, an adoptive parent or other legal guardian. The primary caregiver must be a legal guardian of the child.

You may not qualify if:

• Requires current ongoing treatment with psychoactive medications other than stimulants.
• Acutely suicidal or at risk for harm to self or others.
• Neuromuscular or neurological disorder.
• Reading level below 80 on the Wide Range Achievement Test-4 (WRAT-4)
• Medical illnesses or medications taken for an illness as determined by study physicians that would affect study adherence, and subject's emotional state.
• Current comorbid diagnosis of: primary major depressive disorder (MDD) (subjects who have primary GAD with co-morbid MDD that is secondary in terms of course and functional impact are not excluded), obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), conduct disorder, substance abuse or dependence, and ADHD combined type or predominantly hyperactive-impulsive type.
• Lifetime diagnosis of autism spectrum disorder, bipolar disorder, psychotic depression, schizophrenia, or schizoaffective disorder.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Pittsburgh, Dept. of Psychology

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (22)

• Achenbach, T. M. (1991). Manual for the Child Behavior Checklist/4-18 and 1991 Profile. Burlington: University of Vermont, Department of Psychiatry.

  BACKGROUND

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  BACKGROUND

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  BACKGROUND

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  PMID: 10517055 BACKGROUND

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  PMID: 11142550 BACKGROUND

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  BACKGROUND

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  PMID: 8034812 BACKGROUND

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  PMID: 15142397 BACKGROUND

• Reynolds S, Wilson C, Austin J, Hooper L. Effects of psychotherapy for anxiety in children and adolescents: a meta-analytic review. Clin Psychol Rev. 2012 Jun;32(4):251-62. doi: 10.1016/j.cpr.2012.01.005. Epub 2012 Feb 13.

  PMID: 22459788 BACKGROUND

• Pine DS, Cohen P, Gurley D, Brook J, Ma Y. The risk for early-adulthood anxiety and depressive disorders in adolescents with anxiety and depressive disorders. Arch Gen Psychiatry. 1998 Jan;55(1):56-64. doi: 10.1001/archpsyc.55.1.56.

  PMID: 9435761 BACKGROUND

• Ronan, K. R., Kendall, P. C., & Rowe, M. (1994). Negative affectivity in children: Development and validation of a self-statement questionnaire. Cognitive Therapy and Research, 18(6), 509-528.

  BACKGROUND

• The Pediatric Anxiety Rating Scale (PARS): development and psychometric properties. J Am Acad Child Adolesc Psychiatry. 2002 Sep;41(9):1061-9. doi: 10.1097/00004583-200209000-00006.

  PMID: 12218427 BACKGROUND

• Silk JS, Dahl RE, Ryan ND, Forbes EE, Axelson DA, Birmaher B, Siegle GJ. Pupillary reactivity to emotional information in child and adolescent depression: links to clinical and ecological measures. Am J Psychiatry. 2007 Dec;164(12):1873-80. doi: 10.1176/appi.ajp.2007.06111816.

  PMID: 18056243 BACKGROUND

• Silk JS, Forbes EE, Whalen DJ, Jakubcak JL, Thompson WK, Ryan ND, Axelson DA, Birmaher B, Dahl RE. Daily emotional dynamics in depressed youth: a cell phone ecological momentary assessment study. J Exp Child Psychol. 2011 Oct;110(2):241-57. doi: 10.1016/j.jecp.2010.10.007. Epub 2010 Nov 26.

  PMID: 21112595 BACKGROUND

• Silk JS, Steinberg L, Morris AS. Adolescents' emotion regulation in daily life: links to depressive symptoms and problem behavior. Child Dev. 2003 Nov-Dec;74(6):1869-80. doi: 10.1046/j.1467-8624.2003.00643.x.

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• Zeman, J., Shipman, K., & Penza Clyve, S. (2001). Development and initial validation of the Children's Sadness Management Scale. Journal of Nonverbal Behavior, 25(3), 187-205.

  BACKGROUND

• Ziegert DI, Kistner JA. Response styles theory: downward extension to children. J Clin Child Adolesc Psychol. 2002 Sep;31(3):325-34. doi: 10.1207/S15374424JCCP3103_04.

  PMID: 12149970 BACKGROUND

• McCormack CC, Mennies RJ, Silk JS, Stone LB. How anxious is too anxious? State and trait physiological arousal predict anxious youth's treatment response to brief cognitive behavioral therapy. BMC Psychol. 2020 May 12;8(1):48. doi: 10.1186/s40359-020-00415-3.

  PMID: 32398128 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Jennifer S Silk, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: September 24, 2014
• First Posted: October 8, 2014
• Study Start: August 1, 2014
• Primary Completion: May 31, 2017
• Study Completion: May 31, 2017
• Last Updated: November 16, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)