Study of Technology-assisted Treatment of Adolescent Depression (iTAD)
Information Technology Enabled Treatment of Adolescent Depression
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This Phase II SBIR project represents the continuing development of an Information Technology Enabled Disease Management System for Treatment of Adolescent Depression (iTAD) following a highly successful Phase I award in which all Specific Aims were met. The need for this system innovation arises from the substantial costs that inadequately treated adolescent Major Depressive Disorder (MDD) has on the course of adolescent development and society as a whole. Effective treatments involving the combined use of a Selective Serotonin Reuptake Inhibitor (SSRI) and the administration of Cognitive Behavioral Therapy (CBT) is considered the "modal treatment" for adolescent MM. Yet, multiple barriers interfere with the implementation and dissemination of this "gold standard' of care. These barriers include: under recognition of depressive symptoms by parents and pediatricians, inability to assess adolescent depression accurately and reliably in primary care settings, safety concerns related to pharmacologic treatment, monitoring of symptom changes and adverse treatment effects, such as irritability and suicidal behavior, treatment non-compliance, lack of access to an integrated medical and treatment history; and an alarming shortage of properly trained child and adolescent psychiatrists capable of implementing optimal treatment safely, reliably, and effectively.
In this current project, the investigators are making tailored forms of CBT broadly and easily accessible to the community, using the iTAD (previously "ITEMS-TAD") which is intended to address these problems. Development of the system has continued and we have modified the existing prototype that was created with funding from federal sources (Phase 1). The technological infrastructure of the prototype includes a Computer Assisted Telephone Interview (CATI) platform, a database consisting of patients' real time medical and treatment history, and an underlying set of intelligent algorithms that tailors the intensity of the treatment resources and approaches administered in individual cases, with a special focus on identifying those enrolled adolescents needing more intensive or urgent care. When interacting with patients over the telephone, primary care nurses use the CATI to facilitate the reliable assessment of patient status and administer manualized, empirically informed interventions. The programming for the platform that delivers this intervention is complete and the debugging and refinement underway. The content for the remaining iTAD program has been developed and is being programmed. A Rapid Iterative Evaluation & Testing (RITE) study was undertaken to refine the content of the application and assess the usability of the technology involved in its delivery; A field trial is underway to evaluate empirically indicators of efficacy and patient acceptance related to the ITEMS-TAD approach. The clinical trial of iTAD will begin in early April 2012. The investigators are currently enrolling depressed adolescents who will begin the trial shortly.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Connecticut
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Farmington, Connecticut, Estados Unidos, 06030
- University of Connecticut Health Center
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Massachusetts
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Woburn, Massachusetts, Estados Unidos, 01801
- Woburn Pediatric Associates
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Diagnosis of Major Depressive Disorder
- Age 12-17 years, inclusive, at time of first study visit
- Ability to receive care as an outpatient
- Ability to participate in at least 1 session by phone per week for approximately 12 weeks
- Ability to participate in at least 1 session by phone per week for approximately 12-16 weeks
- Ability to speak English fluently and to provide written and/or verbal feedback on the instrument and the process.
- Pediatrician impression of normal IQ for developmental level
Exclusion Criteria:
- Current or past diagnosis of: bipolar disorder, severe conduct disorder, pervasive developmental disorders, of thought disorder
- Current treatment with Cognitive Behavioral Therapy (CBT)
- Confounding medical condition (such as pregnancy, Lyme disease, etc.)
- Non-English speaking patient or parent/guardian
- No access to phones
- Dangerousness to self or others if they have been hospitalized for dangerousness within three months of consent
- Deemed to be "high risk" because of a suicide attempt requiring medical attention within 6 months of consent or clear intent or an active plan to commit suicide
- History of self-harm, suicidal attempts, or suicidal ideation
- Specialty care for substance abuse (i.e. without participation of primary care providers)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: Telephonic CBT
Computer guided, cognitive behavioral therapy (CBT) delivered by a clinician-administered telephone intervention.
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Cognitive behavioral therapy, guided by computer, using the TAD protocol for treatment of Adolescent Depression, modified for delivery by a nurse or master's level clinician over the telephone in 15-18 sessions lasting 30-45 minutes at weekly intervals.
Includes regular and standardized weekly monitoring by the treating clinician of depressive symptoms and factors affecting suicide risk.
Outros nomes:
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Comparador Falso: Wait List Control
Randomized wait list control with measurement of study outcomes at week 0, 3 and 5 after the initiation of waiting.
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Wait list control with measurement of key outcomes at baseline (week 0), and then weeks 3 and 5.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Changes in measures of depression over the course of treatment among teens with Major Depressive Disorder.
Prazo: 12 weeks
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The measure used is the PHQ-9 (Kroenke, et al.), a standard and validated measure for use in screening for or monitoring adolescent depression.
Teens that score positively on Item #9 (a self-harm risk item), will be further evaluated by the clinician using two interactive and validated methods for standardized assessment of suicide risk: a brief version of the Beck Hopelessness scale and the C-CASA (Columbia University).
Teens needing referral to a behavioral health specialist will be referred by the nurse and/or the pediatrician for further evaluation and treatment.
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12 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Evidence of program efficacy as indicate by changes in subjects' knowledge of depression.
Prazo: 12 weeks
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A Depression Knowledge Test (DKT) will be used to assess changes in the level of knowledge teens have about depression and its treatment.
The DKT consists of 10 open response questions based on materials from the TADS Adolescent Workbook.
Sample questions include "We know there are four main causes of depression.
List as many as you can," and "There are some learned patterns that people need to change to overcome depression.
List as many patterns as you can."
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12 weeks
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Evidence of program efficacy as indicated by development of self-efficacy skills.
Prazo: 12 weeks
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A Skill Self-Efficacy Questionnaire (SSEQ) will be used to assess changes in the level of self-confidence teens have in their ability to use the cognitive behavioral skills taught in the demo program.
Using the same assessment schedule as the DKT, teens will be asked to rate self-confidence in their ability to "set goals," "achieve goals," "know what they are feeling," "know how intensely they feel something," and "know what causes their feelings."
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12 weeks
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Evidence of program efficacy as indicated by the establishment of therapeutic alliance.
Prazo: 12weeks
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Therapeutic alliance between adolescents and nurse managers will be measured by the Therapeutic Alliance Scale for Adolescents (TASA; Shrink et al., 2008.
The TASA is explicitly designed to measure the strength of the therapeutic alliance among teens participating in CBT treatments.
A maximum score is 6.0 based on a Likert scale from one to six.
The list of items for this measure of therapeutic alliance indicates very high bonding between counselors and patients.
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12weeks
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Evidence of program efficacy as indicated by fidelity and treatment quality.
Prazo: 12 weeks
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The Cognitive Therapy Scale (CTR) will be used as a measure of treatment quality and fidelity of the calls by and interactions of the study nurses with the teens.
The CTR has been considered a standard measure of competence in cognitive therapy for more than 20 years,(Young JE 1980; Dobson, Shaw et al. 1985; Vallis, Shaw et al. 1986).
Recorded sessions will be rated on the scale by certified raters from the American Academy of Cognitive Therapy (ACT).
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12 weeks
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Evidence of program efficacy as indicated by program acceptance.
Prazo: 12 weeks
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An acceptance questionnaire will be administered to teens to determine their overall perception and acceptance of the program.
The questionnaire contains 9 questions, asking the subject to rate the usefulness of the program; comment on its quality, and suggest areas for improvement.
The acceptance questionnaire uses a 7-point Likert scale for rating purposes ranging from (1 = not at all to 7 = extremely).
It also includes three open-ended questions to capture what teens like the best or the least about the program, and their suggestions for improving the program.
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12 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Steven E Locke, MD, iHope Network, Inc.
- Investigador principal: Thomas J. McLaughlin, ScD, iHope Network, Inc.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- VHS 85350-02
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