Terapia cognitivo-conductual impartida por Internet para adolescentes con autismo y ansiedad (LUNA-A)
Terapia cognitivo-conductual impartida por Internet para adolescentes con autismo y ansiedad: desarrollo y evaluación del aprendizaje para comprender y navegar la ansiedad en adolescentes
Anxiety is very common in autistic youth. Cognitive behavioral therapy (CBT) is the recommended treatment for both autistic and typically-developing (TD) youth with anxiety, yet most families cannot access CBT due to cost, practicalities of attending in-person treatment sessions, and a shortage of trained providers, especially in rural areas. The goal of this project is to increase access to care for families of autistic adolescents with anxiety through an internet-based treatment model.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Autism affects 2-3% of youth, approximately half of whom experience a co-occurring anxiety disorder. Anxiety disorders in autistic youth are associated with significant life impairment and worsening trajectory without treatment. Cognitive behavioral therapy (CBT) is the recommended treatment for both autistic and typically-developing (TD) youth with anxiety, yet most families cannot access CBT due to cost, practicalities of attending in-person treatment sessions, and a shortage of trained providers, especially in rural areas. Access to CBT is particularly limited for Hispanic or Spanish-speaking families due to lack of services provided in Spanish. Internet-delivered therapies such as iCBT provide low intensity but effective intervention and overcomes barriers such as cost, travel, time from work/school, and stigma. Studies suggest that iCBT protocols for anxious typically-developing youth demonstrate moderate to strong effect sizes relative to control groups. However, until recently, such treatment models have not been developed with stakeholder engagement to be personalized for autistic children with anxiety and their families, including for those families that speak Spanish. In a previous Texas Higher Education Coordinating Board (THECB) funded work, a parent-led iCBT intervention for anxiety among autistic youth, Learning to Understand and Navigate Anxiety (LUNA) was developed. Over 60% of participants demonstrated response to treatment, yet children responded better than adolescents. Family feedback indicated that the materials were not developmentally appropriate for adolescents, necessitating further efforts to develop and evaluate an adapted version which is personalized to the unique needs of autistic adolescents with anxiety. The goal of this project is to increase access to care for families of autistic adolescents with anxiety through an internet-based treatment model (LUNA-Adolescent). This treatment model, developed by the study team, consists of an interactive website with both parent- and adolescent-facing treatment materials, supported by brief therapist contact (e.g. telehealth sessions), both in English and Spanish. Specifically, this project will evaluate the efficacy and cost effectiveness of LUNA-Adolescent compared to standard-care CBT for anxiety. Overall, this study will provide important information regarding the potential benefits of internet-based, parent-led interventions for autistic adolescents with anxiety and its two different delivery models.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Texas
-
Houston, Texas, Estados Unidos, 77030
- Baylor College of Medicine
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- The child is between the age of 11-17 years old at enrollment.
- The child is diagnosed with autism using a validated assessment (e.g., Autism Diagnostic Observation Schedule-Second Edition (ADOS-2), Childhood Autism Rating Scale-Second Edition (CARS-2), etc.).
- The child has current, clinically significant anxiety and/or OCD as indicated by a clinician-administered standardized assessment (e.g. Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) and Pediatric Rating Anxiety Scale modified for autism (PARS-ASD)).
- Anxiety disorder is the child's primary/co-primary psychiatric diagnosis, and if secondary psychopathology is present, it will not interfere with treatment.
- One parent/guardian over the age of 18 is able and willing to participate in assessment and treatment (e.g. has sufficient English/Spanish fluency, the decisional capacity to participate, and can commit to treatment duration).
- The child is able to communicate verbally.
- Participants are located in Texas.
- The participant has an IQ above 69, based on the Kaufman Brief Intelligence Test-Second Edition (KBIT-2), another valid test or clinician judgement (e.g., a previous assessment conducted, and report shared with study team)
Exclusion Criteria:
- The child has a diagnosis of a lifetime psychotic disorder and/or conduct disorder.
- The child has significant, current suicidal/homicidal ideation and/or self-injury requiring medical intervention.
- The child has limited verbal communication abilities (e.g., no independent verbal communication),
- The child is receiving concurrent psychotherapy (including certain forms of social skills training, or behavioral interventions that target anxiety such as applied behavioral analysis).
- The child has initiated new antidepressant medication within 12-weeks of assessment (4-weeks for stimulants/benzodiazepines/antipsychotics) or during therapy.
- The child has changed psychotropic medication dosage within 4-weeks of assessment (2-weeks for stimulants/benzodiazepines/antipsychotics) or during therapy.
- The child requires a higher level than can be provided through the study (e.g., significant, current suicidal ideation)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: LUNA-Adolescent
Dyads in the Learning to Understand and Navigate Anxiety-Adolescent (LUNA-Adolescent) group will receive internet-based cognitive behavioral therapy (LUNA-Adolescent), which includes 12 weekly treatment modules, 6 bi-weekly, 30-minutes telehealth visits, and email check-ins. |
Learning to Understand and Navigate Anxiety-Adolescent (LUNA-Adolescent) includes parent-led, internet-based cognitive behavioral therapy (CBT) for anxiety among autistic youth.
Otros nombres:
|
|
Comparador de placebos: Treatment as Usual
Dyads in the standard-care cognitive behavioral therapy (CBT) group will receive 12 weekly sessions of transdiagnostic CBT for anxiety in autistic youth. |
Treatment as Usual includes 12 weekly sessions of transdiagnostic cognitive behavioral therapy (CBT) for anxiety in autistic youth. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pediatric Anxiety Rating Scale modified for ASD (PARS-ASD)
Periodo de tiempo: Baseline (before treatment), during treatment (on average 6 weeks), post-treatment (on average 12 weeks), 1 month follow up
|
Clinician-rated child anxiety severity throughout the past week. Each item is scored on a 0 to 5 scale (higher scores correspond to greater severity), yielding a total between 0 and 35. This measure has been modified for autistic youth |
Baseline (before treatment), during treatment (on average 6 weeks), post-treatment (on average 12 weeks), 1 month follow up
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Clinical Global Impression-Improvement (CGI-I)
Periodo de tiempo: during treatment (on average 6 weeks), post-treatment (on average 12 weeks), 1 month follow up
|
Clinician-rated child psychopathology severity rating. A single item is scored 0-6 (0= very much improved; 6= very much worse). |
during treatment (on average 6 weeks), post-treatment (on average 12 weeks), 1 month follow up
|
|
Screen for Child Anxiety Related Disorders (SCARED)
Periodo de tiempo: Baseline (before treatment), post-treatment (on average 12 weeks), 1 month follow up
|
Parent and child self-report measure assessing anxiety symptoms including subscales for separation anxiety disorder, generalized anxiety disorder, social anxiety disorder, panic disorder or significant somatic symptoms, and significant school avoidance. A single item is scored on a 3 point Likert scale ranging from 0 (not true or hardly ever true) to 2 (very true or often true). |
Baseline (before treatment), post-treatment (on average 12 weeks), 1 month follow up
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Eric Storch, PhD, Baylor College of Medicine
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- H-55617
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .