Completado

Pilot Study to Extend the K-SADS-PL to Adolescents and Young Adults

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Qué se está recopilando

Colección de datos

Recopilados desde hoy en adelante - Prospectivo
Quiénes están siendo reclutados

Trastornos de Ansiedad

+ Trastornos Mentales

+ Neoplasias

De 18 a 80 años
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Cómo está diseñado el estudio

Cohorte

Seguimiento de la incidencia de una enfermedad para identificar factores de riesgo y comprender su progresión a lo largo del tiempo.
Observacional
Inicio del estudio: enero de 2013
Ver detalles del protocolo

Resumen

Patrocinador PrincipalNational Institute of Mental Health (NIMH)
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 26 de enero de 2013

Fecha en la que se inscribió al primer participante.

Objective: The goal of this pilot project is to describe the feasibility of using the Schedule for Affective Disorders and Schizophreni\\a for School Age Children Present and Lifetime Version (K-SADS-PL) to screen and evaluate older adolescents and young adults (ages 18-25) for mood and anxiety disorders. An additional aim is to describe the contribution of the parent interview portion of the instrument for this age group. Two groups of 18-25 year old participants will be enrolled: healthy volunteers and patients with cancer. The information gained in this pilot study will inform the design of future intervention studies that target mood and anxiety disorders among pediatric oncology patients. Primary aim: Aim 1: Feasibility - Describe the feasibility of using the K-SADS-PL interview to screen and evaluate for mood and anxiety disorders among two groups of 18 25 year olds (healthy volunteers and patients with cancer) and their parents. Hypothesis 1: The K-SADS-PL interview is feasible to use in the two groups of 18 25 year olds; the feasibility of completing the parent portion of the K-SADS-PL will be better among parents of cancer participants compared to parents of healthy volunteers. Secondary aim: Aim 2: K-SADS-PL outcomes - Compare and contrast K-SADS-PL findings based on responses provided by participants versus summary ratings that take into account both parent and child responses. Hypothesis 2: Summary ratings of K-SADS-PL screening and diagnostic questions will yield more positive screening findings (subthreshold or threshold) compared to participant ratings alone. Study population This pilot study will include a convenience sample of young adults, aged 18-25, from two groups healthy volunteers and individuals who are participants in oncology protocols at the NIH Clinical Center (inpatient or outpatient) and who agree to participate. Participants may be from any institute, but must have a parent who will agree to be interviewed. Design This is a pilot study to describe the feasibility of extending the K-SADS-PL diagnostic interview to screen and evaluate young adults 18-25 years of age for psychiatric disorders. Informed consent will be obtained from the participant and his/her parent. The interview will be administered by a interviewer trained to administer the K-SADS-PL instrument. The same interviewer will administer the K-SADS-PLL to both the participant and the parent. The participant will be interviewed first, and the parent second. If there is more than one parent who is eligible, the parent who knows the participant best will be chosen. All interviews will be recorded. A subset of interview recordings will be randomly rated by a gold standard expert rater to determine inter-rater kappa coefficients for screening and diagnostic questions about mood and anxiety disorders. Availability of parents to complete the K-SADS-PL interview will be optimized by allowing either face-to-face or phone interviews. If a parent interview reveals clinically significant information that the participant did not report, the interviewer will re-contact the participant to complete the necessary diagnostic module. Summary screening and diagnostic ratings will be determined by the interviewer, taking into account both participant and parent responses as per the K-SADS-PL design. We will also ask participants to complete several short questionnaires:1) Hospital Anxiety and Depression Scale (HADS); 2) Parent-child frequency of contact; 3) Distress Thermometer; 4) Course of Life questionnaire.

Título OficialPilot Study to Extend the K-SADS-PL to Adolescents and Young Adults
NCT01778478
Patrocinador PrincipalNational Institute of Mental Health (NIMH)
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

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Detalles del Diseño

Se reclutarán 50 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Cohorte

Estos estudios siguen a un grupo de personas con características comunes (como una condición o año de nacimiento) durante un periodo específico para analizar resultados de salud o exposiciones.

Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

De 18 a 80 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Trastornos de AnsiedadTrastornos MentalesNeoplasias

Criterios

* a. Description of proband patients and healthy volunteers: these adult participants between the ages of 18-25 will be invited to undergo a psychiatric diagnostic interview using the K-SADS PL. Current or past history of mental health problems or treatment is allowed. b. Proband patient/healthy volunteer inclusion criteria * Age 18-25 years, males and females * English speaking * Participant has contact (face-to-face, phone or electronic) with at least one of his/her parents at least once per week * Enrolled in an NIH CC study (probands) or in good general health (healthy volunteers) c. Proband patient/healthy volunteer exclusion criteria * Unable to provide informed consent * Known severe intellectual disability such as a history of mental retardation, pervasive developmental disorder or inability to complete an 8th grade education. * Initial cancer diagnosis within the past 3 months. * Current unstable medical condition as evidenced by Karnofsky score below 50 (for cancer patients) * Refusal to be video or audio recorded * Cancer that involves the brain either as primary site of cancer or as a result of metastatic disease. d. Description of parent participants: If there is more than one parent who is eligible, the parent who knows the participant best will be chosen. For this study, we define parent as a primary caregiver during the participant s early life who directly observed the child s development and is still alive to be interviewed. This could allow for informants who are adoptive parents or other close relatives who raised the child. e. Parent participant inclusion criteria * English speaking * Parent of a patient proband or healthy volunteer enrolled in the study * Parent has contact (face-to-face, phone or electronic) with his/her child at least once per week f. Parent participant exclusion criteria * Unable to provide informed consent * Known severe intellectual disability such as a history of mental retardation, pervasive developmental disorder or inability to complete an 8th grade education. * Refusal to be video or audio recorded

Plan de Estudio

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Objetivos del Estudio

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

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Suspendido

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, United StatesAbrir National Institutes of Health Clinical Center, 9000 Rockville Pike en Google Maps
Completado1 Centros de Estudio