ADHDThe Effects of a Peer Co-led Educational Programme for Parents of Children With ADHD: A Feasibility Randomized Controlled Trial
Peer co-led educational group
+ Comparator treatment as usual
Trastorno por Déficit de Atención con Hiperactividad
+ Trastornos Mentales
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de marzo de 2022
Fecha en la que se inscribió al primer participante.The primary objective of this trial is to evaluate the acceptability and feasibility of the intervention, to assure that procedures are adequate for a subsequent full size randomized controlled trial (RCT), and to determine the likely size of the trial comparing an ADHD specific parenting peer co-led intervention for parents of children with ADHD symptoms. Specific objectives are: (I) investigate whether parents of children recently diagnosed with ADHD are willing to be randomized to the intervention, (II) whether sufficient numbers of families can be recruited and retained such that a full-scale RCT is likely to be feasible, (III) whether research procedures and efficacy measures are feasible and acceptable to participating families and the outpatient clinics, and (IV) whether families participating in the intervention are satisfied with the intervention. This feasibility study is not designed to detect a treatment effect, therefore a maximum of 50 parents will be recruited. The measurements will be taken in the children (at baseline and 3 months) and parents (at baseline, two weeks, pre-post intervention and 3 months follow-up) to determine the feasibility and acceptability. These measures are chosen because they address key components of the intervention (activation, quality of life and psychological well-being). Multiple measures of similar constructs will be administered where possible (e.g., psychological well-being and quality of life) to determine which measure to include in the definitive trial according to feasibility, acceptability, and sensitivity. Feasibility assessments: * Feasibility of recruitment. * Acceptability of randomization and procedures will be determined by measuring loss to follow-up (post-test and 3-month follow-up), and reasons for withdrawal will be used collected. * Acceptability of the intervention will be determined based on the number of sessions attended by participants in the peer co-led education. We will also reported on satisfaction with the program. * Feasibility of quantitative measures will be deemed acceptable if no questionnaires are missing in full in more than 25% of the participants and if reliability was higher than 0.70. * Follow-up response rates (post-intervention and 3 months follow-ups).
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 6 a 12 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
Criterios
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
Objetivos del Estudio
Objetivos Primarios
Objetivos Secundarios