D'SNAPPParent Training for Preschool ADHD: A Randomised Controlled, Multicentre Effectiveness Trial of the New Forest Parenting Programme in a Clinical Sample of Danish Children
New Forest Parenting Programme
+ Treatment as usual
Troubles Mentaux+1
+ Troubles du déficit de l'attention et du comportement perturbateur
+ Troubles du développement neurologique
Étude thérapeutique
Résumé
Date de début de l'étude : 1 septembre 2012
Date à laquelle le premier participant a commencé l'étude.Description: A study to: 1) Address the need for non-pharmacological treatment in young children with ADHD and 2) Address the need for the development of evidence-based psychosocial treatment interventions in Danish child mental health services, through the implementation of the New Forest Parenting Programme (NFPP). Rationale: ADHD is a neuro-developmental disorder with symptoms frequently occurring in early childhood. ADHD is associated with long-term personal, psychosocial sequalae. ADHD presents a considerable societal cost burden, both for mental health services, but also in areas such as education, employment, the criminal justice system. Pharmacological treatment of preschool ADHD is not recommended as first-line treatment, due to a number of reasons, including lack of evidence for efficacy, parental concerns, side effects on growth rates, and the unknown long-term implications for the developing brain. Effective psychosocial treatments for ADHD are therefore of central public priority generally, and for child mental health services, specifically. Currently, psychosocial interventions for ADHD in pre-school children in Danish Child and Adolescent Mental Health Services (CAMHS) are not well described or systematically developed. There is a pressing need to develop evidence-based psycho-social treatments for young children with ADHD in Danish CAMHS. Design: The study will be a randomised controlled multi-centre effectiveness trial comparing NFPP intervention to a Treatment as Usual control group. The trial will recruit 200 preschool children (aged 3-6) with a diagnosis of ADHD from two Danish outpatient child mental health service sites. Participants will be randomised to either 1) NFPP over a period of 8 weeks or 2) a control group receiving Treatment as Usual (TAU). Outcome: The primary outcome measure will be child ADHD symptoms. Secondary outcomes include parental wellbeing, child quality of life, parent-child interactions. Measures will be collected at three time points to track changes in outcome: T1: Before start of intervention or TAU condition. T2: Directly after the intervention or TAU and T3: 6 month follow-up after T1 for both arms of the trial. The study will perform exploratory moderator and mediator analyses. Expertise: The study receives external consultation from an international expert team for the planning, execution, NFPP training and supervision. The team consists of research and clinical experts in the treatment and evaluation of interventions for preschool ADHD.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.164 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 3 à 7 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalGroupe II
Objectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Center for child and adolescent psychiatry
Risskov, DenmarkOuvrir Center for child and adolescent psychiatry dans Google Maps