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Parent-Provider Intervention for Improving Medication Adherence in Children With Attention Deficit Hyperactivity Disorder

22 avril 2013 mis à jour par: New York State Psychiatric Institute

ADHD Medication Adherence: A Parent-Provider Intervention Modeled From HIV

This three-phase study will develop and test a provider-administered intervention to improve medication adherence and promote sustained medication use among children with ADHD and their caregivers.

Aperçu de l'étude

Description détaillée

Attention deficit hyperactivity disorder (ADHD) is a common childhood behavior disorder that causes impaired functioning in multiple settings, including home, school, and in relationships with peers. Symptoms of ADHD include impulsiveness, hyperactivity, and inattention. Both medications and behavior therapies have been shown to be effective in treating ADHD. It is essential, however, that children take their medication regularly for it to be effective. This three-phase study will develop and test a provider-administered intervention to improve medication adherence and persistence among children with ADHD and their caregivers.

The first phase of this study will gather information about perspectives on ADHD and its treatment by using focus groups and interviews with participating children and their parents. Phase two of the study will gather information on medication adherence and persistence, as well as demographic information. Phase three of the study will involve developing and testing a three part intervention consisting of an ADHD education component, a short survey to help parents identify non-adherence warning signs, and tailored medication messages for parents. After conducting a pilot with five parent-child pairs to assess feasibility and accessibility, all interested doctors at the study site will receive a lecture on evidence-based treatments for ADHD and a supply of parent ADHD education toolkits. Half of the doctors will be randomly assigned to receive additional training on the experimental procedures and to administer the intervention as part of the study. Parent and child participants will be randomly assigned to receive either treatment with a doctor who has been trained on the experimental intervention or treatment as usual. Assessments will take place at the beginning of treatment and 1, 3, and 6 months after the start of treatment. During each assessment, a saliva sample will be collected from the child, and parents will complete several checklists and questionnaires about ADHD treatment and medication adherence.

Type d'étude

Interventionnel

Phase

  • N'est pas applicable

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

6 ans et plus (Enfant, Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

PHASE I:

Inclusion Criteria:

Parent Focus Group Participants:

  • Must be primary caregiver and legal guardian of child (6-10 years) at time of initial ADHD diagnosis
  • Child must have been diagnosed with ADHD within the last 18 months at Schneider Children's Hospital's (SCH) outpatient clinic (co-morbid diagnosis of oppositional defiant disorder [ODD] or conduct disorder [CD] is permitted)

Provider Focus Group Participants:

  • Child psychiatrist employed by North Shore - Long Island Jewish child psychiatry outpatient department
  • Licensed to practice in New York State
  • Has more than 1 year of experience prescribing medication to youth with ADHD

Child Interview Participants:

  • Diagnosis of ADHD (co-morbid diagnosis of ODD, CD, or mood disorder is permitted)
  • Between 6 and 10 years old at time of initial ADHD diagnosis
  • Diagnosis occurred within 18 months prior to study entry at Zucker Hillside Hospital outpatient clinic

Exclusion Criteria:

Parent Focus Group Participants and Child Interview Participants:

  • Child has significant co-morbid medical conditions, such as diabetes, cystic fibrosis, or severe asthma, resulting in more than 2 emergency visits in the last year
  • Child has a co-morbid diagnosis of psychosis, bipolar disorder, or other serious psychiatric condition within 12 months prior to study entry
  • Child has history of psychiatric hospitalization within 12 months prior to study entry
  • Child is receiving treatment in a different setting

PHASE II:

Inclusion Criteria:

  • Primary caregiver and legal guardian of child (6-10 years) at the time of initial ADHD diagnosis
  • Child has been diagnosed with ADHD within the last 18 months at SCH's outpatient clinic

Exclusion Criteria:

  • Parents of children with co-morbid medical conditions other than oppositional defiant disorder (ODD) or conduct disorder (CD)
  • Parents of children with a co-morbid diagnosis of psychosis, bipolar disorder, mental retardation, or other severe mental illness, evidence of mental retardation, or history of psychiatric hospitalization within 12 months prior to study entry
  • Child is receiving treatment in a different setting

PHASE III:

Inclusion Criteria:

  • Medication naïve children with a primary diagnosis of ADHD (co-morbid ODD will be permitted) at the Child Psychiatric Outpatient Department at SCH
  • Parents are the legal guardians
  • Both parents and children willing to sign the informed consent/assent

Exclusion Criteria:

  • Children with co-morbid medical conditions other than ODD
  • Children with a co-morbid diagnosis of psychosis, bipolar disorder, or other serious psychiatric condition, evidence of mental retardation, or history of recent hospitalization

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Parents' attitudes and beliefs
Parents' reported adherence, prescription refill, and side effect information
Children's adherence (all measured at Months 1, 3, and 6)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Elizabeth A. Pappadopulos, PhD, Columbia University/New York State Psychiatric Institute

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 janvier 2006

Dates d'inscription aux études

Première soumission

30 janvier 2007

Première soumission répondant aux critères de contrôle qualité

30 janvier 2007

Première publication (Estimation)

31 janvier 2007

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

23 avril 2013

Dernière mise à jour soumise répondant aux critères de contrôle qualité

22 avril 2013

Dernière vérification

1 avril 2013

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • #5327
  • DAHBR 96-BHA (UTHSCSA)
  • R34MH078700 (Subvention/contrat des NIH des États-Unis)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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