Computerized Intervention of Parental Involvement in Diabetes Care of Their Child
1 juin 2017 mis à jour par: Deborah Ellis, Ph.D., Wayne State University
Computer-Delivered Motivational Intervention to Improve Teen Diabetes Management
The purpose of this study is to develop an intervention to increase parental motivation for supervision and monitoring youth diabetes care behavior.
The intervention will be tested in three brief session in conjunction with regularly scheduled diabetes clinic visits and delivered through a computer program based in the principles of Motivational Interviewing.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
The study includes a development phase (Phase 1: development of the intervention followed by feasibility testing with 10 youth and 10 parents) and a pilot validation phase [Phase 2: pilot randomized clinical trial (RCT)] using a sample of 90 African American youth transitioning to independent diabetes care and their parents.
In this phase, families will be randomly assigned to one of three study arms: parent motivation for monitoring and youth motivation for diabetes care (arm 1), parent motivation for monitoring and youth information (arm 2) or parent and youth information (arm 3).
In phase 1 (development), youth and their caregivers will complete a one-time research visit where they use the program and provide feedback via a semi-structured interview regarding the usefulness of the content, its user-friendliness and make suggestions for changes to enhance acceptability.
In phase 2 ( RCT), families will complete three intervention plus data collection visits and one additional data collection only visit.
Research visits will be scheduled to coincide with appointments in the diabetes clinic to maximize convenience for families.
Type d'étude
Interventionnel
Inscription (Réel)
145
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
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Michigan
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Detroit, Michigan, États-Unis, 48201
- Wayne State University
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-
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
10 ans à 13 ans (Enfant)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- African American race/ethnicity
- Age: 10 years 0 months - 12 years, 11 months
- Type 1 diabetes mellitus
- Diagnosed at least 6 months
- Patient of Children's Hospital of Michigan Diabetes Clinics
- English fluency, both verbal and written
Exclusion Criteria:
- Psychiatry/psychological diagnoses including cognitive impairment that would prevent the participant from understanding the data collection measures, (i.e. moderate or severe mental retardation) or the following psychiatric diagnoses: autism and schizophrenia. Youth with current suicidal intent are not enrolled until psychiatrically stable.
- Medical diagnoses that would result in atypical diabetes management i.e. cystic fibrosis. Other medical conditions that would not affect diabetes management, such as asthma, do not exclude the participant from study participation.
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
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Active Caregiver and Active Child
Parent & Child Computer-Delivered Motivational Intervention will be delivered to participants.
A brief computer delivered behavior change counseling intervention for parents of children with diabetes to improve monitoring of diabetes care and a brief computer delivered behavior change counseling intervention for children with diabetes to improve completion of daily diabetes care.
|
Motivational Interviewing (MI) is a client-centered, directive method for enhancing intrinsic motivation to change by exploring & resolving ambivalence, with a strong evidence for improving adolescent & adult health behaviors.
Three motivational sessions will be provided by an animated character who delivers the intervention with high fidelity to MI principles.
Small amounts of psychoeducation about potential improvements illness management that can result from monitoring/completing diabetes care will be integrated with more purely motivational elements.
Mailings will be sent to participants to remind them of the reasons they gave as motivation & goals they set regarding diabetes care.
|
|
Expérimental: Active Caregiver and Child Education
Parent Computer-Delivered Motivational Intervention will be delivered to the parents only.
A brief computer delivered behavior change counseling intervention for parents of children with diabetes to improve monitoring of diabetes care and a brief computer delivered informational session about diabetes related topics for their child with diabetes.
|
Motivational Interviewing (MI) is a client-centered, directive method for enhancing intrinsic motivation to change by exploring & resolving ambivalence, with a strong evidence for improving adolescent & adult health behaviors.
Three motivational sessions will be provided by an animated character who delivers the intervention with high fidelity to MI principles.
Small amounts of psychoeducation about potential improvements illness management that can result from parental monitoring of diabetes care will be integrated with more purely motivational elements.
Mailings will be sent to participants to remind them of the reasons they gave as motivation & goals they set regarding monitoring diabetes care.
|
|
Comparateur actif: Education Caregiver/Education Child
Participants will receive computer-delivered information.
A brief computer delivered information session about diabetes related topics for both the caregiver and the child with diabetes.
|
Computer-Delivered Information about issues related to living with diabetes that do not directly impact completing diabetes care.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Diabetes Management Scale
Délai: Each of 3 intervention session, 3-4 month apart
|
The Diabetes Management Scale (DMS) (Frey, Ellis, Naar-King et al., 2004) is a self-report questionnaire used to measure a broad range of diabetes management behaviors, such as insulin management, dietary management, blood glucose monitoring, symptom response, and parent assistance/supervision.
|
Each of 3 intervention session, 3-4 month apart
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Treatment Regulation Questionnaire
Délai: Each of 3 intervention session, 3-4 month apart
|
Parental motivation to monitor the youth is measured by the Treatment Self-Regulation Questionnaire (TSRQ; Ryan & Connell (1989).
The TSRQ evaluates why people engage in a health-relevant behavior and assesses the degree to which one's motivation for a particular behavior or set of behaviors is relatively autonomous or self-determined as compared to derived from external pressures or constraints.
|
Each of 3 intervention session, 3-4 month apart
|
|
Readiness Ruler
Délai: Each of 3 intervention session, 3-4 month apart
|
Parent motivation to monitor the youth is also measured by the Readiness Ruler (Stott, Rollnick, & Pill, 1995).
Since readiness to change behaviors is behavior specific, the items will be tailored to assess the behaviors most critical to parental monitoring of diabetes management.
The response format is a visual analog scale (VAS) 10 mm in length.
Written cues anchor the ends and middle of the scale.
Respondents mark their "readiness" on the scale and the position on the line is measured in millimeters.
|
Each of 3 intervention session, 3-4 month apart
|
|
HbA1C Blood Test
Délai: Each of 3 intervention session, 3-4 month apart
|
Metabolic control will be measured via hemoglobin A1c (HbA1c).
HbA1c is an indirect and retrospective measure of average blood glucose levels over the previous two to three month period.
|
Each of 3 intervention session, 3-4 month apart
|
|
Parental Monitoring of Diabetes Care
Délai: Each of 3 intervention session, 3-4 month apart
|
The Parental Monitoring of Diabetes Care scale (PMDC) is an 18 item, investigator-developed questionnaire that measures the frequency of parental monitoring and direct supervision of diabetes care tasks such as insulin administration, blood glucose testing, and dietary management.
|
Each of 3 intervention session, 3-4 month apart
|
|
Twenty-four Hour Recall Interview
Délai: Each of 3 intervention session, 3-4 month apart
|
The Twenty-four Hour Recall Interview, developed by Johnson and colleagues (Freund, Johnson, Silverstein et al., 1991), has been used extensively in pediatric diabetes research for the assessment of illness management.
|
Each of 3 intervention session, 3-4 month apart
|
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Blood Glucose Testing Frequency
Délai: Each of 3 intervention session, 3-4 month apart
|
Objective data on mean daily frequency of blood glucose testing during the 14-day period prior to data collection will be obtained directly from blood glucose meters.
|
Each of 3 intervention session, 3-4 month apart
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Deborah A Ellis, Ph.D., Wayne State University
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 avril 2011
Achèvement primaire (Réel)
3 mars 2014
Achèvement de l'étude (Réel)
9 septembre 2014
Dates d'inscription aux études
Première soumission
18 janvier 2012
Première soumission répondant aux critères de contrôle qualité
23 janvier 2012
Première publication (Estimation)
24 janvier 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
2 juin 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
1 juin 2017
Dernière vérification
1 juin 2017
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 3M's Diabetes Study
- R21DK089238 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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