Ignite Creation Date:
2024-05-05 @ 7:13 PM
Last Modification Date:
2024-10-26 @ 9:45 AM
Study NCT ID:
NCT00622271
Status:
COMPLETED
Last Update Posted:
2011-11-17
First Post:
2008-02-14
Brief Title:
Intervention Groups for Adolescents With Type 1 Diabetes Mellitus
Sponsor:
Childrens Hospital and Health System Foundation Wisconsin
Organization:
Childrens Hospital and Health System Foundation Wisconsin
Study Overview
Official Title:
Adjustment and Self-Management Intervention Groups for Adolescents With Type 1 Diabetes Mellitus and Their Parents
Status:
COMPLETED
Status Verified Date:
2011-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to utilize a group therapy adjustment and coping program at the Childrens Hospital of Wisconsin with patients who have Type 1 Diabetes Mellitus T1DM and their parents within a typical clinical condition of patients who have been referred for outpatient therapy services To extend the previous literature on these types of peer and family-based groups to include survey data as well as provider ratings medical data and add retrospective and prospective data from baseline enrollment To aid in establishing this group therapy methodology as a promising evidence-based intervention within a population of youths with T1DM and their families The specific aim of this project is to enroll patients and their families into either a treatment group or a wait list control group to receive the group intervention to determine the impact of this peer and family-based group on improving adjustment coping and functioning within diabetes
Detailed Description:
A total sample size of approximately 40 youth participants and their parents 4 x 6-10 in two waves will be recruited More specifically there will be a treatment group n 6-10 and a wait list control group n 6-10 who participate in the first wave and another treatment group n 6-10 and wait list control group n 6-10 in the second wave This number was chosen on the basis of including an adequate number of participants to appropriately demonstrate the effectiveness of the protocol within a clinical setting the recommendations to conduct group therapy in cohorts of 6-10 to be the most effective clinically and the pragmatics of participant availability based on the referral rates from the Diabetes Clinic in the past for mental health treatment In addition having 6-10 participants will allow for some participant attrition without impacting the effectiveness of the group therapy
All families with an eligible participant an adolescent between the ages of 13-17 years old with T1DM who is seen at the Childrens Hospital of Wisconsin Diabetes clinic will be recruited by diabetes providers and study researchers in the Diabetes Clinics and education classes and from referrals to the Child and Adolescent Psychiatry and Behavioral Medicine Center Clinic They will be given a flyer describing the study Families will contact the intake coordinators at the Child and Adolescent Psychiatry and Behavioral Medicine Center to receive a phone intake and be screened for appropriateness of their participation in the group therapy An insurance verification will also be completed to determine insurance coverage for participating in the group If a family is not eligible or declines to participate in the group therapy research they will be referred for individual therapy For those participants who do qualify and agree verbally to participate plans will be made for the family to participate in an intake session At that initial intake visit if they remain interested in participating in this study they will be randomly assigned to the treatment group or the WLC group per the CONSORT Guidelines Moher et al 2001 Once they have arrived for their intake appointment in the Child and Adolescent Psychiatry and Behavioral Medicine Center the parents and adolescents will be asked to give informed consentassent for both the clinical and research aspects of the group therapy They will then complete the questionnaires before their intake session In addition participants will be recruited through an advertisement in the Childrens Hospital of Wisconsin diabetes newslettersmailings as well as postings of the advertisement flyer and recruitment in the Diabetes Clinic
Following parental consent and adolescent assent the parents will complete standardized measures of general demographic information general psychosocial functioning eg quality of life emotional and behavioral functioning of their child parent stress health-related family impact and diabetes-related functioning eg adherence readiness to change behaviors responsibility health-related quality of life health satisfaction The adolescents will be asked to complete measures of general demographic information general psychosocial functioning eg quality of life and emotional and behavioral functioning and diabetes-related functioning eg adherence readiness to change behaviors responsibility health-related quality of life For the treatment group these measures will be given again at post-treatment and then at 4 months after baseline For the WLC group these measures will be given again at the initiation of group therapy post-treatment and 4 months after starting group treatment Please see attached schedule of assessments for reference The length of time to complete these questionnaires is estimated to be around 45 minutes
In addition to the self-report measures each participants medical record will be reviewed for information for the 6 months prior to baseline and the 6 months after the start of group therapy to obtain height weight Tanner scores hospital admissions related to diabetes ER visits related to T1DM outpatient diabetes clinic visits severity of diabetes ketoacidosis DKA admissions through pH and HCO3 mEqL lab work Hemoglobin A1c levels categorical ratings of diabetes status and absentee rates at school from the outpatient clinic notes during the participation time period The duration and type of diabetes reported by parents will be verified during the medical record review We will track inpatient and outpatient hospital charges for diabetes that occur in the CHW system during the participation time frame
Participants will be treated as outpatient clinic patients and will be responsible for all costs associated with care including group therapy charges Funds are not available for payment of diabetes self-management education DSME fees clinic fees lab fees hospitalization or reimbursement of participants Any medical or mental health costs outside of the clinical and research materials eg surveys copies and supplies for group therapy during the intervention will be the responsibility of the participants family or third party insurer
All families with an eligible participant an adolescent between the ages of 13-17 years old with T1DM who is seen at the Childrens Hospital of Wisconsin Diabetes clinic will be recruited by diabetes providers and study researchers in the Diabetes Clinics and education classes and from referrals to the Child and Adolescent Psychiatry and Behavioral Medicine Center Clinic They will be given a flyer describing the study Families will contact the intake coordinators at the Child and Adolescent Psychiatry and Behavioral Medicine Center to receive a phone intake and be screened for appropriateness of their participation in the group therapy An insurance verification will also be completed to determine insurance coverage for participating in the group If a family is not eligible or declines to participate in the group therapy research they will be referred for individual therapy For those participants who do qualify and agree verbally to participate plans will be made for the family to participate in an intake session At that initial intake visit if they remain interested in participating in this study they will be randomly assigned to the treatment group or the WLC group per the CONSORT Guidelines Moher et al 2001 Once they have arrived for their intake appointment in the Child and Adolescent Psychiatry and Behavioral Medicine Center the parents and adolescents will be asked to give informed consentassent for both the clinical and research aspects of the group therapy They will then complete the questionnaires before their intake session In addition participants will be recruited through an advertisement in the Childrens Hospital of Wisconsin diabetes newslettersmailings as well as postings of the advertisement flyer and recruitment in the Diabetes Clinic
Following parental consent and adolescent assent the parents will complete standardized measures of general demographic information general psychosocial functioning eg quality of life emotional and behavioral functioning of their child parent stress health-related family impact and diabetes-related functioning eg adherence readiness to change behaviors responsibility health-related quality of life health satisfaction The adolescents will be asked to complete measures of general demographic information general psychosocial functioning eg quality of life and emotional and behavioral functioning and diabetes-related functioning eg adherence readiness to change behaviors responsibility health-related quality of life For the treatment group these measures will be given again at post-treatment and then at 4 months after baseline For the WLC group these measures will be given again at the initiation of group therapy post-treatment and 4 months after starting group treatment Please see attached schedule of assessments for reference The length of time to complete these questionnaires is estimated to be around 45 minutes
In addition to the self-report measures each participants medical record will be reviewed for information for the 6 months prior to baseline and the 6 months after the start of group therapy to obtain height weight Tanner scores hospital admissions related to diabetes ER visits related to T1DM outpatient diabetes clinic visits severity of diabetes ketoacidosis DKA admissions through pH and HCO3 mEqL lab work Hemoglobin A1c levels categorical ratings of diabetes status and absentee rates at school from the outpatient clinic notes during the participation time period The duration and type of diabetes reported by parents will be verified during the medical record review We will track inpatient and outpatient hospital charges for diabetes that occur in the CHW system during the participation time frame
Participants will be treated as outpatient clinic patients and will be responsible for all costs associated with care including group therapy charges Funds are not available for payment of diabetes self-management education DSME fees clinic fees lab fees hospitalization or reimbursement of participants Any medical or mental health costs outside of the clinical and research materials eg surveys copies and supplies for group therapy during the intervention will be the responsibility of the participants family or third party insurer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None