Ignite Creation Date:
2024-05-06 @ 12:06 AM
Last Modification Date:
2024-10-26 @ 10:44 AM
Study NCT ID:
NCT01490619
Status:
COMPLETED
Last Update Posted:
2020-01-27
First Post:
2011-12-07
Brief Title:
Resilience Promotion in Teens With Type 1 Diabetes Preventing Negative Outcomes
Sponsor:
Ann Robert H Lurie Childrens Hospital of Chicago
Organization:
Ann Robert H Lurie Childrens Hospital of Chicago
Study Overview
Official Title:
Resilience Promotion in Teens With Type 1 Diabetes Preventing Negative Outcomes
Status:
COMPLETED
Status Verified Date:
2020-01
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:
Adolescents with type 1 diabetes are at increased risk for depressive symptoms poor coping and problem-solving skills poor regimen adherence and negative diabetes-specific health outcomes Although a handful of psychological interventions targeting adolescents poor behavioral and emotional functioning demonstrate beneficial effects on disease management and outcomes no prevention programs exist that equip adolescents with behavioral skills and cognitive strategies necessary to reduce these risks Therefore the proposed research will test whether a diabetes-specific adaptation of a resilience promoting depression-prevention intervention for adolescents with type 1 diabetes will reduce both the risk of poor psychological functioning and the risk of negative health outcomes over time
Detailed Description:
1 Scope of Problem Adolescents with type 1 diabetes T1D must balance a complex daily treatment regimen while also facing the emotional social and academic demands of this developmental period Not surprisingly adolescents are at increased risk for anxiety and depressive symptoms poor coping and problem-solving skills poor regimen adherence and negative diabetes-specific health outcomes The mental and physical health risks of T1D add to its already staggering economic burden the annual cost of diabetes in the United States for direct medical care exceeds 116 billion and individuals with diabetes have twice the healthcare costs of their peers without diabetes
A handful of psychological interventions targeting adolescents poor behavioral and emotional functioning demonstrate beneficial effects on disease management and outcomes However no prevention programs exist that equip adolescents with behavioral skills and cognitive strategies shown to reduce both the risk of poor psychological functioning and the risk of negative health outcomes over time Although none of the effective prevention programs developed for healthy youth have been adapted for adolescents with T1D the Penn Resilience Program PRP is a viable candidate because it is a well-established prevention program shown to promote resilience and prevent depression The current study will test a diabetes-specific adaptation of PRP for adolescents with T1D and fill a significant gap in the scientific literature
This studys significance lies not only in its focus on preventing depression a prevalent critical factor influencing diabetes-specific health outcomes but also in its emphasis on ultimately preventing suboptimal glycemic control a common expensive and dangerous problem in pediatric diabetes Individuals with both depression and diabetes incur 45 times the health care costs as those with diabetes alone The focus of the intervention on resilience promotion is innovative because of its potential to fundamentally change risk for depression and set adolescents on a trajectory toward improved adherence and health outcomes Moreover documenting the mechanisms of change that impact critical psychosocial and health outcomes in youth with T1D via a longitudinal randomized controlled design facilitates generalizability to other chronically ill populations given similar management demands on the individual and family and associations with depression
2 Summary of Procedures Investigators will employ a randomized controlled design and compare PRP T1D to a diabetes education intervention EI developed by two CDEs specifically focused on adolescent learning and adolescent needs on resilience characteristics depressive symptoms adherence behaviors and glycemic outcomes Investigators will recruit 280 adolescents with T1D across two cities Chicago and Cincinnati measuring outcomes at baseline post-intervention and at five surveillance visits spanning an additional 24 months All adolescents will participate in 9 sessions lasting approximately 90 minutes each session Assessments occur at baseline 0 months post-intervention 45 months and during the surveillance period 8 12 16 and 28 months
PRP T1D will be led by masters level graduate students enrolled in clinical psychology PhD programs EI will be led by CDE nurses This EI group is preferable to either untreated control or wait-list control groups as it allows for the experimental control of attention peer group sessions and dose on treatment outcomes Both program leaders will receive over 20 hours of training in the program they are leading
Data Collection and Measures Measures assess two primary outcomes depressive symptoms and glycemic control and two mechanisms of change resilience and adherence Assessments occur at baseline post-intervention 45 months and 4 surveillance visits 8 12 16 and 28 months To keep participant burden at a manageable level and to increase retention rate all eligible families will be invited to complete the questionnaires on a secured web-site that they can access while with the research study staff or while at home work in a public library or while in clinic Investigators will use the SNAP Survey Software system which allows for electronic completion of surveys with data directly transferred to data management software in a HIPAA-protected framework The SNAP software eliminates the need for manual data entry reducing the risk of missing data as well as reducing the risk of violating the confidentiality of the data
Hemoglobin A1c will be collected via a small sample of blood and sent to a central laboratory The Diabetes Diagnostic Laboratory at the University of Missouri httpwwwdiabetesmissourieduwill be used This laboratory served as the reference laboratory for the DCCT and NHANES III and IV studies They have extensive experience serving as a central laboratory for A1c values
Continuous glucose monitoring CGM iPro sensor and transmitter by Medtronic will assess glycemic variability The certified diabetes educator CDE or study physician will assist each participant with the insertion and calibration of the device For this study adolescents will be blinded to the CGM values for safety reasons we do not want participants adjusting insulin levels or dietary intake based on sensor readings Adolescents will wear the sensor and transmitter for 3 days After use the sensortransmitter will be collected by the research team via a pre-paid mailing container Once the transmitter is returned the data are downloaded to study computers typically with 290 values per day Investigators then calculate three indicators of glycemic variability SD of the mean of the sensor values mean amplitude of glycemic excursions MAGE and percentage of time spent within glucose ranges The amount of time spent within target values between 70 and 180 below target values below 70 and above target values above 180 will be calculated All three indicators are well-established metrics of glycemic variability
Enhancing Treatment Fidelity Per the NIH Behavior Change Consortium27 a randomized controlled design is the most effective mechanism for finding treatment effects Further it is vital to insure all interventions are delivered as proposed and participants receive the same treatment dose within and across the intervention conditions To achieve this Investigators will make uniform reminder calls use treatment manuals and interventionists will meet every other week with the study PIs for group supervision to discuss relevant topics problem areas and plans for future sessions Sessions will be audio taped so relevant points can be discussed in supervision Ratings of audiotapes will be conducted by the PIs for 25 of the sessions based on a list of key components
Frequent staff trainings is the key to delivering interventions as intended and to prevent drift Therefore staff training will occur twice annually in years 1-3 and once annually in years 4-5 Study PIs will coordinate the trainings which will be delivered collectively by the PIs and co-investigators Training will cover delivery of the prevention program coordinator activities eg processing of blood samples for A1c and treatment fidelity
3 Risks The risks in this study should be minor as many of the intervention components have been employed previously in research and clinical settings with minimal adverse events The risks that come along with any study in which emotional and behavioral factors are discussed include the possibility of discomfort when completing questionnaires and during discussions in the intervention sessions Further given the nature of diabetes management stress or patient-parent conflict may occur when uncontrolled blood sugars are documented The research staff is trained to identify such distress or discomfort early and provide support in the intervention Patients agreeing to participate in the studies will experience the usual risks associated with the treatment of type 1 diabetes the most significant risk is hypoglycemia which is present for all patients undergoing treatment for diabetes with insulin
Another risk associated with this study is the threat to privacy and confidentiality if the secured website is somehow breached However the SNAP software system and the secured web-site has been reviewed and approved by CMHs IT officers Ron Isbell and Jason Ruprecht and CMHs PHI officer Valerie Witmer and the PI has been using this secured website in another study without difficulties Participants will access the questionnaires through the secured web-site and each participant will be assigned a unique study ID code number Names initials or other identifying information will not be used on any of the measures
There may be other unknown risks for which investigators will monitor An additional risk is the potential threat to privacy and confidentiality Investigators believe that these represent minimal risks as defined by the DHHS office of Human Research Protection
A handful of psychological interventions targeting adolescents poor behavioral and emotional functioning demonstrate beneficial effects on disease management and outcomes However no prevention programs exist that equip adolescents with behavioral skills and cognitive strategies shown to reduce both the risk of poor psychological functioning and the risk of negative health outcomes over time Although none of the effective prevention programs developed for healthy youth have been adapted for adolescents with T1D the Penn Resilience Program PRP is a viable candidate because it is a well-established prevention program shown to promote resilience and prevent depression The current study will test a diabetes-specific adaptation of PRP for adolescents with T1D and fill a significant gap in the scientific literature
This studys significance lies not only in its focus on preventing depression a prevalent critical factor influencing diabetes-specific health outcomes but also in its emphasis on ultimately preventing suboptimal glycemic control a common expensive and dangerous problem in pediatric diabetes Individuals with both depression and diabetes incur 45 times the health care costs as those with diabetes alone The focus of the intervention on resilience promotion is innovative because of its potential to fundamentally change risk for depression and set adolescents on a trajectory toward improved adherence and health outcomes Moreover documenting the mechanisms of change that impact critical psychosocial and health outcomes in youth with T1D via a longitudinal randomized controlled design facilitates generalizability to other chronically ill populations given similar management demands on the individual and family and associations with depression
2 Summary of Procedures Investigators will employ a randomized controlled design and compare PRP T1D to a diabetes education intervention EI developed by two CDEs specifically focused on adolescent learning and adolescent needs on resilience characteristics depressive symptoms adherence behaviors and glycemic outcomes Investigators will recruit 280 adolescents with T1D across two cities Chicago and Cincinnati measuring outcomes at baseline post-intervention and at five surveillance visits spanning an additional 24 months All adolescents will participate in 9 sessions lasting approximately 90 minutes each session Assessments occur at baseline 0 months post-intervention 45 months and during the surveillance period 8 12 16 and 28 months
PRP T1D will be led by masters level graduate students enrolled in clinical psychology PhD programs EI will be led by CDE nurses This EI group is preferable to either untreated control or wait-list control groups as it allows for the experimental control of attention peer group sessions and dose on treatment outcomes Both program leaders will receive over 20 hours of training in the program they are leading
Data Collection and Measures Measures assess two primary outcomes depressive symptoms and glycemic control and two mechanisms of change resilience and adherence Assessments occur at baseline post-intervention 45 months and 4 surveillance visits 8 12 16 and 28 months To keep participant burden at a manageable level and to increase retention rate all eligible families will be invited to complete the questionnaires on a secured web-site that they can access while with the research study staff or while at home work in a public library or while in clinic Investigators will use the SNAP Survey Software system which allows for electronic completion of surveys with data directly transferred to data management software in a HIPAA-protected framework The SNAP software eliminates the need for manual data entry reducing the risk of missing data as well as reducing the risk of violating the confidentiality of the data
Hemoglobin A1c will be collected via a small sample of blood and sent to a central laboratory The Diabetes Diagnostic Laboratory at the University of Missouri httpwwwdiabetesmissourieduwill be used This laboratory served as the reference laboratory for the DCCT and NHANES III and IV studies They have extensive experience serving as a central laboratory for A1c values
Continuous glucose monitoring CGM iPro sensor and transmitter by Medtronic will assess glycemic variability The certified diabetes educator CDE or study physician will assist each participant with the insertion and calibration of the device For this study adolescents will be blinded to the CGM values for safety reasons we do not want participants adjusting insulin levels or dietary intake based on sensor readings Adolescents will wear the sensor and transmitter for 3 days After use the sensortransmitter will be collected by the research team via a pre-paid mailing container Once the transmitter is returned the data are downloaded to study computers typically with 290 values per day Investigators then calculate three indicators of glycemic variability SD of the mean of the sensor values mean amplitude of glycemic excursions MAGE and percentage of time spent within glucose ranges The amount of time spent within target values between 70 and 180 below target values below 70 and above target values above 180 will be calculated All three indicators are well-established metrics of glycemic variability
Enhancing Treatment Fidelity Per the NIH Behavior Change Consortium27 a randomized controlled design is the most effective mechanism for finding treatment effects Further it is vital to insure all interventions are delivered as proposed and participants receive the same treatment dose within and across the intervention conditions To achieve this Investigators will make uniform reminder calls use treatment manuals and interventionists will meet every other week with the study PIs for group supervision to discuss relevant topics problem areas and plans for future sessions Sessions will be audio taped so relevant points can be discussed in supervision Ratings of audiotapes will be conducted by the PIs for 25 of the sessions based on a list of key components
Frequent staff trainings is the key to delivering interventions as intended and to prevent drift Therefore staff training will occur twice annually in years 1-3 and once annually in years 4-5 Study PIs will coordinate the trainings which will be delivered collectively by the PIs and co-investigators Training will cover delivery of the prevention program coordinator activities eg processing of blood samples for A1c and treatment fidelity
3 Risks The risks in this study should be minor as many of the intervention components have been employed previously in research and clinical settings with minimal adverse events The risks that come along with any study in which emotional and behavioral factors are discussed include the possibility of discomfort when completing questionnaires and during discussions in the intervention sessions Further given the nature of diabetes management stress or patient-parent conflict may occur when uncontrolled blood sugars are documented The research staff is trained to identify such distress or discomfort early and provide support in the intervention Patients agreeing to participate in the studies will experience the usual risks associated with the treatment of type 1 diabetes the most significant risk is hypoglycemia which is present for all patients undergoing treatment for diabetes with insulin
Another risk associated with this study is the threat to privacy and confidentiality if the secured website is somehow breached However the SNAP software system and the secured web-site has been reviewed and approved by CMHs IT officers Ron Isbell and Jason Ruprecht and CMHs PHI officer Valerie Witmer and the PI has been using this secured website in another study without difficulties Participants will access the questionnaires through the secured web-site and each participant will be assigned a unique study ID code number Names initials or other identifying information will not be used on any of the measures
There may be other unknown risks for which investigators will monitor An additional risk is the potential threat to privacy and confidentiality Investigators believe that these represent minimal risks as defined by the DHHS office of Human Research Protection
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