Ignite Creation Date:
2024-05-05 @ 9:03 PM
Last Modification Date:
2024-10-26 @ 9:58 AM
Study NCT ID:
NCT00804180
Status:
WITHDRAWN
Last Update Posted:
2015-06-23
First Post:
2008-12-05
Brief Title:
Group Therapy Intervention for Children and Adolescents With Injection-Related Anxiety and Their Caregivers
Sponsor:
Medical College of Wisconsin
Organization:
Medical College of Wisconsin
Study Overview
Official Title:
Evaluation of a Group Therapy Intervention for Children and Adolescents With Injection-Related Anxiety and Their Caregivers
Status:
WITHDRAWN
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of recruitmentparticipants
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The specific aim of this project is to determine the impact of this group therapy intervention on improving adherence coping and functioning among children and adolescents with disease processes requiring injections who experience injection-related anxietyHypotheses include
1 General psychosocial quality of life improvements from beginning to post-treatment as well as maintenance of these improvements 2-4 weeks following the termination of treatment for both youth and parents
2 Reduced injection-related anxiety from baseline to post-treatment as well as maintenance of this improvement 2-4 weeks following the end of treatment for both youth and parents
3 Reduced anxiety immediately following exposure to feared injection- related stimuli
4 For participants experiencing poor adherence to medical treatment improvement in adherence as reported by both parents and youth from baseline to post-treatment as well as maintenance of these improvements 2-4 weeks following the end of treatment
1 General psychosocial quality of life improvements from beginning to post-treatment as well as maintenance of these improvements 2-4 weeks following the termination of treatment for both youth and parents
2 Reduced injection-related anxiety from baseline to post-treatment as well as maintenance of this improvement 2-4 weeks following the end of treatment for both youth and parents
3 Reduced anxiety immediately following exposure to feared injection- related stimuli
4 For participants experiencing poor adherence to medical treatment improvement in adherence as reported by both parents and youth from baseline to post-treatment as well as maintenance of these improvements 2-4 weeks following the end of treatment
Detailed Description:
The proposed intervention protocol is a modification of an existing empirically developed treatment Self-Injection Anxiety Counseling for adults with injection related anxiety who rely on self-injection for illness management Mohr Cox Boudewyn 2003 Self-Injection Anxiety Counseling SIAC was developed to assist psychologists and medical staff in working with patients individually to develop strategies to reduce anxiety and increase an individuals ability to self-inject This treatment protocol has been found to result in increased self injection in patients who experienced injection anxiety prior to undergoing this treatment Mohr Cox Merluzzi 2005 Permission has been obtained from Dr Mohr to modify this treatment manual to be applied to youth in group setting
This modified group protocol consists of five group sessions The goals of the first session include development of a group identity psychoeducation and physiological treatment of anxiety though the instruction and practice of relaxation techniques The second session introduces a cognitive component to anxiety reduction and focuses on unhelpful thoughts and strategies youth and caregivers can use to counteract these thoughts The third session implements the previously learned physiological and cognitive treatments through in vivo injection practice A registered nurse skilled in working with youth and caregivers on self-injection will be present and active throughout this session and all infection control procedures will be followed Problem solving strategies are implemented in the fourth session to reduce any difficulties encountered by participants as they practiced their injection goal throughout the week The fifth session will occur two weeks after the fourth session This extra week between sessions allows for additional practice and problem solving related to injection goals The last session reviews problem solving strategies and celebrates the success of participants
Relevant outcomes for hypotheses testing will be measured before treatment after completion of treatment and at follow-up one measure of injection-related anxiety will be utilized more frequently throughout the treatment
This modified group protocol consists of five group sessions The goals of the first session include development of a group identity psychoeducation and physiological treatment of anxiety though the instruction and practice of relaxation techniques The second session introduces a cognitive component to anxiety reduction and focuses on unhelpful thoughts and strategies youth and caregivers can use to counteract these thoughts The third session implements the previously learned physiological and cognitive treatments through in vivo injection practice A registered nurse skilled in working with youth and caregivers on self-injection will be present and active throughout this session and all infection control procedures will be followed Problem solving strategies are implemented in the fourth session to reduce any difficulties encountered by participants as they practiced their injection goal throughout the week The fifth session will occur two weeks after the fourth session This extra week between sessions allows for additional practice and problem solving related to injection goals The last session reviews problem solving strategies and celebrates the success of participants
Relevant outcomes for hypotheses testing will be measured before treatment after completion of treatment and at follow-up one measure of injection-related anxiety will be utilized more frequently throughout the treatment
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