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Group Therapy Intervention for Children and Adolescents With Injection-Related Anxiety and Their Caregivers

Primary Purpose

Anxiety

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-Injection Anxiety Counseling
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring anxiety, injection, needle, pediatric, youth, children, adolescents, cognitive behavioral, behavioral, exposure, group, treatment, chronic illness, adherence

Eligibility Criteria

8 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • children/adolescents aged 8-17 years.
  • presence of a regular caregiver who can participate in weekly group sessions
  • injection-related anxiety resulting in either inadequate compliance with injections or significant distress during injections

Exclusion Criteria:

  • severe cognitive impairment
  • aggression and/or dangerous behavior in the last six months
  • currently at risk of harm to themselves or others
  • extreme mood lability
  • poorly controlled comorbid psychiatric disorders
  • active substance use
  • current significant legal involvement
  • anxiety that impairs daily functioning beyond injections

Sites / Locations

  • Children's Hospital of Wisconsin

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Coping skills intervention

Arm Description

Self-Injection Anxiety Counseling: Evaluation of a group treatment for injection-related anxiety. The intention of the study is to obtain basic evaluation of a clinical treatment offered in a natural clinic setting, and does not include a control group, or procedure for random assignment of participants.

Outcomes

Primary Outcome Measures

State Trait Anxiety Inventory: (Spielberger, 1983)

Secondary Outcome Measures

Pediatric Quality of Life Inventory - Generic Core Scales (PedsQL) - Short Form: (Varni, Seid, & Kurtin, 2001)
Subjective Units of Distress Scale
Parental Report of Child's Injection Adherence Percentage (over period of 10 physician-prescribed injection time points)

Full Information

First Posted
December 5, 2008
Last Updated
June 19, 2015
Sponsor
Medical College of Wisconsin
Collaborators
Children's Hospital and Health System Foundation, Wisconsin
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1. Study Identification

Unique Protocol Identification Number
NCT00804180
Brief Title
Group Therapy Intervention for Children and Adolescents With Injection-Related Anxiety and Their Caregivers
Official Title
Evaluation of a Group Therapy Intervention for Children and Adolescents With Injection-Related Anxiety and Their Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of recruitment/participants
Study Start Date
October 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
Collaborators
Children's Hospital and Health System Foundation, Wisconsin

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 anxiety.Hypotheses include: 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. 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. Reduced anxiety immediately following exposure to feared injection- related stimuli. 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 individual's 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
anxiety, injection, needle, pediatric, youth, children, adolescents, cognitive behavioral, behavioral, exposure, group, treatment, chronic illness, adherence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Coping skills intervention
Arm Type
Other
Arm Description
Self-Injection Anxiety Counseling: Evaluation of a group treatment for injection-related anxiety. The intention of the study is to obtain basic evaluation of a clinical treatment offered in a natural clinic setting, and does not include a control group, or procedure for random assignment of participants.
Intervention Type
Behavioral
Intervention Name(s)
Self-Injection Anxiety Counseling
Intervention Description
This 5-session group intervention involves: psychoeducation; physiological treatment of anxiety though the instruction and practice of relaxation techniques; cognitive restructuring for anxiety-reduction; practice physiological and cognitive treatments through in vivo injection procedures; and problem solving strategies to generalize treatment gains.
Primary Outcome Measure Information:
Title
State Trait Anxiety Inventory: (Spielberger, 1983)
Time Frame
intake, post-treatment, follow-up (2-4wks)
Secondary Outcome Measure Information:
Title
Pediatric Quality of Life Inventory - Generic Core Scales (PedsQL) - Short Form: (Varni, Seid, & Kurtin, 2001)
Time Frame
intake, post-treatment, follow-up (2-4wks)
Title
Subjective Units of Distress Scale
Time Frame
intake, before/after exposures during group sessions, post-treatment, follow-up (2-4wks)
Title
Parental Report of Child's Injection Adherence Percentage (over period of 10 physician-prescribed injection time points)
Time Frame
intake, post-treatment, follow-up (2-4wks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: children/adolescents aged 8-17 years. presence of a regular caregiver who can participate in weekly group sessions injection-related anxiety resulting in either inadequate compliance with injections or significant distress during injections Exclusion Criteria: severe cognitive impairment aggression and/or dangerous behavior in the last six months currently at risk of harm to themselves or others extreme mood lability poorly controlled comorbid psychiatric disorders active substance use current significant legal involvement anxiety that impairs daily functioning beyond injections
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew D Jandrisevits, PhD
Organizational Affiliation
Children's Hospital and Health System Foundation, Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53201-1997
Country
United States

12. IPD Sharing Statement

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Group Therapy Intervention for Children and Adolescents With Injection-Related Anxiety and Their Caregivers

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