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

This study has been terminated.
(Lack of recruitment/participants)
Sponsor:
Collaborator:
Children's Hospital and Health System Foundation, Wisconsin
Information provided by:
Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00804180
First received: December 5, 2008
Last updated: September 24, 2009
Last verified: September 2009
  Purpose

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:

  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.

Condition Intervention
Anxiety
Behavioral: Self-Injection Anxiety Counseling

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of a Group Therapy Intervention for Children and Adolescents With Injection-Related Anxiety and Their Caregivers

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • State Trait Anxiety Inventory: (Spielberger, 1983) [ Time Frame: intake, post-treatment, follow-up (2-4wks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pediatric Quality of Life Inventory - Generic Core Scales (PedsQL) - Short Form: (Varni, Seid, & Kurtin, 2001) [ Time Frame: intake, post-treatment, follow-up (2-4wks) ] [ Designated as safety issue: No ]
  • Subjective Units of Distress Scale [ Time Frame: intake, before/after exposures during group sessions, post-treatment, follow-up (2-4wks) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: October 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Coping skills intervention
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.
Behavioral: Self-Injection Anxiety Counseling
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.

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.

  Eligibility

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00804180

Locations
United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53201-1997
Sponsors and Collaborators
Medical College of Wisconsin
Children's Hospital and Health System Foundation, Wisconsin
Investigators
Principal Investigator: Matthew D Jandrisevits, PhD Children's Hospital and Health System Foundation, Wisconsin
  More Information

No publications provided

Responsible Party: Matthew D. Jandrisevits, Ph.D., Children's Hospital of Wisconsin
ClinicalTrials.gov Identifier: NCT00804180     History of Changes
Other Study ID Numbers: CHW 08/137, GC 742
Study First Received: December 5, 2008
Last Updated: September 24, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:
anxiety
injection
needle
pediatric
youth
children
adolescents
cognitive behavioral
behavioral
exposure
group
treatment
chronic illness
adherence

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on November 24, 2014