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

NCT00804180 | Withdrawn

• 1 other identifier: CHW 08/137, GC 742
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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:

1. 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. 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. 3.Reduced anxiety immediately following exposure to feared injection- related stimuli.
4. 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.

Conditions

Anxiety

Keywords

anxiety; injection; needle; pediatric; youth; children; adolescents; cognitive behavioral; behavioral; exposure; group; treatment; chronic illness; adherence

Outcome Measures

Primary Outcomes (1)

• State Trait Anxiety Inventory: (Spielberger, 1983)

  intake, post-treatment, follow-up (2-4wks)

Secondary Outcomes (3)

• Pediatric Quality of Life Inventory - Generic Core Scales (PedsQL) - Short Form: (Varni, Seid, & Kurtin, 2001)

  intake, post-treatment, follow-up (2-4wks)

• Subjective Units of Distress Scale

  intake, before/after exposures during group sessions, post-treatment, follow-up (2-4wks)

• Parental Report of Child's Injection Adherence Percentage (over period of 10 physician-prescribed injection time points)

  intake, post-treatment, follow-up (2-4wks)

Study Arms (1)

Coping skills intervention

OTHER

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.

Behavioral: Self-Injection Anxiety Counseling

Interventions

Self-Injection Anxiety Counseling BEHAVIORAL

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.

Coping skills intervention

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Children's Hospital and Health System Foundation, Wisconsin: collaborator

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53201-1997, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Behavior; Chronic Disease

Condition Hierarchy (Ancestors)

Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthew D Jandrisevits, PhD

  Children's Hospital and Health System Foundation, Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychologist

Study Record Dates

• First Submitted: December 5, 2008
• First Posted: December 8, 2008
• Study Start: October 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: June 23, 2015

Record last verified: 2015-06

Locations

US (1)