AnxietyNCT00804180
Group Therapy Intervention for Children and Adolescents With Injection-Related Anxiety and Their Caregivers
A study testing Self-Injection Anxiety Counseling in people with Anxiety, run by Medical College of Wisconsin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Self-Injection Anxiety Counseling
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Aug 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53201-1997
About this study
Official title: Evaluation of a Group Therapy Intervention for Children and Adolescents With Injection-Related Anxiety and Their Caregivers
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.
Read the 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.
- Conditions
- Anxiety
- Being tested
- Self-Injection Anxiety Counseling
- Keywords
- anxiety, injection, needle, pediatric, youth, children, adolescents, cognitive behavioral, behavioral, exposure, group, treatment, chronic illness, adherence
- Medical subject headings
- Anxiety Disorders, Behavior, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Injection Anxiety CounselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Self-Injection Anxiety Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
State Trait Anxiety Inventory: (Spielberger, 1983)
Measured: 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)
Measured: intake, post-treatment, follow-up (2-4wks)
Subjective Units of Distress Scale
Measured: 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)
Measured: intake, post-treatment, follow-up (2-4wks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2008 (estimated)
- Study startOct 2008
- Primary completionAug 2009
- Study completionAug 2009
Why it stopped: Lack of recruitment/participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital and Health System Foundation, Wisconsin
- Responsible party
- Principal investigator, Matt Jandrisevits, Medical College of Wisconsin
- Investigators
- Matthew D Jandrisevits, PhD, Principal investigator, Children's Hospital and Health System Foundation, Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00804180
- Sponsor's protocol ID
- CHW 08/137, GC 742
- Status last verified
- Jun 2015
- First submitted
- 5 Dec 2008
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Group Therapy Intervention for Children and Adolescents With Injection-Related Anxiety and Their Caregivers
- ClinicalTrials.gov ID
- NCT00804180
- Acronym / sponsor ID
- CHW 08/137, GC 742
- Conditions
- Anxiety
- Keywords
- anxiety, injection, needle, pediatric, youth, children, adolescents, cognitive behavioral
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of recruitment/participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Children's Hospital and Health System Foundation, Wisconsin
- Study start
- Oct 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 8 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coping skills intervention | Other | Behavioral: Self-Injection Anxiety CounselingSelf-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. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Injection Anxiety CounselingThis 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. | Behavioural | Coping skills intervention |
Primary outcome
State Trait Anxiety Inventory: (Spielberger, 1983)
Time frame: intake, post-treatment, follow-up (2-4wks)
3 secondary outcomes
Pediatric Quality of Life Inventory - Generic Core Scales (PedsQL) - Short Form: (Varni, Seid, & Kurtin, 2001)
Time frame: intake, post-treatment, follow-up (2-4wks)
Subjective Units of Distress Scale
Time frame: 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)
Time frame: intake, post-treatment, follow-up (2-4wks)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2015.
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew D Jandrisevits, PhD principal investigator
Children's Hospital and Health System Foundation, Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Injection Anxiety Counseling in people with Anxiety, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State Trait Anxiety Inventory: (Spielberger, 1983) (time frame: intake, post-treatment, follow-up (2-4wks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2015.