EpilepsyPhase 1NCT00767026
COPE Intervention for Parents of Children With Epilepsy
A Phase 1 study testing COPE (Creating Opportunities for Parent Empowerment) and Standard education in people with Epilepsy, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The purpose of this study is to determine if the program Creating Opportunities for Parent Empowerment (COPE) is feasible to administer to parents of children with neurological conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- COPE (Creating Opportunities for Parent Empowerment) and Standard education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Dec 2010
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parents of children ages 2-6 with epilepsy
- Children must have been diagnosed with epilepsy for a minimum period of six months
- Parents of children currently admitted to the Children's Hospital Boston inpatient neuroscience unit (CHB-INU) for long term EEG
- High school graduate literate in English
- Access to cellular or home telephone
Who cannot join
- Parents of children who have been diagnosed with co-morbid conditions including, but not limited to: cancer, mitochondrial or metabolic disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
The purpose of this study is to determine if the program Creating Opportunities for Parent Empowerment (COPE) is feasible to administer to parents of children with neurological conditions. The goal of the study is to empower parents by providing them with educational materials designed to teach them how to foster healthy coping skills in their child.
Read the detailed description
Chronic neurological conditions have a significant impact on the child and family system. Parents of children with neurological conditions want to foster the healthy development of their child, however, they struggle with constant feelings of uncertainty, which results in an increased level of stress that can interfere with this goal. Stress in parents also results in anxiety, depression, decreased confidence in care giving skills, ultimately leading to an increase in behavior problems in the child with epilepsy. Pediatric nurses are in a position to intervene with parents of children with epilepsy to facilitate coping with and adjustment to these issues.
Although many researchers have identified the relationship between effective parental coping and the improved psychosocial outcomes of children with epilepsy, little has been done to test interventions that may be effective in improving the coping strategies of parents of children with epilepsy. COPE (Creating Opportunities for Parent Empowerment) is a nurse coached educational intervention, which shows promise for improving coping in parents of hospitalized children. This is particularly significant for parents of children with neurological conditions, as these conditions are associated with repeated hospitalizations, stigma, and numerous comorbidities. Collectively, these factors make epilepsy one of the most stress producing pediatric conditions for parents to manage.
This study will help to advance Nursing science in several ways. First, this study will develop an intervention that can be used to teach parents how to help their children cope with living with a chronic condition. This intervention could further advance Nursing science because it could be adapted and trials performed with children who have a wide variety of medical conditions. This study has the potential to improve the way we prepare parents and children for hospitalization. This study will guide nursing in how to best help families cope with caring for a child with a chronic condition.
The research consent form has been reviewed and approved by the IRB at both Children's Hospital Boston and Boston College. The consent form addresses the following topics:
- Why the research is being conducted and what is its purpose B. Who is conducting the study and where it is being conducted C. How individuals are selected to be in the study and how many will participate D. What the participant needs to do in the research study E. What are the risks of the study and what could go wrong F. What are the benefits of the study G. Costs and payments associated with the study H. What happens to the information obtained from the study and what about confidentiality I. What are the choices if the participant does not want to be involved with the study J. What are the rights of a research participant K. HIPAA
- Conditions
- Epilepsy
- Being tested
- COPE (Creating Opportunities for Parent Empowerment), Standard education
- Keywords
- Epilepsy, Caregiver Burden, Parenting a Child with a Chronic Illness
- Medical subject headings
- Epilepsy, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COPE (Creating Opportunities for Parent Empowerment)Behavioural
Twenty-four hours after admission to the hospital, this group will receive Phase I of the study which includes information focusing on what parents can expect during their child's hospital stay, and how they can help their child cope with the experience. Prior to discharge parents will receive additional information pertaining to Phase II of the study. At 3 days post discharge, the participants will receive a follow up phone call to reiterate the information provided in Phase II and ask parents about questions or problems since discharge. One week following, participants will be asked to complete assessments. At 6 weeks after the hospitalization they will receive Phase III, which includes, additional information on behaviors parents can expect to see in their children following a hospitalization. Parents will be given a workbook that will teach them techniques to help their child cope. Then at 6 weeks after the last intervention phase, participants will again complete assessments.
Standard educationBehavioural
This group will receive standard education regarding medication management and seizure first aid. This group will also receive information, oral and written, that will discuss tests to be administered during the hospitalization. The usual care group also receives a call at home within one week after discharge from a nurse to ask if they had any problems with their stay, and if they have any further needs or questions.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Behavioral: COPE (Creating Opportunities for Parent Empowerment) |
| 2 | Active comparator | Not described Receives: Behavioral: Standard education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental depression
Measured: 24 hours, 1-, 8 -, and 12- weeks after discharge
Parental Anxiety
Measured: 24 hours, 1-, 8 -, and 12- weeks after discharge
Confidence in Parenting Skills
Measured: 24 hours, 1-, 8 -, and 12- weeks after discharge
Secondary outcomes (1)
Behavior problems in the child
Measured: 24 hours, 1-, 8 -, and 12- weeks after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Investigators
- Lisa V Duffy, PhD(c), CPNP-PC, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00767026
- Sponsor's protocol ID
- 1F31NR010645-01
- Other IDs
- F31NR010645
- Status last verified
- Jun 2011
- First submitted
- 3 Oct 2008
- Last updated
- 22 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Amdam, A., Langslet, B., & Holmseth, T. (2001). The penguin: A teaching Ppan for children with epilepsy. In: Pfafflin, M., Fraser, Thorbecke et al. (Eds). Comprehensive care for people with epilepsy. London: John Libbey.
Austin JK, Dunn DW. Children with epilepsy: quality of life and psychosocial needs. Annu Rev Nurs Res. 2000;18:26-47.
PubMed 10918931Austin JK, Harezlak J, Dunn DW, Huster GA, Rose DF, Ambrosius WT. Behavior problems in children before first recognized seizures. Pediatrics. 2001 Jan;107(1):115-22. doi: 10.1542/peds.107.1.115.
PubMed 11134444Austin, J.K., McNelis, A.M., Shore, C.P., Dunn, D.W., & Musick, B. (2002). A feasibility study of a family seizure management program: "Be Seizure Smart." Journal of Neuroscience Nursing, 34(1), 30-37.
Austin JK, Dunn DW, Johnson CS, Perkins SM. Behavioral issues involving children and adolescents with epilepsy and the impact of their families: recent research data. Epilepsy Behav. 2004 Oct;5 Suppl 3:S33-41. doi: 10.1016/j.yebeh.2004.06.014.
PubMed 15351344Aytch LS, Hammond R, White C. Seizures in infants and young children: an exploratory study of family experiences and needs for information and support. J Neurosci Nurs. 2001 Oct;33(5):278-85. doi: 10.1097/01376517-200110000-00008.
PubMed 11668886Bazil CW. Comprehensive care of the epilepsy patient--control, comorbidity, and cost. Epilepsia. 2004;45 Suppl 6:3-12. doi: 10.1111/j.0013-9580.2004.455002.x.
PubMed 15315510Berg AT, Smith SN, Frobish D, Levy SR, Testa FM, Beckerman B, Shinnar S. Special education needs of children with newly diagnosed epilepsy. Dev Med Child Neurol. 2005 Nov;47(11):749-53. doi: 10.1017/S001216220500157X.
PubMed 16225738Buelow JM, McNelis A, Shore CP, Austin JK. Stressors of parents of children with epilepsy and intellectual disability. J Neurosci Nurs. 2006 Jun;38(3):147-54, 176. doi: 10.1097/01376517-200606000-00003.
PubMed 16817666Carlton-Ford S, Miller R, Nealeigh N, Sanchez N. The effects of perceived stigma and psychological over-control on the behavioural problems of children with epilepsy. Seizure. 1997 Oct;6(5):383-91. doi: 10.1016/s1059-1311(97)80038-6.
PubMed 9663802Chapieski L, Brewer V, Evankovich K, Culhane-Shelburne K, Zelman K, Alexander A. Adaptive functioning in children with seizures: impact of maternal anxiety about epilepsy. Epilepsy Behav. 2005 Sep;7(2):246-52. doi: 10.1016/j.yebeh.2005.05.002.
PubMed 15996525Hufford, B.S., Glueckauf, R.L., & Webb, P.M. (1999). Home-based, interactive videoconferencing for adolescents with epilepsy and their families. Rehabilitation Psychology, 44(2), 176-193.
Jacoby A, Snape D, Baker GA. Epilepsy and social identity: the stigma of a chronic neurological disorder. Lancet Neurol. 2005 Mar;4(3):171-8. doi: 10.1016/S1474-4422(05)01014-8.
PubMed 15721827Keller D, Honig AS. Maternal and paternal stress in families with school-aged children with disabilities. Am J Orthopsychiatry. 2004 Jul;74(3):337-48. doi: 10.1037/0002-9432.74.3.337.
PubMed 15291710Low SM, Stocker C. Family functioning and children's adjustment: associations among parents' depressed mood, marital hostility, parent-child hostility, and children's adjustment. J Fam Psychol. 2005 Sep;19(3):394-403. doi: 10.1037/0893-3200.19.3.394.
PubMed 16221020
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COPE Intervention for Parents of Children With Epilepsy
- ClinicalTrials.gov ID
- NCT00767026
- Acronym / sponsor ID
- 1F31NR010645-01
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Caregiver Burden, Parenting a Child with a Chronic Illness
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Jan 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 6 Oct 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 purpose of this study is to determine if the program Creating Opportunities for Parent Empowerment (COPE) is feasible to administer to parents of children with neurological conditions. The goal of the study is to empower parents by providing them with educational materials designed to teach them how to foster healthy coping skills in their child.
Detailed description
Chronic neurological conditions have a significant impact on the child and family system. Parents of children with neurological conditions want to foster the healthy development of their child, however, they struggle with constant feelings of uncertainty, which results in an increased level of stress that can interfere with this goal. Stress in parents also results in anxiety, depression, decreased confidence in care giving skills, ultimately leading to an increase in behavior problems in the child with epilepsy. Pediatric nurses are in a position to intervene with parents of children with epilepsy to facilitate coping with and adjustment to these issues.
Although many researchers have identified the relationship between effective parental coping and the improved psychosocial outcomes of children with epilepsy, little has been done to test interventions that may be effective in improving the coping strategies of parents of children with epilepsy. COPE (Creating Opportunities for Parent Empowerment) is a nurse coached educational intervention, which shows promise for improving coping in parents of hospitalized children. This is particularly significant for parents of children with neurological conditions, as these conditions are associated with repeated hospitalizations, stigma, and numerous comorbidities. Collectively, these factors make epilepsy one of the most stress producing pediatric conditions for parents to manage.
This study will help to advance Nursing science in several ways. First, this study will develop an intervention that can be used to teach parents how to help their children cope with living with a chronic condition. This intervention could further advance Nursing science because it could be adapted and trials performed with children who have a wide variety of medical conditions. This study has the potential to improve the way we prepare parents and children for hospitalization. This study will guide nursing in how to best help families cope with caring for a child with a chronic condition.
The research consent form has been reviewed and approved by the IRB at both Children's Hospital Boston and Boston College. The consent form addresses the following topics:
- Why the research is being conducted and what is its purpose B. Who is conducting the study and where it is being conducted C. How individuals are selected to be in the study and how many will participate D. What the participant needs to do in the research study E. What are the risks of the study and what could go wrong F. What are the benefits of the study G. Costs and payments associated with the study H. What happens to the information obtained from the study and what about confidentiality I. What are the choices if the participant does not want to be involved with the study J. What are the rights of a research participant K. HIPAA
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: COPE (Creating Opportunities for Parent Empowerment) |
| 2 | Active comparator | Behavioral: Standard education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Parents of children ages 2-6 with epilepsy
- Children must have been diagnosed with epilepsy for a minimum period of six months
- Parents of children currently admitted to the Children's Hospital Boston inpatient neuroscience unit (CHB-INU) for long term EEG
- High school graduate literate in English
- Access to cellular or home telephone
Key exclusion criteria (1 listed)
- Parents of children who have been diagnosed with co-morbid conditions including, but not limited to: cancer, mitochondrial or metabolic 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 |
|---|---|---|
| COPE (Creating Opportunities for Parent Empowerment)Twenty-four hours after admission to the hospital, this group will receive Phase I of the study which includes information focusing on what parents can expect during their child's hospital stay, and how they can help their child cope with the experience. Prior to discharge parents will receive additional information pertaining to Phase II of the study. At 3 days post discharge, the participants will receive a follow up phone call to reiterate the information provided in Phase II and ask parents about questions or problems since discharge. One week following, participants will be asked to complete assessments. At 6 weeks after the hospitalization they will receive Phase III, which includes, additional information on behaviors parents can expect to see in their children following a hospitalization. Parents will be given a workbook that will teach them techniques to help their child cope. Then at 6 weeks after the last intervention phase, participants will again complete assessments. | Behavioural | 1 |
| Standard educationThis group will receive standard education regarding medication management and seizure first aid. This group will also receive information, oral and written, that will discuss tests to be administered during the hospitalization. The usual care group also receives a call at home within one week after discharge from a nurse to ask if they had any problems with their stay, and if they have any further needs or questions. | Behavioural | 2 |
Primary outcome
Parental depression
Time frame: 24 hours, 1-, 8 -, and 12- weeks after discharge
Parental Anxiety
Time frame: 24 hours, 1-, 8 -, and 12- weeks after discharge
Confidence in Parenting Skills
Time frame: 24 hours, 1-, 8 -, and 12- weeks after discharge
1 secondary outcome
Behavior problems in the child
Time frame: 24 hours, 1-, 8 -, and 12- weeks after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2011.
- BackgroundAmdam, A., Langslet, B., & Holmseth, T. (2001). The penguin: A teaching Ppan for children with epilepsy. In: Pfafflin, M., Fraser, Thorbecke et al. (Eds). Comprehensive care for people with epilepsy. London: John Libbey.
- Background: PubMed 10918931Austin JK, Dunn DW. Children with epilepsy: quality of life and psychosocial needs. Annu Rev Nurs Res. 2000;18:26-47.
- Background: PubMed 11134444Austin JK, Harezlak J, Dunn DW, Huster GA, Rose DF, Ambrosius WT. Behavior problems in children before first recognized seizures. Pediatrics. 2001 Jan;107(1):115-22. doi: 10.1542/peds.107.1.115.
- BackgroundAustin, J.K., McNelis, A.M., Shore, C.P., Dunn, D.W., & Musick, B. (2002). A feasibility study of a family seizure management program: "Be Seizure Smart." Journal of Neuroscience Nursing, 34(1), 30-37.
- Background: PubMed 15351344Austin JK, Dunn DW, Johnson CS, Perkins SM. Behavioral issues involving children and adolescents with epilepsy and the impact of their families: recent research data. Epilepsy Behav. 2004 Oct;5 Suppl 3:S33-41. doi: 10.1016/j.yebeh.2004.06.014.
- Background: PubMed 11668886Aytch LS, Hammond R, White C. Seizures in infants and young children: an exploratory study of family experiences and needs for information and support. J Neurosci Nurs. 2001 Oct;33(5):278-85. doi: 10.1097/01376517-200110000-00008.
- Background: PubMed 15315510Bazil CW. Comprehensive care of the epilepsy patient--control, comorbidity, and cost. Epilepsia. 2004;45 Suppl 6:3-12. doi: 10.1111/j.0013-9580.2004.455002.x.
- Background: PubMed 16225738Berg AT, Smith SN, Frobish D, Levy SR, Testa FM, Beckerman B, Shinnar S. Special education needs of children with newly diagnosed epilepsy. Dev Med Child Neurol. 2005 Nov;47(11):749-53. doi: 10.1017/S001216220500157X.
- Background: PubMed 16817666Buelow JM, McNelis A, Shore CP, Austin JK. Stressors of parents of children with epilepsy and intellectual disability. J Neurosci Nurs. 2006 Jun;38(3):147-54, 176. doi: 10.1097/01376517-200606000-00003.
- Background: PubMed 9663802Carlton-Ford S, Miller R, Nealeigh N, Sanchez N. The effects of perceived stigma and psychological over-control on the behavioural problems of children with epilepsy. Seizure. 1997 Oct;6(5):383-91. doi: 10.1016/s1059-1311(97)80038-6.
- Background: PubMed 15996525Chapieski L, Brewer V, Evankovich K, Culhane-Shelburne K, Zelman K, Alexander A. Adaptive functioning in children with seizures: impact of maternal anxiety about epilepsy. Epilepsy Behav. 2005 Sep;7(2):246-52. doi: 10.1016/j.yebeh.2005.05.002.
- BackgroundHufford, B.S., Glueckauf, R.L., & Webb, P.M. (1999). Home-based, interactive videoconferencing for adolescents with epilepsy and their families. Rehabilitation Psychology, 44(2), 176-193.
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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.
Lisa V Duffy, PhD(c), CPNP-PC principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing COPE (Creating Opportunities for Parent Empowerment) and Standard education in people with Epilepsy, run by Boston Children's Hospital 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 5 inclusion and 1 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: finished, as of the sponsor's last update on 22 Jun 2011. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Parental depression (time frame: 24 hours, 1-, 8 -, and 12- weeks after discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00767026, which also lists 31 linked publications.
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 22 Jun 2011.