COPE Intervention for Parents of Children With Epilepsy

NCT00767026 | Completed Phase 1 DMC

• 2 other identifiers: 1F31NR010645-01F31NR010645
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Epilepsy

Keywords

Epilepsy; Caregiver Burden; Parenting a Child with a Chronic Illness

Outcome Measures

Primary Outcomes (3)

• Parental depression

  24 hours, 1-, 8 -, and 12- weeks after discharge

• Parental Anxiety

  24 hours, 1-, 8 -, and 12- weeks after discharge

• Confidence in Parenting Skills

  24 hours, 1-, 8 -, and 12- weeks after discharge

Secondary Outcomes (1)

• Behavior problems in the child

  24 hours, 1-, 8 -, and 12- weeks after discharge

Study Arms (2)

1

EXPERIMENTAL

Behavioral: COPE (Creating Opportunities for Parent Empowerment)

2

ACTIVE COMPARATOR

Behavioral: Standard education

Interventions

COPE (Creating Opportunities for Parent Empowerment) BEHAVIORAL

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.

1

Standard education BEHAVIORAL

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.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Parents of children who have been diagnosed with co-morbid conditions including, but not limited to: cancer, mitochondrial or metabolic disorders

Sponsors & Collaborators

• Boston Children's Hospital: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Related Publications (31)

• 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.

  BACKGROUND

• Austin JK, Dunn DW. Children with epilepsy: quality of life and psychosocial needs. Annu Rev Nurs Res. 2000;18:26-47.

  PMID: 10918931 BACKGROUND

• Austin 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.

  PMID: 11134444 BACKGROUND

• Austin, 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

• 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.

  PMID: 15351344 BACKGROUND

• Aytch 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.

  PMID: 11668886 BACKGROUND

• Bazil 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.

  PMID: 15315510 BACKGROUND

• Berg 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.

  PMID: 16225738 BACKGROUND

• Buelow 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.

  PMID: 16817666 BACKGROUND

• Carlton-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.

  PMID: 9663802 BACKGROUND

• Chapieski 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.

  PMID: 15996525 BACKGROUND

• Hufford, 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.

  BACKGROUND

• 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.

  PMID: 15721827 BACKGROUND

• Keller 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.

  PMID: 15291710 BACKGROUND

• Low 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.

  PMID: 16221020 BACKGROUND

• Melnyk BM. Coping with unplanned childhood hospitalization: effects of informational interventions on mothers and children. Nurs Res. 1994 Jan-Feb;43(1):50-5.

  PMID: 8295841 BACKGROUND

• Melnyk BM. Parental coping with childhood hospitalization: a theoretical framework to guide research and clinical interventions. Matern Child Nurs J. 1995 Oct-Dec;23(4):123-31.

  PMID: 8826078 BACKGROUND

• Melnyk BM, Alpert-Gillis LJ, Hensel PB, Cable-Beiling RC, Rubenstein JS. Helping mothers cope with a critically ill child: a pilot test of the COPE intervention. Res Nurs Health. 1997 Feb;20(1):3-14. doi: 10.1002/(sici)1098-240x(199702)20:13.0.co;2-q.

  PMID: 9024473 BACKGROUND

• Melnyk BM, Alpert-Gillis LJ. The COPE program: a strategy to improve outcomes of critically ill young children and their parents. Pediatr Nurs. 1998 Nov-Dec;24(6):521-7.

  PMID: 10085993 BACKGROUND

• Melnyk BM, Feinstein NF, Moldenhouer Z, Small L. Coping in parents of children who are chronically ill: strategies for assessment and intervention. Pediatr Nurs. 2001 Nov-Dec;27(6):548-58.

  PMID: 12024526 BACKGROUND

• Melnyk BM, Alpert-Gillis L, Feinstein NF, Crean HF, Johnson J, Fairbanks E, Small L, Rubenstein J, Slota M, Corbo-Richert B. Creating opportunities for parent empowerment: program effects on the mental health/coping outcomes of critically ill young children and their mothers. Pediatrics. 2004 Jun;113(6):e597-607. doi: 10.1542/peds.113.6.e597.

  PMID: 15173543 BACKGROUND

• Mu PF, Wong TT, Chang KP, Kwan SY. Predictors of maternal depression for families having a child with epilepsy. J Nurs Res. 2001 Sep;9(4):116-26.

  PMID: 11789131 BACKGROUND

• Mu PF. Paternal reactions to a child with epilepsy: uncertainty, coping strategies, and depression. J Adv Nurs. 2005 Feb;49(4):367-76. doi: 10.1111/j.1365-2648.2004.03300.x.

  PMID: 15701151 BACKGROUND

• Mu PF, Kuo HC, Chang KP. Boundary ambiguity, coping patterns and depression in mothers caring for children with epilepsy in Taiwan. Int J Nurs Stud. 2005 Mar;42(3):273-82. doi: 10.1016/j.ijnurstu.2004.07.002.

  PMID: 15708014 BACKGROUND

• Oostrom KJ, Schouten A, Kruitwagen CL, Peters AC, Jennekens-Schinkel A; Dutch Study Group of Epilepsy in Childhood. Parents' perceptions of adversity introduced by upheaval and uncertainty at the onset of childhood epilepsy. Epilepsia. 2001 Nov;42(11):1452-60. doi: 10.1046/j.1528-1157.2001.14201.x.

  PMID: 11879349 BACKGROUND

• Sawin KJ, Lannon SL, Austin JK. Camp experiences and attitudes toward epilepsy: a pilot study. J Neurosci Nurs. 2001 Feb;33(1):57-64. doi: 10.1097/01376517-200102000-00008.

  PMID: 11233363 BACKGROUND

• Shore CP, Austin JK, Huster GA, Dunn DW. Identifying risk factors for maternal depression in families of adolescents with epilepsy. J Spec Pediatr Nurs. 2002 Apr-Jun;7(2):71-80. doi: 10.1111/j.1744-6155.2002.tb00153.x.

  PMID: 12061495 BACKGROUND

• Snead K, Ackerson J, Bailey K, Schmitt MM, Madan-Swain A, Martin RC. Taking charge of epilepsy: the development of a structured psychoeducational group intervention for adolescents with epilepsy and their parents. Epilepsy Behav. 2004 Aug;5(4):547-56. doi: 10.1016/j.yebeh.2004.04.012.

  PMID: 15256193 BACKGROUND

• Tieffenberg JA, Wood EI, Alonso A, Tossutti MS, Vicente MF. A randomized field trial of ACINDES: a child-centered training model for children with chronic illnesses (asthma and epilepsy). J Urban Health. 2000 Jun;77(2):280-97. doi: 10.1007/BF02390539.

  PMID: 10856009 BACKGROUND

• Thomas SV, Bindu VB. Psychosocial and economic problems of parents of children with epilepsy. Seizure. 1999 Feb;8(1):66-9. doi: 10.1053/seiz.1998.0241.

  PMID: 10091852 BACKGROUND

• Williams J, Steel C, Sharp GB, DelosReyes E, Phillips T, Bates S, Lange B, Griebel ML. Parental anxiety and quality of life in children with epilepsy. Epilepsy Behav. 2003 Oct;4(5):483-6. doi: 10.1016/s1525-5050(03)00159-8.

  PMID: 14527488 BACKGROUND

MeSH Terms

Conditions

Epilepsy; Caregiver Burden

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Lisa V Duffy, PhD(c), CPNP-PC

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 3, 2008
• First Posted: October 6, 2008
• Study Start: January 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: June 22, 2011

Record last verified: 2011-06

Locations

US (1)