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出境医 / 临床实验 / Development of a Self- Management Program for Parents With Spinal Cord Injury and Disease

Development of a Self- Management Program for Parents With Spinal Cord Injury and Disease

Study Description
Brief Summary:
The purpose of this project was to develop and pilot test a self-management program targeted toward individuals with Spinal Cord Injury/Disease (SCI/D) who are current parents or who are considering becoming parents. This Parenting Self-Management Program (PSMP) will allow parents to identify their goals for successful family participation and provide a structure for professionals to use when working with parents with SCI/D to best meet their needs. A draft PSMP was assembled by members of the research team. This draft was reviewed by experienced parents with SCI/D and professionals who work with individuals who have SCI/D through key informant interviews or focus groups. The feedback was used to modify the draft program and the PSMP was pilot tested with a group of 10 individuals with SCI/D who are new parents, newly injured or who want to improve their participation in parenting activities.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Behavioral: Parenting Self-Management Program Not Applicable

Detailed Description:

The project used a self-management approach grounded in self-efficacy theory to increase parenting self-efficacy among persons with spinal cord injury/disease (SCI/D). Program content focused on skill building through opportunities to master techniques and strategies; role modeling, problem solving, decision making, goal setting, and provision of reliable information. The use of a self-management program may also place parents with SCI/D at ease in sharing needs, as it is not an expert model by which a professional is passing judgment on their ability to care for their children. Many parents with disabilities are hesitant to seek professional services for fear of negative consequences such as losing custody of their children. Developing a program that is conducted as a partnership whereby parents direct much of the pace and content may be considered less threatening and more beneficial to those who have experienced distrust of the healthcare system.

There are no other self-management programs that specifically address the needs of parents with SCI/D. The project created a self-management program that was piloted in the St. Louis region and can be replicated across the country among other communities. While the national coordination center for families with disabilities, Through the Looking Glass, provides resource materials to parents across the country, they do not provide a structure for individual problem solving and to meet the needs of parents SCI/D on an individualized level. Providing a format for parents with SCI/D to successfully fulfill their parenting roles has a highly significant social implication; parents will be equipped to meet potential challenges and enjoy participation in their families. Limiting discrimination in the courts, seeking school accessibility, or simply decreasing pain while holding an infant are all worthy goals that could be achieved through a self-management parenting program.

Project Aims

  1. To develop a four-week self-management program for parents with SCI/D to meet their needs in the parenting role and the needs of their families
  2. To aid parents with SCI/D in building the skills and resources needed to continue or begin parenting in a successful manner
  3. To disseminate the PSMP content to other regions, disability organizations, Paralyzed Veterans of America (PVA) chapters, healthcare organizations, and parenting groups to be replicated
  4. To build a sustainable format for meeting the needs of parents with SCI/D that can be replicated and continued across the U.S.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Parents/grandparents/potential parents with SCI/D had the opportunity to attend and participate in a 4 week self-management program once a week related to parenting with a disability. The self-management sessions lasted approximately 2 hours once a week and were led by an occupational therapist. There was no control group or alternate intervention.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Development of a Self- Management Program for Parents With Spinal Cord Injury and Disease
Actual Study Start Date : November 3, 2015
Actual Primary Completion Date : June 29, 2016
Actual Study Completion Date : June 29, 2016
Arms and Interventions
Arm Intervention/treatment
Parenting Self-Management Program
Participants were provided a Parenting Self -Management Program booklet with the twenty-four fact sheets at the beginning of the four-week program on topics such as adaptive babycare techniques, advocacy in the courts, emergency planning, safety in the community, talking to children about disability, managing pain/fatigue, connecting to other parents with SCI/D, and wheelchair adjustment/management during and after pregnancy. Sessions included topic introduction, participant interaction, goal setting, resource utilization, and program evaluation. Participants were allowed to choose which resources they wanted and what tips to incorporate into their parenting roles. Participants were asked to develop a weekly goal to encourage achievement, allowing individuals to identify what they wanted or decided to do that could be related to parenting directly or indirectly, such as health and wellness goals that gave them more energy or strength to complete parenting tasks.
Behavioral: Parenting Self-Management Program
Outcome Measures
Primary Outcome Measures :
  1. Change in participation using the Participation Survey- Mobility (PARTS-M) [ Time Frame: Prior to first session of the PSMP group and 4 weeks after the initial session of the PSMP group. ]
    The PARTS/M is a reliable and valid self-report survey that assesses the participation of people with mobility limitations in various life activities and the impact of common environmental factors on participation (Gray, Hollingsworth, Stark, & Morgan, 2006). For the purposes of the PSMP, a modified version of the Parenting section of the PARTS/M was used. Participants were asked how often they participate in parenting activities, their evaluation of their participation (importance, choice, satisfaction, and control), the number and value of supports they may use, and the influence of pain and fatigue on their participation in parenting activities.

  2. Change in self-efficacy using the General Self-Efficacy Scale (GSE) [ Time Frame: Prior to first session of the PSMP group and 4 weeks after the initial session of the PSMP group. ]
    The GSE was used to determine any influence of the program on participants' self-efficacy. Total score ranges from 10-40 with higher values indicating better outcome.


Secondary Outcome Measures :
  1. Demographic items [ Time Frame: Prior to first session of the PSMP group and 4 weeks after the initial session of the PSMP group as needed. ]
    Age, gender, race, marital status, education level, living situation, income, benefits received, diagnosis associated with SCI/D, time with disability, additional impairments, secondary conditions (pain & fatigue), health status, mobility device use, personal assistance use

  2. Parenting tasks [ Time Frame: Prior to first session of the PSMP group ]
    Asked about number of children, ages, ages when acquired disability and open ended questions about most important and most difficulty task, use of strategies and assistance received when children were at various stages.

  3. Skills and Knowledge [ Time Frame: Prior to first session of the PSMP group and 4 weeks after the initial session of the PSMP group. ]
    Participants were asked to rate their knowledge of topics that were going to be included in the PSMP on a 0-10 scale.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 or older, parent/guardian/grandparent with diagnosis of SCI/D, community dwelling, able to read at or above sixth grade level and either newly injured (sustained SCI in last year) or self-identified as being less experienced in their parenting role.

Exclusion Criteria:

  • Individuals were excluded if they were under age 18, did not have SCI/D, were not a parent/guardian/grandparent or lived in an institution.

A convenience sampling method was used to recruit participants through distribution of flyers at rehabilitation facilities, independent living centers and word of mouth

Contacts and Locations

Locations
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United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63108-2212
Sponsors and Collaborators
Washington University School of Medicine
Paralyzed Veterans of America
Investigators
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Principal Investigator: Jessica Dashner, OTD Washington University Program in Occupational Therapy
Tracking Information
First Submitted Date  ICMJE May 30, 2019
First Posted Date  ICMJE June 13, 2019
Last Update Posted Date June 20, 2019
Actual Study Start Date  ICMJE November 3, 2015
Actual Primary Completion Date June 29, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2019)
  • Change in participation using the Participation Survey- Mobility (PARTS-M) [ Time Frame: Prior to first session of the PSMP group and 4 weeks after the initial session of the PSMP group. ]
    The PARTS/M is a reliable and valid self-report survey that assesses the participation of people with mobility limitations in various life activities and the impact of common environmental factors on participation (Gray, Hollingsworth, Stark, & Morgan, 2006). For the purposes of the PSMP, a modified version of the Parenting section of the PARTS/M was used. Participants were asked how often they participate in parenting activities, their evaluation of their participation (importance, choice, satisfaction, and control), the number and value of supports they may use, and the influence of pain and fatigue on their participation in parenting activities.
  • Change in self-efficacy using the General Self-Efficacy Scale (GSE) [ Time Frame: Prior to first session of the PSMP group and 4 weeks after the initial session of the PSMP group. ]
    The GSE was used to determine any influence of the program on participants' self-efficacy. Total score ranges from 10-40 with higher values indicating better outcome.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
  • Demographic items [ Time Frame: Prior to first session of the PSMP group and 4 weeks after the initial session of the PSMP group as needed. ]
    Age, gender, race, marital status, education level, living situation, income, benefits received, diagnosis associated with SCI/D, time with disability, additional impairments, secondary conditions (pain & fatigue), health status, mobility device use, personal assistance use
  • Parenting tasks [ Time Frame: Prior to first session of the PSMP group ]
    Asked about number of children, ages, ages when acquired disability and open ended questions about most important and most difficulty task, use of strategies and assistance received when children were at various stages.
  • Skills and Knowledge [ Time Frame: Prior to first session of the PSMP group and 4 weeks after the initial session of the PSMP group. ]
    Participants were asked to rate their knowledge of topics that were going to be included in the PSMP on a 0-10 scale.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2019)
  • Demographic items [ Time Frame: Prior to first session of the PSMP group and 4 weeks after the initial session of the PSMP group as needed. ]
    Age, gender, race, marital status, education level, living situation, income, benefits received, diagnosis associated with SCI/D, time with disability, additional impairments, secondary conditions (pain & fatigue), health status, mobility device use, personal assistance use
  • Hope Scale [ Time Frame: Prior to first session of the PSMP group and 4 weeks after the initial session of the PSMP group. ]
    10 items on scale of "not at all true" to "exactly true".
  • Parenting tasks [ Time Frame: Prior to first session of the PSMP group ]
    Asked about number of children, ages, ages when acquired disability and open ended questions about most important and most difficulty task, use of strategies and assistance received when children were at various stages.
  • Skills and Knowledge [ Time Frame: Prior to first session of the PSMP group and 4 weeks after the initial session of the PSMP group. ]
    Participants were asked to rate their knowledge of topics that were going to be included in the PSMP on a 0-10 scale.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Development of a Self- Management Program for Parents With Spinal Cord Injury and Disease
Official Title  ICMJE Development of a Self- Management Program for Parents With Spinal Cord Injury and Disease
Brief Summary The purpose of this project was to develop and pilot test a self-management program targeted toward individuals with Spinal Cord Injury/Disease (SCI/D) who are current parents or who are considering becoming parents. This Parenting Self-Management Program (PSMP) will allow parents to identify their goals for successful family participation and provide a structure for professionals to use when working with parents with SCI/D to best meet their needs. A draft PSMP was assembled by members of the research team. This draft was reviewed by experienced parents with SCI/D and professionals who work with individuals who have SCI/D through key informant interviews or focus groups. The feedback was used to modify the draft program and the PSMP was pilot tested with a group of 10 individuals with SCI/D who are new parents, newly injured or who want to improve their participation in parenting activities.
Detailed Description

The project used a self-management approach grounded in self-efficacy theory to increase parenting self-efficacy among persons with spinal cord injury/disease (SCI/D). Program content focused on skill building through opportunities to master techniques and strategies; role modeling, problem solving, decision making, goal setting, and provision of reliable information. The use of a self-management program may also place parents with SCI/D at ease in sharing needs, as it is not an expert model by which a professional is passing judgment on their ability to care for their children. Many parents with disabilities are hesitant to seek professional services for fear of negative consequences such as losing custody of their children. Developing a program that is conducted as a partnership whereby parents direct much of the pace and content may be considered less threatening and more beneficial to those who have experienced distrust of the healthcare system.

There are no other self-management programs that specifically address the needs of parents with SCI/D. The project created a self-management program that was piloted in the St. Louis region and can be replicated across the country among other communities. While the national coordination center for families with disabilities, Through the Looking Glass, provides resource materials to parents across the country, they do not provide a structure for individual problem solving and to meet the needs of parents SCI/D on an individualized level. Providing a format for parents with SCI/D to successfully fulfill their parenting roles has a highly significant social implication; parents will be equipped to meet potential challenges and enjoy participation in their families. Limiting discrimination in the courts, seeking school accessibility, or simply decreasing pain while holding an infant are all worthy goals that could be achieved through a self-management parenting program.

Project Aims

  1. To develop a four-week self-management program for parents with SCI/D to meet their needs in the parenting role and the needs of their families
  2. To aid parents with SCI/D in building the skills and resources needed to continue or begin parenting in a successful manner
  3. To disseminate the PSMP content to other regions, disability organizations, Paralyzed Veterans of America (PVA) chapters, healthcare organizations, and parenting groups to be replicated
  4. To build a sustainable format for meeting the needs of parents with SCI/D that can be replicated and continued across the U.S.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Parents/grandparents/potential parents with SCI/D had the opportunity to attend and participate in a 4 week self-management program once a week related to parenting with a disability. The self-management sessions lasted approximately 2 hours once a week and were led by an occupational therapist. There was no control group or alternate intervention.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Spinal Cord Injuries
Intervention  ICMJE Behavioral: Parenting Self-Management Program
Study Arms  ICMJE Parenting Self-Management Program
Participants were provided a Parenting Self -Management Program booklet with the twenty-four fact sheets at the beginning of the four-week program on topics such as adaptive babycare techniques, advocacy in the courts, emergency planning, safety in the community, talking to children about disability, managing pain/fatigue, connecting to other parents with SCI/D, and wheelchair adjustment/management during and after pregnancy. Sessions included topic introduction, participant interaction, goal setting, resource utilization, and program evaluation. Participants were allowed to choose which resources they wanted and what tips to incorporate into their parenting roles. Participants were asked to develop a weekly goal to encourage achievement, allowing individuals to identify what they wanted or decided to do that could be related to parenting directly or indirectly, such as health and wellness goals that gave them more energy or strength to complete parenting tasks.
Intervention: Behavioral: Parenting Self-Management Program
Publications *
  • Gray DB, Hollingsworth HH, Stark SL, Morgan KA. Participation survey/mobility: psychometric properties of a measure of participation for people with mobility impairments and limitations. Arch Phys Med Rehabil. 2006 Feb;87(2):189-97.
  • Bodenheimer T, Lorig K, Holman H, Grumbach K. Patient self-management of chronic disease in primary care. JAMA. 2002 Nov 20;288(19):2469-75.
  • Lorig KR, Holman H. Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med. 2003 Aug;26(1):1-7. Review.
  • Lorig KR, Sobel DS, Ritter PL, Laurent D, Hobbs M. Effect of a self-management program on patients with chronic disease. Eff Clin Pract. 2001 Nov-Dec;4(6):256-62.
  • Nolte S, Elsworth GR, Sinclair AJ, Osborne RH. The extent and breadth of benefits from participating in chronic disease self-management courses: a national patient-reported outcomes survey. Patient Educ Couns. 2007 Mar;65(3):351-60. Epub 2006 Oct 5.
  • O'Toole L, Connolly D, Smith S. Impact of an occupation-based self-management programme on chronic disease management. Aust Occup Ther J. 2013 Feb;60(1):30-8. doi: 10.1111/1440-1630.12008. Epub 2012 Nov 19.
  • Signore C, Spong CY, Krotoski D, Shinowara NL, Blackwell SC. Pregnancy in women with physical disabilities. Obstet Gynecol. 2011 Apr;117(4):935-947. doi: 10.1097/AOG.0b013e3182118d59. Review.
  • Luszczynska A, Scholz U, Schwarzer R. The general self-efficacy scale: multicultural validation studies. J Psychol. 2005 Sep;139(5):439-57.
  • Barlow J, Wright C, Sheasby J, Turner A, Hainsworth J. Self-management approaches for people with chronic conditions: a review. Patient Educ Couns. 2002 Oct -Nov;48(2):177-87. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 12, 2019)
10
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 29, 2016
Actual Primary Completion Date June 29, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18 or older, parent/guardian/grandparent with diagnosis of SCI/D, community dwelling, able to read at or above sixth grade level and either newly injured (sustained SCI in last year) or self-identified as being less experienced in their parenting role.

Exclusion Criteria:

  • Individuals were excluded if they were under age 18, did not have SCI/D, were not a parent/guardian/grandparent or lived in an institution.

A convenience sampling method was used to recruit participants through distribution of flyers at rehabilitation facilities, independent living centers and word of mouth

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03985553
Other Study ID Numbers  ICMJE 201501151
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Results may be shared in the future following publication acceptance in peer reviewed journal. Individual data requests from researchers will be considered as needed at that time.
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Paralyzed Veterans of America
Investigators  ICMJE
Principal Investigator: Jessica Dashner, OTD Washington University Program in Occupational Therapy
PRS Account Washington University School of Medicine
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP