| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Spinal Cord Injuries | Behavioral: Parenting Self-Management Program | Not Applicable |
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
| 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 |
| 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.
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Behavioral: Parenting Self-Management Program |
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
A convenience sampling method was used to recruit participants through distribution of flyers at rehabilitation facilities, independent living centers and word of mouth
| United States, Missouri | |
| Washington University | |
| Saint Louis, Missouri, United States, 63108-2212 | |
| 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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| 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
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| 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 |
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| 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
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
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:
Exclusion Criteria:
A convenience sampling method was used to recruit participants through distribution of flyers at rehabilitation facilities, independent living centers and word of mouth |
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| Sex/Gender ICMJE |
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| 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 |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Washington University School of Medicine | ||||
| Study Sponsor ICMJE | Washington University School of Medicine | ||||
| Collaborators ICMJE | Paralyzed Veterans of America | ||||
| Investigators ICMJE |
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| PRS Account | Washington University School of Medicine | ||||
| Verification Date | June 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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