Spinal Cord InjuriesNCT03985553
Development of a Self- Management Program for Parents With Spinal Cord Injury and Disease
A study testing Parenting Self-Management Program in people with Spinal Cord Injuries, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Parenting Self-Management Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2015to 29 Jun 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University
St Louis, Missouri, 63108-2212
About this study
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.
Read the 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
- 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
- To aid parents with SCI/D in building the skills and resources needed to continue or begin parenting in a successful manner
- To disseminate the PSMP content to other regions, disability organizations, Paralyzed Veterans of America (PVA) chapters, healthcare organizations, and parenting groups to be replicated
- To build a sustainable format for meeting the needs of parents with SCI/D that can be replicated and continued across the U.S.
- Conditions
- Spinal Cord Injuries
- Being tested
- Parenting Self-Management Program
- Keywords
- Parenting, Spinal Cord Injuries, Self-Management, Occupational Therapy
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenting Self-Management ProgramBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Parenting Self-Management Program | Other | 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. Receives: Behavioral: Parenting Self-Management Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in participation using the Participation Survey- Mobility (PARTS-M)
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.
Measured: Prior to first session of the PSMP group and 4 weeks after the initial session of the PSMP group.
Change in self-efficacy using the General Self-Efficacy Scale (GSE)
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.
Measured: Prior to first session of the PSMP group and 4 weeks after the initial session of the PSMP group.
Secondary outcomes (3)
Demographic items
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
Measured: Prior to first session of the PSMP group and 4 weeks after the initial session of the PSMP group as needed.
Parenting tasks
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.
Measured: Prior to first session of the PSMP group
Skills and Knowledge
Participants were asked to rate their knowledge of topics that were going to be included in the PSMP on a 0-10 scale.
Measured: Prior to first session of the PSMP group and 4 weeks after the initial session of the PSMP group.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start3 Nov 2015
- Primary completion29 Jun 2016
- Study completion29 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Paralyzed Veterans of America
- Responsible party
- Sponsor
- Investigators
- Jessica Dashner, OTD, Principal investigator, Washington University Program in Occupational Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03985553
- Sponsor's protocol ID
- 201501151
- Status last verified
- Jun 2019
- First submitted
- 30 May 2019
- Last updated
- 20 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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. doi: 10.1016/j.apmr.2005.09.014.
PubMed 16442971Bodenheimer T, Lorig K, Holman H, Grumbach K. Patient self-management of chronic disease in primary care. JAMA. 2002 Nov 20;288(19):2469-75. doi: 10.1001/jama.288.19.2469.
PubMed 12435261Lorig KR, Holman H. Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med. 2003 Aug;26(1):1-7. doi: 10.1207/S15324796ABM2601_01.
PubMed 12867348Lorig 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.
PubMed 11769298Nolte 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. doi: 10.1016/j.pec.2006.08.016. Epub 2006 Oct 5.
PubMed 17027221O'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.
PubMed 23414187Signore 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.
PubMed 21422868Luszczynska A, Scholz U, Schwarzer R. The general self-efficacy scale: multicultural validation studies. J Psychol. 2005 Sep;139(5):439-57. doi: 10.3200/JRLP.139.5.439-457.
PubMed 16285214Barlow 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. doi: 10.1016/s0738-3991(02)00032-0.
PubMed 12401421
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Self- Management Program for Parents With Spinal Cord Injury and Disease
- ClinicalTrials.gov ID
- NCT03985553
- Acronym / sponsor ID
- 201501151
- Conditions
- Spinal Cord Injuries
- Keywords
- Parenting, Spinal Cord Injuries, Self-Management, Occupational Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Paralyzed Veterans of America
- Study start
- 3 Nov 2015 (actual)
- Primary completion
- 29 Jun 2016 (actual)
- Study completion
- 29 Jun 2016 (actual)
- First posted
- 13 Jun 2019 (actual)
- 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 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
- 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
- To aid parents with SCI/D in building the skills and resources needed to continue or begin parenting in a successful manner
- To disseminate the PSMP content to other regions, disability organizations, Paralyzed Veterans of America (PVA) chapters, healthcare organizations, and parenting groups to be replicated
- 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
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Parenting Self-Management Program | Other | Behavioral: Parenting Self-Management ProgramParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Parenting Self-Management Program | Behavioural | Parenting Self-Management Program |
Primary outcome
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.
3 secondary outcomes
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.
Parenting tasks
Time frame: Prior to first session of the PSMP group
Skills and Knowledge
Time frame: Prior to first session of the PSMP group and 4 weeks after the initial session of the PSMP group.
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 20 Jun 2019.
- Background: PubMed 16442971Gray 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. doi: 10.1016/j.apmr.2005.09.014.
- Background: PubMed 12435261Bodenheimer T, Lorig K, Holman H, Grumbach K. Patient self-management of chronic disease in primary care. JAMA. 2002 Nov 20;288(19):2469-75. doi: 10.1001/jama.288.19.2469.
- Background: PubMed 12867348Lorig KR, Holman H. Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med. 2003 Aug;26(1):1-7. doi: 10.1207/S15324796ABM2601_01.
- Background: PubMed 11769298Lorig 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.
- Background: PubMed 17027221Nolte 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. doi: 10.1016/j.pec.2006.08.016. Epub 2006 Oct 5.
- Background: PubMed 23414187O'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.
- Background: PubMed 21422868Signore 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.
- Background: PubMed 16285214Luszczynska A, Scholz U, Schwarzer R. The general self-efficacy scale: multicultural validation studies. J Psychol. 2005 Sep;139(5):439-57. doi: 10.3200/JRLP.139.5.439-457.
- Background: PubMed 12401421Barlow 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. doi: 10.1016/s0738-3991(02)00032-0.
- Individual participant dataSharing planned: No. 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.
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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.
Jessica Dashner, OTD principal investigator
Washington University Program in Occupational Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parenting Self-Management Program in people with Spinal Cord Injuries, run by Washington University School of Medicine 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 1 inclusion and 2 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 20 Jun 2019. 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 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?
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 study lists 2 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 NCT03985553, which also lists 9 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 20 Jun 2019.