Type1diabetesType1NCT04073914
Type 1 Teamwork: A Tool for Parents of Adolescents With Type 1 Diabetes
A study testing Type 1 Teamwork Program in people with Type1diabetes and Type1 Diabetes Mellitus, run by Carelon Research at 2 sites in United States.
Trial summary
Type 1 Diabetes (T1DM) is a common chronic illness in children which presents difficult and often stressful management concerns for parents. As children approach adolescence, this burden increases with the desire for independence and self-management. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Type1diabetes, Type1 Diabetes Mellitus
- What is being tested?
- Type 1 Teamwork Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Jun 2017to 26 Mar 2018
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parent of an adolescent with T1D aged 11-16;
- Able to comply with the terms of the trial (available time commitment);
- Able to speak, read, and write in English
Who cannot join
- Not meeting inclusion criteria
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Yale University
New Haven, Connecticut, 06510
New England Research Institutes
Watertown, Massachusetts, 02472
About this study
Type 1 Diabetes (T1DM) is a common chronic illness in children which presents difficult and often stressful management concerns for parents. As children approach adolescence, this burden increases with the desire for independence and self-management. No tool exists that addresses in a user friendly, easy to access and socio-culturally appropriate way, the psychosocial needs of parents as they move through this transition. This program targets the parents to help them at the very point where this transition is occurring.
Read the detailed description
Type 1 diabetes (T1D) is one of the most common chronic illnesses in children, affecting 1 in 400,1 with evidence that its prevalence is increasing worldwide.2 The prevalence of T1D in adolescents is approximately 70% White, 22% Hispanic, and 8% Black.3-5 Parents of children with T1D are responsible for a labor-intensive and complicated daily regimen that has been described as an overwhelming experience, requiring constant vigilance.6 Intensive management of T1D requires frequent blood glucose monitoring, multiple insulin injections or use of an insulin pump, frequent alterations in insulin dose to match changing diet and activity patterns, and regular visits to health care providers. This 24/7 attention to their child's health manifests in elevated rates of parental perception of stress and increased risk for depression and anxiety. The prevalence of anxiety symptoms for parents of children with T1D range from 21-59%; depressive symptoms from 10-74%; psychological distress from 29-33%; and posttraumatic stress symptoms from 19-24%.7-9 Parental psychological distress has negative health implications for the parent, the overall functioning of the family, the psychological adjustment of their child with T1D, diabetes management, and child metabolic control.10-14 The goal of this application is to complete the psycho-educational web-based program for parents of adolescents with T1D (Type1Teamwork) which will help to: 1) decrease parental perceived stress and distress; 2) promote parental adjustment to the developmental transitions in adolescence; 3) support adolescent autonomy and transfer of diabetes responsibility from parent to adolescent; 4) decrease family conflict; and 5) maintain metabolic control during adolescence. The investigators propose to complete two major Aims in Phase II:
Specific Aim 1: Develop the Type1Teamwork program (for use on computer, tablet, or smart phone) based on the activities completed in Phase I. Six content themes have been identified as important to parents and providers. Feasibility assessment has provided support of these content themes as well as substantive recommendations to ensure content and interactivity is engaging and meets the needs of parents of children with T1D as well as health care providers. The investigators will use an iterative process of development and evaluation, collaborating with our technology team, parent advisors, and clinical consultants to ensure development of a quality product and to submit a peer reviewed manuscript for publication of the results.
Specific Aim 2: Evaluate the Type1Teamwork program through a modest randomized clinical trial. The investigators will determine the effect of the program on parent psychosocial outcomes (stress, depression, and anxiety), adolescent autonomy, parent-adolescent responsibility for T1D management, family conflict, and adolescent metabolic control. Results will be presented at diabetes meetings, published in top tier journals (to provide clinical and scientific evidence of the newly developed program), and widely disseminated per the commercialization and marketing plan.
- Conditions
- Type1diabetes, Type1 Diabetes Mellitus
- Being tested
- Type 1 Teamwork Program
- Keywords
- Diabetes, Adolescence, Parents
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type 1 Teamwork ProgramBehavioural
Psychoeducational web program
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Type 1 Teamwork program Receives: Behavioral: Type 1 Teamwork Program |
| Control | No intervention | Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Parent Stress using the Perceived Stress Scale (PSS)
Participants of the Type1Teamwork program will have a significant decrease in parent stress compared to the control arm participants at 3 and 6 month follow-up. The researchers are using the PSS, a 14-item scale that measures a person's perceived stress by considering the degree to which situations in one's life are appraised as stressful. Items evaluate how unpredictable, uncontrollable, and overloaded respondents find their lives. Higher scores indicate greater perceived stress. Chronbach's alpha was 0.89 in our sample. REF: Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. Journal of health and social behavior. Dec 1983;24(4):385-396.
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study start29 Jun 2017
- Primary completion26 Mar 2018
- Study completion26 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- To evaluate the complete program the investigators conducted a modest randomized clinical trial, randomizing parents to the Type1Teamwork program or a wait-list control group. Results were analyzed using general linear repeated measures models with training group, and time as fixed effects. The primary hypotheses comparing changes in domain totals over time will be tested by the interaction effect of time by treatment group.
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carelon Research
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University
- Responsible party
- Sponsor
- Investigators
- Lisa Marceau, MPH, Principal investigator, Carelon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04073914
- Sponsor's protocol ID
- 5R44DK098857
- Acronym
- Type1
- Status last verified
- Feb 2019
- First submitted
- 11 Mar 2019
- Last updated
- 29 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Type 1 Teamwork: A Tool for Parents of Adolescents With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04073914
- Acronym / sponsor ID
- Type1 / 5R44DK098857
- Conditions
- Type1diabetes, Type1 Diabetes Mellitus
- Keywords
- Diabetes, Adolescence, Parents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Carelon ResearchUniversity, hospital or other
- Collaborators
- Yale University
- Study start
- 29 Jun 2017 (actual)
- Primary completion
- 26 Mar 2018 (actual)
- Study completion
- 26 Mar 2018 (actual)
- First posted
- 29 Aug 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.
Type 1 Diabetes (T1DM) is a common chronic illness in children which presents difficult and often stressful management concerns for parents. As children approach adolescence, this burden increases with the desire for independence and self-management. No tool exists that addresses in a user friendly, easy to access and socio-culturally appropriate way, the psychosocial needs of parents as they move through this transition. This program targets the parents to help them at the very point where this transition is occurring.
Detailed description
Type 1 diabetes (T1D) is one of the most common chronic illnesses in children, affecting 1 in 400,1 with evidence that its prevalence is increasing worldwide.2 The prevalence of T1D in adolescents is approximately 70% White, 22% Hispanic, and 8% Black.3-5 Parents of children with T1D are responsible for a labor-intensive and complicated daily regimen that has been described as an overwhelming experience, requiring constant vigilance.6 Intensive management of T1D requires frequent blood glucose monitoring, multiple insulin injections or use of an insulin pump, frequent alterations in insulin dose to match changing diet and activity patterns, and regular visits to health care providers. This 24/7 attention to their child's health manifests in elevated rates of parental perception of stress and increased risk for depression and anxiety. The prevalence of anxiety symptoms for parents of children with T1D range from 21-59%; depressive symptoms from 10-74%; psychological distress from 29-33%; and posttraumatic stress symptoms from 19-24%.7-9 Parental psychological distress has negative health implications for the parent, the overall functioning of the family, the psychological adjustment of their child with T1D, diabetes management, and child metabolic control.10-14 The goal of this application is to complete the psycho-educational web-based program for parents of adolescents with T1D (Type1Teamwork) which will help to: 1) decrease parental perceived stress and distress; 2) promote parental adjustment to the developmental transitions in adolescence; 3) support adolescent autonomy and transfer of diabetes responsibility from parent to adolescent; 4) decrease family conflict; and 5) maintain metabolic control during adolescence. The investigators propose to complete two major Aims in Phase II:
Specific Aim 1: Develop the Type1Teamwork program (for use on computer, tablet, or smart phone) based on the activities completed in Phase I. Six content themes have been identified as important to parents and providers. Feasibility assessment has provided support of these content themes as well as substantive recommendations to ensure content and interactivity is engaging and meets the needs of parents of children with T1D as well as health care providers. The investigators will use an iterative process of development and evaluation, collaborating with our technology team, parent advisors, and clinical consultants to ensure development of a quality product and to submit a peer reviewed manuscript for publication of the results.
Specific Aim 2: Evaluate the Type1Teamwork program through a modest randomized clinical trial. The investigators will determine the effect of the program on parent psychosocial outcomes (stress, depression, and anxiety), adolescent autonomy, parent-adolescent responsibility for T1D management, family conflict, and adolescent metabolic control. Results will be presented at diabetes meetings, published in top tier journals (to provide clinical and scientific evidence of the newly developed program), and widely disseminated per the commercialization and marketing plan.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- To evaluate the complete program the investigators conducted a modest randomized clinical trial, randomizing parents to the Type1Teamwork program or a wait-list control group. Results were analyzed using general linear repeated measures models with training group, and time as fixed effects. The primary hypotheses comparing changes in domain totals over time will be tested by the interaction effect of time by treatment group.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: Type 1 Teamwork ProgramType 1 Teamwork program |
| Control | No intervention | –Standard of care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Parent of an adolescent with T1D aged 11-16;
- Able to comply with the terms of the trial (available time commitment);
- Able to speak, read, and write in English
Key exclusion criteria (1 listed)
- Not meeting inclusion criteria
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 |
|---|---|---|
| Type 1 Teamwork ProgramPsychoeducational web program | Behavioural | Intervention |
Primary outcome
Change in Parent Stress using the Perceived Stress Scale (PSS)
Time frame: Baseline, 3 months, and 6 months
Participants of the Type1Teamwork program will have a significant decrease in parent stress compared to the control arm participants at 3 and 6 month follow-up. The researchers are using the PSS, a 14-item scale that measures a person's perceived stress by considering the degree to which situations in one's life are appraised as stressful. Items evaluate how unpredictable, uncontrollable, and overloaded respondents find their lives. Higher scores indicate greater perceived stress. Chronbach's alpha was 0.89 in our sample. REF: Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. Journal of health and social behavior. Dec 1983;24(4):385-396.
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 29 Aug 2019.
- Individual participant dataSharing planned: No
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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 Marceau, MPH principal investigator
Carelon Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Type 1 Teamwork Program in people with Type1diabetes and Type1 Diabetes Mellitus, run by Carelon Research at 2 sites 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 3 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 29 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Parent Stress using the Perceived Stress Scale (PSS) (time frame: Baseline, 3 months, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2019.