Diabetes Mellitus, Type 1NCT02527525
First STEPS- Study of Type 1 in Early Childhood and Parenting Support
A study testing Stepped Care in people with Diabetes Mellitus, Type 1, run by Children's National Research Institute.
Trial summary
The incidence of type 1 diabetes (T1D) in young children (age <6 years) is rising. Disease management guidelines offered by the ADA and other diabetes care organizations place a high burden of responsibility onto these children's parents and caregivers to check blood sugar, administer insulin, and monitor diet and… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Stepped Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Jul 2021
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary caregivers for children ages 1-6 newly diagnosed with T1D
- Although we anticipate that the majority (90%) of primary caregivers will be female (e.g., mothers, grandmothers), we will include males who self-identify as the primary caregiver (e.g., fathers).
- Parents of children following all types of medical regimens, with any level of glycemic control, will be invited to participate.
- Parents must be able to adequately understand, speak, and read English to benefit from participation. Parents must have ready and consistent access to a mobile telephone with text messaging capability to participate.
Who cannot join
- Parent non-english speaking.
- Parents are the focus of this investigation and, therefore, cannot have serious mental illness (e.g., schizophrenia) or developmental disability that would limit participation. Similarly, children with T1D should not have other life-threatening disease (e.g., cancer, cystic fibrosis) or developmental disability (e.g., autism, mental retardation).
About this study
Official title: A Stepped Care Behavioral Intervention Trial for Young Children With T1D
The incidence of type 1 diabetes (T1D) in young children (age <6 years) is rising. Disease management guidelines offered by the ADA and other diabetes care organizations place a high burden of responsibility onto these children's parents and caregivers to check blood sugar, administer insulin, and monitor diet and physical activity to maintain tight glycemic control. Unfortunately, this occurs at a vulnerable time in life when children's behavior is unpredictable, their T1D is difficult to control, parenting stress is elevated, and caregivers are strained by normal child caretaking routines. T1D education and support tends to be highly concentrated at diagnosis/during the inpatient stay, and requires rapid knowledge and skill acquisition on the part of parents. Not all families respond equally well to this teaching model, and many need more guided practice, problem-solving assistance, and behavioral supports than can be offered in a one-size-fits-all patient education approach. Our research will attempt to better meet the needs of individual families through a clinical behavioral stepped care intervention for T1D in parents of young children by using real-time glycemic control and [parental depression indices] to intensify management support when indicated. Primary caregivers of young children (<6 years) newly diagnosed with T1D will be randomized to either a 3-step stepped care (treatment) or usual care (comparison) condition. Stepped care components include: T1D management support delivered by trained lay parent consultants (Step 1), T1D parenting strategies and mealtime behavior management delivered by bachelor's level behavioral assistants (Step 2), and individualized diabetes education/management planning with a certified diabetes nurse educator and [consultation with a diabetes team clinical psychologist] (Step 3). Biomedical and psychosocial measurements (including A1c, depressive symptoms, mealtime behavior, parenting stress, quality of life) will occur at baseline and 3-month intervals for up to 15 months post-diagnosis. The results of this work will ultimately lead to a more practical approach to T1D education and management that can be translated more easily into a variety of clinical practice settings to support young children's T1D management.
Read the detailed description
Research Design and Methods Overview of Study Design \& Procedure. The aim of this randomized controlled trial (RCT) is to determine the efficacy of a stepped care intervention that provides participants with up to 3 intensity levels, or steps, of clinical behavioral intervention support to help manage young children's newly diagnosed type 1 diabetes (T1D), compared to usual care. We expect that children of families allocated to the intervention condition (First STEPS) will have better glycemic outcomes, better parent psychosocial functioning, and fewer behavior problems, including negative mealtime behaviors. A total of 200 parents will be randomly allocated in a 3:1 ratio to be treated with either First STEPS (n=150) or usual care (n=50; COMPARISON condition): all participants receive standard diabetes education as part of usual care in both conditions. Our intervention is intended to be delivered by trained peer parent coaches (Step 1), bachelor's or master's prepared research educators (Step 2), and RN or master's level certified diabetes educators and PhD level clinical psychologist (Step 3).
For Step 1 we are employing the use of parent coaches as a low-cost highly translatable intervention that parents in our pilot study reported to be extremely helpful following the time of diagnosis. For Step 2 the research educators will build upon support provided by parent coaches, and will implement our 5 telephone session behavioral intervention that provides cognitive behavioral strategies to support parents in their daily management of T1D, while at the same time targets parental mood and specifically symptoms of depression. Step 3 engages certified diabetes educators and the diabetes team clinical psychologist and allows for more intensive review of the child's medical regimen and targets potential changes. The clinical psychologist consultation addresses how symptoms of parental depression may interfere with caring for the child's diabetes, and will refer for further treatment if needed. Intervention content, training, and fidelity for each intervention step are described below. Participants are evaluated at baseline (at diagnosis, pre-random allocation) and follow-up (3-, 6-, 9-, 12-, and 15-months post-diagnosis). These steps are sequentially designed to systematically build expertise and intensity.
Participants. 200 self-identified primary caregivers for children ages 1-6 newly diagnosed with T1D (50% female) will be enrolled at 2 trial sites in (1) Washington, DC (Children's National Medical Center; CNMC), and (2) Houston, Texas (Texas Children's Hospital; TCH). T1D affects approximately 1 in 500 children, and although its incidence is increasing, numbers of available children for study are still much lower than for other illnesses including type 2 diabetes. The investigators have therefore decided to have 2 sites for adequate power for this study. Although the investigators anticipate that the majority (90%) of primary caregivers will be female (e.g., mothers, grandmothers), males who self-identify as the primary caregiver (e.g., fathers) will also be included.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Stepped Care
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepped CareBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Stepped Care | Experimental | 150 subjects will be randomized to the stepped care intervention. All 150 participants will be assigned a parent coach after randomization to stepped care condition. At the child's next follow up clinic visit participants who have elevated depression scores OR who's child has not met A1c target will move on to Step 2 of the intervention- 5 sessions with a study interventionist. At the following child's clinic visit, participants can either remain in Step 1, move to Step 2, or if needed, move on to Step 3- using a continuous glucose monitor for 1 week followed by a meeting with a certified diabetes educator and a diabetes team clinical psychologist. Receives: Behavioral: Stepped Care |
| Usual Care | No intervention | Participants randomized to usual care will participate in regular diabetes clinic visits and diabetes education, as they would have done without participation in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
glycemic control
A1c
Measured: 6 months post intervention completion
parental mood
parent report on CES-D
Measured: 6 months post intervention completion
glycemic variability
data from 30 day blood glucose download will be summarized to characterize percent of time above, below, and within target range
Measured: 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startApr 2016
- Primary completionJul 2021
- Study completionJul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Children's National Research InstituteThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor College of Medicine, National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Randi Streisand, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02527525
- Sponsor's protocol ID
- 6270
- Other IDs
- 1R01DK102561-01A1
- Status last verified
- Aug 2021
- First submitted
- 16 Aug 2015
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hilliard ME, Tully C, Monaghan M, Hildebrandt T, Wang CH, Barber JR, Clary L, Gallagher K, Levy W, Cogen F, Henderson C, Karaviti L, Streisand R. First STEPS: Primary Outcomes of a Randomized, Stepped-Care Behavioral Clinical Trial for Parents of Young Children With New-Onset Type 1 Diabetes. Diabetes Care. 2022 Oct 1;45(10):2238-2246. doi: 10.2337/dc21-2704.
PubMed 35997261Wang CH, Hilliard ME, Carreon SA, Jones J, Rooney K, Barber JR, Tully C, Monaghan M, Streisand R. Predictors of mood, diabetes-specific and COVID-19-specific experiences among parents of early school-age children with type 1 diabetes during initial months of the COVID-19 pandemic. Pediatr Diabetes. 2021 Nov;22(7):1071-1080. doi: 10.1111/pedi.13255. Epub 2021 Aug 30.
PubMed 34369043Sinisterra M, Wang CH, Marks BE, Barber J, Tully C, Monaghan M, Hilliard ME, Streisand R. Patterns of Continuous Glucose Monitor Use in Young Children Throughout the First 18 Months Following Type 1 Diabetes Diagnosis. Diabetes Technol Ther. 2021 Nov;23(11):777-781. doi: 10.1089/dia.2021.0183. Epub 2021 Jul 29.
PubMed 34252292Shneider C, Hilliard ME, Monaghan M, Tully C, Wang CH, Sinisterra M, Jones J, Levy W, Streisand R. Recruiting and retaining parents in behavioral intervention trials: Strategies to consider. Contemp Clin Trials. 2021 Sep;108:106502. doi: 10.1016/j.cct.2021.106502. Epub 2021 Jul 6.
PubMed 34237457
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Stepped Care Behavioral Intervention Trial for Young Children With T1D
- ClinicalTrials.gov ID
- NCT02527525
- Acronym / sponsor ID
- 6270
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Collaborators
- Baylor College of Medicine, National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Apr 2016
- Primary completion
- Jul 2021 (actual)
- Study completion
- Jul 2021 (actual)
- First posted
- 19 Aug 2015 (estimated)
- 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 incidence of type 1 diabetes (T1D) in young children (age <6 years) is rising. Disease management guidelines offered by the ADA and other diabetes care organizations place a high burden of responsibility onto these children's parents and caregivers to check blood sugar, administer insulin, and monitor diet and physical activity to maintain tight glycemic control. Unfortunately, this occurs at a vulnerable time in life when children's behavior is unpredictable, their T1D is difficult to control, parenting stress is elevated, and caregivers are strained by normal child caretaking routines. T1D education and support tends to be highly concentrated at diagnosis/during the inpatient stay, and requires rapid knowledge and skill acquisition on the part of parents. Not all families respond equally well to this teaching model, and many need more guided practice, problem-solving assistance, and behavioral supports than can be offered in a one-size-fits-all patient education approach. Our research will attempt to better meet the needs of individual families through a clinical behavioral stepped care intervention for T1D in parents of young children by using real-time glycemic control and [parental depression indices] to intensify management support when indicated. Primary caregivers of young children (<6 years) newly diagnosed with T1D will be randomized to either a 3-step stepped care (treatment) or usual care (comparison) condition. Stepped care components include: T1D management support delivered by trained lay parent consultants (Step 1), T1D parenting strategies and mealtime behavior management delivered by bachelor's level behavioral assistants (Step 2), and individualized diabetes education/management planning with a certified diabetes nurse educator and [consultation with a diabetes team clinical psychologist] (Step 3). Biomedical and psychosocial measurements (including A1c, depressive symptoms, mealtime behavior, parenting stress, quality of life) will occur at baseline and 3-month intervals for up to 15 months post-diagnosis. The results of this work will ultimately lead to a more practical approach to T1D education and management that can be translated more easily into a variety of clinical practice settings to support young children's T1D management.
Detailed description
Research Design and Methods Overview of Study Design \& Procedure. The aim of this randomized controlled trial (RCT) is to determine the efficacy of a stepped care intervention that provides participants with up to 3 intensity levels, or steps, of clinical behavioral intervention support to help manage young children's newly diagnosed type 1 diabetes (T1D), compared to usual care. We expect that children of families allocated to the intervention condition (First STEPS) will have better glycemic outcomes, better parent psychosocial functioning, and fewer behavior problems, including negative mealtime behaviors. A total of 200 parents will be randomly allocated in a 3:1 ratio to be treated with either First STEPS (n=150) or usual care (n=50; COMPARISON condition): all participants receive standard diabetes education as part of usual care in both conditions. Our intervention is intended to be delivered by trained peer parent coaches (Step 1), bachelor's or master's prepared research educators (Step 2), and RN or master's level certified diabetes educators and PhD level clinical psychologist (Step 3).
For Step 1 we are employing the use of parent coaches as a low-cost highly translatable intervention that parents in our pilot study reported to be extremely helpful following the time of diagnosis. For Step 2 the research educators will build upon support provided by parent coaches, and will implement our 5 telephone session behavioral intervention that provides cognitive behavioral strategies to support parents in their daily management of T1D, while at the same time targets parental mood and specifically symptoms of depression. Step 3 engages certified diabetes educators and the diabetes team clinical psychologist and allows for more intensive review of the child's medical regimen and targets potential changes. The clinical psychologist consultation addresses how symptoms of parental depression may interfere with caring for the child's diabetes, and will refer for further treatment if needed. Intervention content, training, and fidelity for each intervention step are described below. Participants are evaluated at baseline (at diagnosis, pre-random allocation) and follow-up (3-, 6-, 9-, 12-, and 15-months post-diagnosis). These steps are sequentially designed to systematically build expertise and intensity.
Participants. 200 self-identified primary caregivers for children ages 1-6 newly diagnosed with T1D (50% female) will be enrolled at 2 trial sites in (1) Washington, DC (Children's National Medical Center; CNMC), and (2) Houston, Texas (Texas Children's Hospital; TCH). T1D affects approximately 1 in 500 children, and although its incidence is increasing, numbers of available children for study are still much lower than for other illnesses including type 2 diabetes. The investigators have therefore decided to have 2 sites for adequate power for this study. Although the investigators anticipate that the majority (90%) of primary caregivers will be female (e.g., mothers, grandmothers), males who self-identify as the primary caregiver (e.g., fathers) will also be included.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stepped Care | Experimental | Behavioral: Stepped Care150 subjects will be randomized to the stepped care intervention. All 150 participants will be assigned a parent coach after randomization to stepped care condition. At the child's next follow up clinic visit participants who have elevated depression scores OR who's child has not met A1c target will move on to Step 2 of the intervention- 5 sessions with a study interventionist. At the following child's clinic visit, participants can either remain in Step 1, move to Step 2, or if needed, move on to Step 3- using a continuous glucose monitor for 1 week followed by a meeting with a certified diabetes educator and a diabetes team clinical psychologist. |
| Usual Care | No intervention | –Participants randomized to usual care will participate in regular diabetes clinic visits and diabetes education, as they would have done without participation in this study. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary caregivers for children ages 1-6 newly diagnosed with T1D
- Although we anticipate that the majority (90%) of primary caregivers will be female (e.g., mothers, grandmothers), we will include males who self-identify as the primary caregiver (e.g., fathers).
- Parents of children following all types of medical regimens, with any level of glycemic control, will be invited to participate.
- Parents must be able to adequately understand, speak, and read English to benefit from participation. Parents must have ready and consistent access to a mobile telephone with text messaging capability to participate.
Key exclusion criteria (2 listed)
- Parent non-english speaking.
- Parents are the focus of this investigation and, therefore, cannot have serious mental illness (e.g., schizophrenia) or developmental disability that would limit participation. Similarly, children with T1D should not have other life-threatening disease (e.g., cancer, cystic fibrosis) or developmental disability (e.g., autism, mental retardation).
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 |
|---|---|---|
| Stepped Care | Behavioural | Stepped Care |
Primary outcome
glycemic control
Time frame: 6 months post intervention completion
A1c
parental mood
Time frame: 6 months post intervention completion
parent report on CES-D
glycemic variability
Time frame: 6 months post intervention
data from 30 day blood glucose download will be summarized to characterize percent of time above, below, and within target range
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 6 Aug 2021.
- Derived from this study: PubMed 35997261Hilliard ME, Tully C, Monaghan M, Hildebrandt T, Wang CH, Barber JR, Clary L, Gallagher K, Levy W, Cogen F, Henderson C, Karaviti L, Streisand R. First STEPS: Primary Outcomes of a Randomized, Stepped-Care Behavioral Clinical Trial for Parents of Young Children With New-Onset Type 1 Diabetes. Diabetes Care. 2022 Oct 1;45(10):2238-2246. doi: 10.2337/dc21-2704.
- Derived from this study: PubMed 34369043Wang CH, Hilliard ME, Carreon SA, Jones J, Rooney K, Barber JR, Tully C, Monaghan M, Streisand R. Predictors of mood, diabetes-specific and COVID-19-specific experiences among parents of early school-age children with type 1 diabetes during initial months of the COVID-19 pandemic. Pediatr Diabetes. 2021 Nov;22(7):1071-1080. doi: 10.1111/pedi.13255. Epub 2021 Aug 30.
- Derived from this study: PubMed 34252292Sinisterra M, Wang CH, Marks BE, Barber J, Tully C, Monaghan M, Hilliard ME, Streisand R. Patterns of Continuous Glucose Monitor Use in Young Children Throughout the First 18 Months Following Type 1 Diabetes Diagnosis. Diabetes Technol Ther. 2021 Nov;23(11):777-781. doi: 10.1089/dia.2021.0183. Epub 2021 Jul 29.
- Derived from this study: PubMed 34237457Shneider C, Hilliard ME, Monaghan M, Tully C, Wang CH, Sinisterra M, Jones J, Levy W, Streisand R. Recruiting and retaining parents in behavioral intervention trials: Strategies to consider. Contemp Clin Trials. 2021 Sep;108:106502. doi: 10.1016/j.cct.2021.106502. Epub 2021 Jul 6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Stepped Care in people with Diabetes Mellitus, Type 1, run by Children's National Research Institute.
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 4 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 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
glycemic control (time frame: 6 months post intervention completion). The study lists 3 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 NCT02527525, which also lists 4 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 6 Aug 2021.