Type 1 DiabetesYCPNCT00847327
Parental Management of Young Children's Diabetes
A study testing Parental Support and Diabetes Education in people with Type 1 Diabetes, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 2 sites in United States.
Trial summary
Type 1 diabetes is a lifelong metabolic disorder that affects 1 out of every 400-600 American children each year, with many children being diagnosed at younger and younger ages. To achieve proper diabetes control, it is necessary to conform or adhere one's behavior to a physician-prescribed diabetes self-care regimen. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Parental Support and Diabetes Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2008to Aug 2013
- 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 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Type 1 diabetes for at least 6 months prior to enrollment
- Seen for diabetes care at Children's National or Virginia Commonwealth
- Child ages 1-6
Who cannot join
- Non-English speaking primary caregiver
- Child with significant developmental delay
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Virginia Commonwealth University
Richmond, Virginia, 23284
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Parenting and Control Among Young Children With Type 1 Diabetes
Type 1 diabetes is a lifelong metabolic disorder that affects 1 out of every 400-600 American children each year, with many children being diagnosed at younger and younger ages.
To achieve proper diabetes control, it is necessary to conform or adhere one's behavior to a physician-prescribed diabetes self-care regimen. As such, parents of children with Type 1 diabetes must be highly involved in managing their child's disease on a daily basis, especially parents of affected children who are very young and more highly dependent upon parental caretaking.
Read more
As children diagnosed with Type 1 diabetes at a very young age may be at an increased risk for the development of long-term behavioral and medical complications, more research is needed to understand and treat the leading contributors to diabetes-related parental distress and medical outcomes among this growing subgroup.
Recent findings indicate that responsibility for diabetes management falls heavily on mothers. The majority of families do not receive outside child care assistance and report feeling overwhelmed. Parents report high levels of pediatric parenting stress difficulty, as well as moderate symptoms of anxiety. The current study aims to expand such preliminary findings and specifically examine the effects of a newly-developed parenting support program for parents of young children with Type 1 diabetes. The utility of the intervention will be evaluated. It is hypothesized that parents completing the parent support program will report lower levels of psychosocial distress and improved quality of life. It is hypothesized that the children of participating parents will also demonstrate improved quality of life and metabolic control.
Read the detailed description
Type 1 diabetes is a lifelong metabolic disorder that affects 1 out of every 400-600 American children each year, with many children being diagnosed at younger and younger ages. If Type 1 diabetes is not properly controlled, it can lead to a host of devastating disease-related complications later in life. Therefore, achieving proper diabetes control during childhood is an important public health issue.
To achieve proper diabetes control, it is necessary to conform or adhere one's behavior to a physician-prescribed diabetes self-care regimen consisting of multiple insulin administrations and blood glucose (BG) checks daily, as well as pay careful attention to diet and exercise. As such, parents of children with Type 1 diabetes must be highly involved in managing their child's disease on a daily basis, especially parents of affected children who are very young and more highly dependent upon parental caretaking.
It is not surprising that the experience of managing a child's diabetes can be demanding, overwhelming, and stressful for some parents, and may even significantly impair parental psychosocial well being. Further, difficulties achieving proper diabetes control have been reported to occur among parents of children of all ages, including parents of those who are very young.
Operationally, these psychosocial well being and diabetes outcomes can be examined by assessing: (1) parental symptoms of depression, anxiety, diabetes parenting stress, and perceived social support, and (2) metabolic control, which may be measured with the quarterly HbA1C counts.
As children diagnosed with Type 1 diabetes at a very young age may be at an increased risk for the development of long-term behavioral and medical complications due to the aforementioned difficulties (on the part of their parents), more research is needed to understand and treat the leading contributors to diabetes-related parental distress (depression, anxiety, stress, social support) and medical outcomes among this growing subgroup.
Recent findings indicate that responsibility for diabetes management falls heavily on mothers, who report performing 79% of their children's injections and 70% of blood glucose checks (Mednick, 2005). The majority of families do not receive outside child care assistance and report feeling overwhelmed. Parents report high levels of pediatric parenting stress difficulty, as well as moderate symptoms of anxiety. The current study aims to expand such preliminary findings and specifically examine the effects of a newly-developed parenting support program for parents of young children with Type 1 diabetes. The utility of the intervention will be evaluated. It is hypothesized that parents completing the parent support program will report lower levels of psychosocial distress and improved quality of life. It is hypothesized that the children of participating parents will also demonstrate improved quality of life and metabolic control.
Evaluating this intervention is a first step in the long-term goal of improving diabetes health outcomes for young children. Understanding the usefulness of this intervention can help us to further refine intervention programs for parents of young children with Type 1 diabetes that best meet their unique needs and risks.
- Conditions
- Type 1 Diabetes
- Being tested
- Parental Support, Diabetes Education
- Keywords
- Type 1 Diabetes, Parenting, Young Children
- 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.
Parental SupportBehavioural
Also called Cognitive Behavioral Strategies, Parent Support
The intervention utilizes cognitive behavioral strategies. Session 1 uses relaxation and cognitive reframing and explores parents' responses to the challenges of parenting a child with diabetes. Session 2 focuses on the emotional impact of having a child with diabetes and utilizes problem solving techniques. Session 3 focuses on child behavior and strategies for effective parenting. To facilitate support and community, Session 4 is a group session via conference call to discuss issues related to social support. Session 5 focuses on the impact diabetes has on the family and parents are taught cognitive reframing to help with managing diabetes. Parents are invited to participate in an Internet bulletin board moderated by trial personnel.
Diabetes EducationBehavioural
Also called Diabetes Management, Nutrition, Exercise
The education comparison group also participates in 5 sessions across 9 weeks. This group provides educational and resource support that is specific to managing diabetes in young children. Education topics include blood glucose monitoring, nutrition, and physical activity. Print materials are provided to participants and intervention sessions focus on talking points raised in these reading materials.
| Study group | Role | What they receive |
|---|---|---|
| Parental Support | Experimental | Not described Receives: Behavioral: Parental Support |
| Diabetes Education | Active comparator | Not described Receives: Behavioral: Diabetes Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic variability
Measured: baseline, 1, 6, and 12 months post intervention
Secondary outcomes (3)
Parent Quality of Life
Measured: baseline, 1, 6, and 12 months post intervention
Child Quality of Life
Measured: baseline, 1, 6, and 12 months post intervention
Hemoglobin A1C
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 Feb 2009 (estimated)
- Study startApr 2008
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Randi Streisand, Ph.D., Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00847327
- Sponsor's protocol ID
- DK80102
- Other IDs
- R01DK080102
- Acronym
- YCP
- Status last verified
- Mar 2018
- First submitted
- 17 Feb 2009
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parenting and Control Among Young Children With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT00847327
- Acronym / sponsor ID
- YCP / DK80102
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes, Parenting, Young Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Collaborators
- Children's National Research Institute, Virginia Commonwealth University
- Study start
- Apr 2008 (actual)
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 19 Feb 2009 (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.
Type 1 diabetes is a lifelong metabolic disorder that affects 1 out of every 400-600 American children each year, with many children being diagnosed at younger and younger ages.
To achieve proper diabetes control, it is necessary to conform or adhere one's behavior to a physician-prescribed diabetes self-care regimen. As such, parents of children with Type 1 diabetes must be highly involved in managing their child's disease on a daily basis, especially parents of affected children who are very young and more highly dependent upon parental caretaking.
As children diagnosed with Type 1 diabetes at a very young age may be at an increased risk for the development of long-term behavioral and medical complications, more research is needed to understand and treat the leading contributors to diabetes-related parental distress and medical outcomes among this growing subgroup.
Recent findings indicate that responsibility for diabetes management falls heavily on mothers. The majority of families do not receive outside child care assistance and report feeling overwhelmed. Parents report high levels of pediatric parenting stress difficulty, as well as moderate symptoms of anxiety. The current study aims to expand such preliminary findings and specifically examine the effects of a newly-developed parenting support program for parents of young children with Type 1 diabetes. The utility of the intervention will be evaluated. It is hypothesized that parents completing the parent support program will report lower levels of psychosocial distress and improved quality of life. It is hypothesized that the children of participating parents will also demonstrate improved quality of life and metabolic control.
Detailed description
Type 1 diabetes is a lifelong metabolic disorder that affects 1 out of every 400-600 American children each year, with many children being diagnosed at younger and younger ages. If Type 1 diabetes is not properly controlled, it can lead to a host of devastating disease-related complications later in life. Therefore, achieving proper diabetes control during childhood is an important public health issue.
To achieve proper diabetes control, it is necessary to conform or adhere one's behavior to a physician-prescribed diabetes self-care regimen consisting of multiple insulin administrations and blood glucose (BG) checks daily, as well as pay careful attention to diet and exercise. As such, parents of children with Type 1 diabetes must be highly involved in managing their child's disease on a daily basis, especially parents of affected children who are very young and more highly dependent upon parental caretaking.
It is not surprising that the experience of managing a child's diabetes can be demanding, overwhelming, and stressful for some parents, and may even significantly impair parental psychosocial well being. Further, difficulties achieving proper diabetes control have been reported to occur among parents of children of all ages, including parents of those who are very young.
Operationally, these psychosocial well being and diabetes outcomes can be examined by assessing: (1) parental symptoms of depression, anxiety, diabetes parenting stress, and perceived social support, and (2) metabolic control, which may be measured with the quarterly HbA1C counts.
As children diagnosed with Type 1 diabetes at a very young age may be at an increased risk for the development of long-term behavioral and medical complications due to the aforementioned difficulties (on the part of their parents), more research is needed to understand and treat the leading contributors to diabetes-related parental distress (depression, anxiety, stress, social support) and medical outcomes among this growing subgroup.
Recent findings indicate that responsibility for diabetes management falls heavily on mothers, who report performing 79% of their children's injections and 70% of blood glucose checks (Mednick, 2005). The majority of families do not receive outside child care assistance and report feeling overwhelmed. Parents report high levels of pediatric parenting stress difficulty, as well as moderate symptoms of anxiety. The current study aims to expand such preliminary findings and specifically examine the effects of a newly-developed parenting support program for parents of young children with Type 1 diabetes. The utility of the intervention will be evaluated. It is hypothesized that parents completing the parent support program will report lower levels of psychosocial distress and improved quality of life. It is hypothesized that the children of participating parents will also demonstrate improved quality of life and metabolic control.
Evaluating this intervention is a first step in the long-term goal of improving diabetes health outcomes for young children. Understanding the usefulness of this intervention can help us to further refine intervention programs for parents of young children with Type 1 diabetes that best meet their unique needs and risks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parental Support | Experimental | Behavioral: Parental Support |
| Diabetes Education | Active comparator | Behavioral: Diabetes Education |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Type 1 diabetes for at least 6 months prior to enrollment
- Seen for diabetes care at Children's National or Virginia Commonwealth
- Child ages 1-6
Key exclusion criteria (2 listed)
- Non-English speaking primary caregiver
- Child with significant developmental delay
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 |
|---|---|---|
| Parental SupportAlso: Cognitive Behavioral Strategies, Parent SupportThe intervention utilizes cognitive behavioral strategies. Session 1 uses relaxation and cognitive reframing and explores parents' responses to the challenges of parenting a child with diabetes. Session 2 focuses on the emotional impact of having a child with diabetes and utilizes problem solving techniques. Session 3 focuses on child behavior and strategies for effective parenting. To facilitate support and community, Session 4 is a group session via conference call to discuss issues related to social support. Session 5 focuses on the impact diabetes has on the family and parents are taught cognitive reframing to help with managing diabetes. Parents are invited to participate in an Internet bulletin board moderated by trial personnel. | Behavioural | Parental Support |
| Diabetes EducationAlso: Diabetes Management, Nutrition, ExerciseThe education comparison group also participates in 5 sessions across 9 weeks. This group provides educational and resource support that is specific to managing diabetes in young children. Education topics include blood glucose monitoring, nutrition, and physical activity. Print materials are provided to participants and intervention sessions focus on talking points raised in these reading materials. | Behavioural | Diabetes Education |
Primary outcome
Glycemic variability
Time frame: baseline, 1, 6, and 12 months post intervention
3 secondary outcomes
Parent Quality of Life
Time frame: baseline, 1, 6, and 12 months post intervention
Child Quality of Life
Time frame: baseline, 1, 6, and 12 months post intervention
Hemoglobin A1C
Time frame: 6 months post intervention
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 14 Mar 2018.
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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.
Randi Streisand, Ph.D. principal investigator
Children's National Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parental Support and Diabetes Education in people with Type 1 Diabetes, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 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 14 Mar 2018. 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?
Glycemic variability (time frame: baseline, 1, 6, and 12 months post intervention). 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 14 Mar 2018.