Type 1 Diabetes MellitusNCT00439985
Improving Metabolic Control in Diabetic Young Children
A study testing Cognitive Behavioral Therapy in people with Type 1 Diabetes Mellitus, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
: Although intervention or prevention with young children with T1DM may help ameliorate problems or forestall later problems in metabolic control, a number of potential barriers to research have constrained the development of such interventions. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Jul 2009
- 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 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 7 to 11
- Recently diagnosed with T1DM
- Treated at Mount Sinai or at North General Hospital
Who cannot join
- Children below age 7 and above age 11
- Individual with diminished mental capacity, such that they would not be able to either complete the assessments or comprehend the materials presented in the intervention, will be excluded.
- Individuals without sufficient command of the English language to permit participation (due to the verbal nature of the intervention and the assessment package, and the linguistic limitations of the study team).
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai School of Medicine
New York, New York, 10029-6574
About this study
: Although intervention or prevention with young children with T1DM may help ameliorate problems or forestall later problems in metabolic control, a number of potential barriers to research have constrained the development of such interventions. To assess the feasibility of intervening with young children and their families, we propose to conduct an exploratory pilot study of a behavioral intervention for young children (ages 7 to 11) newly diagnosed with T1DM. The intervention, derived from the pediatric prevention work of Seligman and his colleagues, seeks to apply positive psychology principles to enhance optimism, self-efficacy, and parent-child collaboration in diabetes management, in order to improve quality of life, adherence, and metabolic control. This exploratory study will allow us to evaluate the feasibility of intervening with young children and their caretakers and to estimate intervention effect sizes in preparation for a randomized controlled clinical trial.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Cognitive Behavioral Therapy
- Keywords
- Type 1 Diabetes Mellitus (T1DM), Metabolic Control, Adherence, Optimism, Parent-Child Collaboration, Prevention
- 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.
Cognitive Behavioral TherapyBehavioural
The treatment which incorporates cognitive restructuring and skill training, was designed to help children with diabetes and their families develop particular skills and optimistic/positive thinking style in order to facilitate better coping with the enduring demands and stress of diabetes management. The goal of the intervention was to improve the child's diabetes management both medically and psychologically by promoting optimism (positive outlook), mastery (problem-solving) and child-parent collaboration (team-work).
| Study group | Role | What they receive |
|---|---|---|
| Behavioral: Cognitive Behavior Therapy | Other | Not described Receives: Behavioral: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
adherence
Measured: at baseline
adherence
Measured: at 3 months
adherence
Measured: at 6 months
adherence
Measured: at 9 months
quality of life
Measured: at baseline
quality of life
Measured: at 3 months
quality of life
Measured: at 6 months
quality of life
Measured: at 9 months
Secondary outcomes (12)
optimism
Measured: at baseline
optimism
Measured: at 3 months
optimism
Measured: at 6 months
optimism
Measured: at 9 months
self-efficacy
Measured: at baseline
self-efficacy
Measured: at 3 months
self-efficacy
Measured: at 6 months
self-efficacy
Measured: at 9 months
parent-child collaboration
Measured: at baseline
parent-child collaboration
Measured: at 3 months
parent-child collaboration
Measured: at 6 months
parent-child collaboration
Measured: at 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2007 (estimated)
- Study startSep 2006
- Primary completionJul 2009
- Study completionJul 2009
Why it stopped: decreased enrollment. (there are no data results for this study)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Investigators
- Claude Chemtob, Ph.D., Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00439985
- Sponsor's protocol ID
- DK074580
- Other IDs
- 05-0667
- Status last verified
- Jun 2011
- First submitted
- 23 Feb 2007
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Metabolic Control in Diabetic Young Children
- ClinicalTrials.gov ID
- NCT00439985
- Acronym / sponsor ID
- DK074580
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type 1 Diabetes Mellitus (T1DM), Metabolic Control, Adherence, Optimism, Parent-Child Collaboration, Prevention
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: decreased enrollment. (there are no data results for this study)
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 26 Feb 2007 (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.
: Although intervention or prevention with young children with T1DM may help ameliorate problems or forestall later problems in metabolic control, a number of potential barriers to research have constrained the development of such interventions. To assess the feasibility of intervening with young children and their families, we propose to conduct an exploratory pilot study of a behavioral intervention for young children (ages 7 to 11) newly diagnosed with T1DM. The intervention, derived from the pediatric prevention work of Seligman and his colleagues, seeks to apply positive psychology principles to enhance optimism, self-efficacy, and parent-child collaboration in diabetes management, in order to improve quality of life, adherence, and metabolic control. This exploratory study will allow us to evaluate the feasibility of intervening with young children and their caretakers and to estimate intervention effect sizes in preparation for a randomized controlled clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavioral: Cognitive Behavior Therapy | Other | Behavioral: Cognitive Behavioral Therapy |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 7 to 11
- Recently diagnosed with T1DM
- Treated at Mount Sinai or at North General Hospital
Key exclusion criteria (3 listed)
- Children below age 7 and above age 11
- Individual with diminished mental capacity, such that they would not be able to either complete the assessments or comprehend the materials presented in the intervention, will be excluded.
- Individuals without sufficient command of the English language to permit participation (due to the verbal nature of the intervention and the assessment package, and the linguistic limitations of the study team).
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 |
|---|---|---|
| Cognitive Behavioral TherapyThe treatment which incorporates cognitive restructuring and skill training, was designed to help children with diabetes and their families develop particular skills and optimistic/positive thinking style in order to facilitate better coping with the enduring demands and stress of diabetes management. The goal of the intervention was to improve the child's diabetes management both medically and psychologically by promoting optimism (positive outlook), mastery (problem-solving) and child-parent collaboration (team-work). | Behavioural | Behavioral: Cognitive Behavior Therapy |
Primary outcome
adherence
Time frame: at baseline
adherence
Time frame: at 3 months
adherence
Time frame: at 6 months
adherence
Time frame: at 9 months
quality of life
Time frame: at baseline
quality of life
Time frame: at 3 months
quality of life
Time frame: at 6 months
quality of life
Time frame: at 9 months
12 secondary outcomes
optimism
Time frame: at baseline
optimism
Time frame: at 3 months
optimism
Time frame: at 6 months
optimism
Time frame: at 9 months
self-efficacy
Time frame: at baseline
self-efficacy
Time frame: at 3 months
self-efficacy
Time frame: at 6 months
self-efficacy
Time frame: at 9 months
parent-child collaboration
Time frame: at baseline
parent-child collaboration
Time frame: at 3 months
parent-child collaboration
Time frame: at 6 months
parent-child collaboration
Time frame: at 9 months
Results and safety
The study was stopped early (reason given: decreased enrollment. (there are no data results for this study)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
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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.
Claude Chemtob, Ph.D. principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy in people with Type 1 Diabetes Mellitus, run by Icahn School of Medicine at Mount Sinai 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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 8 Jun 2011. 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 was stopped early (reason given: decreased enrollment. (there are no data results for this study)). Results are not available in the source record.
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?
adherence (time frame: at baseline). The study lists 8 primary outcomes in all. 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 8 Jun 2011.