Type 1 DiabetesSTANDNCT01030471
Supporting Treatment Adherence Needs in Diabetes
A study testing Family-based cognitive-behavioral treatment in people with Type 1 Diabetes, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
There is an unmet treatment need for depressed adolescents with type 1 diabetes. To address this unmet need, we have designed a new, family-based, cognitive-behavioral intervention to reduce depressive symptoms, improve family functioning, and improve medication compliance. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Family-based cognitive-behavioral treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Sep 2012
- 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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 13-17
- Diagnosis of type 1 diabetes according to criteria from the ADA for at least 1 year
- Daily insulin dosing of at least 0.5 units per kilogram per day
- Clinical elevation on the CDI (i.e., score at or above 13)
- Assent to participation in study
Who cannot join
- Other chronic, physical disease or condition except for celiac or thyroid disease
- Diagnosis of major mental disorder (e.g., bipolar disorder, thought disorder, anorexia nervosa)
- Diagnosis of developmental disorder (e.g., mental retardation, autism, Asperger's)
- Current enrollment in psychotherapy specifically targeting depression
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Supporting Treatment Adherence Needs in Diabetes: The STAND Study
There is an unmet treatment need for depressed adolescents with type 1 diabetes. To address this unmet need, we have designed a new, family-based, cognitive-behavioral intervention to reduce depressive symptoms, improve family functioning, and improve medication compliance. The intervention is delivered in two phases (1 - reduction of depressive symptoms and family conflict, 2 - adherence promotion) as efforts to improve adherence will have a greater likelihood of success if individual and family functioning variables are addressed first. To test the effectiveness of this intervention in reducing depressive symptoms and improving adherence, we will conduct a randomized controlled trial comparing this new intervention to usual care in a sample of fifty-two adolescents with type 1 diabetes and their primary caregivers. Given the absence of this type of intervention and the significance of the problem, this study is timely and important, as it has the potential to positively impact diabetes-specific health outcomes.
- Conditions
- Type 1 Diabetes
- Being tested
- Family-based cognitive-behavioral treatment
- Keywords
- adolescents, depression, adherence, family functioning, intervention
- Medical subject headings
- Diabetes Mellitus, Type 1, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-based cognitive-behavioral treatmentBehavioural
Participants will engage in ten weekly sessions aimed at improving depressive symptoms and medication compliance via reducing family conflict and improving communication among family members.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Experimental | Not described Receives: Behavioral: Family-based cognitive-behavioral treatment |
| Wait list control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Depression Inventory (CDI)-Measure of adolescent depressive symptoms
Measured: Assessed at 0, 1.5, 3, and 6 months after enrollment
Diabetes-Related Family Conflict Scale (DFCS)-Measure of family conflict around diabetes-specific tasks
Measured: Assessed at 0, 1.5, 3, and 6 months from enrollment
Secondary outcomes (1)
Hemoglobin A1c value
Measured: Obtained at 0, 3, and 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2012
- Study completionSep 2012
Why it stopped: poor accrual
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.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Korey K Hood, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01030471
- Sponsor's protocol ID
- DK81711
- Other IDs
- R03DK081711
- Acronym
- STAND
- Status last verified
- Jun 2011
- First submitted
- 10 Dec 2009
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Treatment Adherence Needs in Diabetes: The STAND Study
- ClinicalTrials.gov ID
- NCT01030471
- Acronym / sponsor ID
- STAND / DK81711
- Conditions
- Type 1 Diabetes
- Keywords
- adolescents, depression, adherence, family functioning, intervention
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: poor accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2009 (actual)
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 11 Dec 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.
There is an unmet treatment need for depressed adolescents with type 1 diabetes. To address this unmet need, we have designed a new, family-based, cognitive-behavioral intervention to reduce depressive symptoms, improve family functioning, and improve medication compliance. The intervention is delivered in two phases (1 - reduction of depressive symptoms and family conflict, 2 - adherence promotion) as efforts to improve adherence will have a greater likelihood of success if individual and family functioning variables are addressed first. To test the effectiveness of this intervention in reducing depressive symptoms and improving adherence, we will conduct a randomized controlled trial comparing this new intervention to usual care in a sample of fifty-two adolescents with type 1 diabetes and their primary caregivers. Given the absence of this type of intervention and the significance of the problem, this study is timely and important, as it has the potential to positively impact diabetes-specific health outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Experimental | Behavioral: Family-based cognitive-behavioral treatment |
| Wait list control group | No intervention | – |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 13-17
- Diagnosis of type 1 diabetes according to criteria from the ADA for at least 1 year
- Daily insulin dosing of at least 0.5 units per kilogram per day
- Clinical elevation on the CDI (i.e., score at or above 13)
- Assent to participation in study
Key exclusion criteria (4 listed)
- Other chronic, physical disease or condition except for celiac or thyroid disease
- Diagnosis of major mental disorder (e.g., bipolar disorder, thought disorder, anorexia nervosa)
- Diagnosis of developmental disorder (e.g., mental retardation, autism, Asperger's)
- Current enrollment in psychotherapy specifically targeting depression
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 |
|---|---|---|
| Family-based cognitive-behavioral treatmentParticipants will engage in ten weekly sessions aimed at improving depressive symptoms and medication compliance via reducing family conflict and improving communication among family members. | Behavioural | Lifestyle counseling |
Primary outcome
Children's Depression Inventory (CDI)-Measure of adolescent depressive symptoms
Time frame: Assessed at 0, 1.5, 3, and 6 months after enrollment
Diabetes-Related Family Conflict Scale (DFCS)-Measure of family conflict around diabetes-specific tasks
Time frame: Assessed at 0, 1.5, 3, and 6 months from enrollment
1 secondary outcome
Hemoglobin A1c value
Time frame: Obtained at 0, 3, and 6 months after enrollment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
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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.
Korey K Hood, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family-based cognitive-behavioral treatment in people with Type 1 Diabetes, run by Children's Hospital Medical Center, Cincinnati 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 5 inclusion and 4 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: withdrawn, as of the sponsor's last update on 14 Sep 2020. 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 withdrawn before enrolling participants, so there are no results.
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?
Children's Depression Inventory (CDI)-Measure of adolescent depressive symptoms (time frame: Assessed at 0, 1.5, 3, and 6 months after enrollment). 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?
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 Sep 2020.