Diabetes Mellitus, Type 1DI-CONCT02839031
Cognitive-Behavioral Therapy (CBT) in Children With Diabetes
A study testing "CBT" (Cognitive-Behavioral Therapy) in people with Diabetes Mellitus, Type 1, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Diabetes mellitus in children and adolescents is a source of stress and poor quality of life for themselves and their family. Development of adaptive coping strategies may be improved by focused parent and children training. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- "CBT" (Cognitive-Behavioral Therapy)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteFrance
- Study dates
- 11 Mar 2015to 1 Jul 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children and teenagers from 6 years-old to 18 years-old
- Having diabetes treated by insulin for at least 1 year
- Followed in pediatric diabetology department of Arnaud de Villeneuve Hospital in University Hospital of Montpellier
- Study Inform Consent signed by both children and parents
Who cannot join
- Children with developmental delay, severe mental disorders or language delay
- Non French-speaking family
- Children who does not live with at least one of his/her parents
- Children whose residence is not compatible with frequent visits at University Hospital of Montpellier
- Clinical status not compatible with study questionnaires assessment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of a Cognitive-behavioral Group Intervention in Children With Diabetes Mellitus and Their Parents
Diabetes mellitus in children and adolescents is a source of stress and poor quality of life for themselves and their family. Development of adaptive coping strategies may be improved by focused parent and children training. This study assesses a cognitive behavioral treatment (CBT) for children/adolescents with diabetes and their parents in comparison with standard health educational interventions. The investigators main aim is to verify that the CBT program improves overall balance of glycaemia better than phone contact without CBT content (control group). Secondary objectives are expected improvements of health-related quality of life and coping styles in parents and children.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- "CBT" (Cognitive-Behavioral Therapy), Control (telephonic support without CBT content)
- Keywords
- diabetes mellitus, glycaemia, cognitive-behavioral treatment, coping, parents, children
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"CBT" (Cognitive-Behavioral Therapy)Behavioural
Control (telephonic support without CBT content)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| "CBT" group | Experimental | Not described Receives: Behavioral: "CBT" (Cognitive-Behavioral Therapy) |
| Control group | Sham comparator | Not described Receives: Behavioral: Control (telephonic support without CBT content) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated hemoglobin (HbA1c) level
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study start11 Mar 2015
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Why it stopped: Recruitment difficulties (study stopped before the expected 80 inclusions)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839031
- Sponsor's protocol ID
- UF 9369
- Acronym
- DI-CO
- Status last verified
- Sep 2019
- First submitted
- 18 Jul 2016
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Cognitive-behavioral Group Intervention in Children With Diabetes Mellitus and Their Parents
- ClinicalTrials.gov ID
- NCT02839031
- Acronym / sponsor ID
- DI-CO / UF 9369
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- diabetes mellitus, glycaemia, cognitive-behavioral treatment, coping, parents, children
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties (study stopped before the expected 80 inclusions)
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 11 Mar 2015 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 20 Jul 2016 (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.
Diabetes mellitus in children and adolescents is a source of stress and poor quality of life for themselves and their family. Development of adaptive coping strategies may be improved by focused parent and children training. This study assesses a cognitive behavioral treatment (CBT) for children/adolescents with diabetes and their parents in comparison with standard health educational interventions. The investigators main aim is to verify that the CBT program improves overall balance of glycaemia better than phone contact without CBT content (control group). Secondary objectives are expected improvements of health-related quality of life and coping styles in parents and children.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "CBT" group | Experimental | Behavioral: "CBT" (Cognitive-Behavioral Therapy) |
| Control group | Sham comparator | Behavioral: Control (telephonic support without CBT content) |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Children and teenagers from 6 years-old to 18 years-old
- Having diabetes treated by insulin for at least 1 year
- Followed in pediatric diabetology department of Arnaud de Villeneuve Hospital in University Hospital of Montpellier
- Study Inform Consent signed by both children and parents
Key exclusion criteria (5 listed)
- Children with developmental delay, severe mental disorders or language delay
- Non French-speaking family
- Children who does not live with at least one of his/her parents
- Children whose residence is not compatible with frequent visits at University Hospital of Montpellier
- Clinical status not compatible with study questionnaires assessment.
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 |
|---|---|---|
| "CBT" (Cognitive-Behavioral Therapy) | Behavioural | "CBT" group |
| Control (telephonic support without CBT content) | Behavioural | Control group |
Primary outcome
Glycated hemoglobin (HbA1c) level
Time frame: up to 12 months
Results and safety
The study was stopped early (reason given: Recruitment difficulties (study stopped before the expected 80 inclusions)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "CBT" (Cognitive-Behavioral Therapy) in people with Diabetes Mellitus, Type 1, run by University Hospital, Montpellier at 1 site in France.
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 5 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 6 Sep 2019. 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 France. 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. Some participants in this study may receive a placebo. 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: Recruitment difficulties (study stopped before the expected 80 inclusions)). 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?
Glycated hemoglobin (HbA1c) level (time frame: up to 12 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 6 Sep 2019.