Type 1 DiabetesPhase 3STEPNCT00480493

STEP: Social Support To Empower Parents

A Phase 3 study testing STEP in people with Type 1 Diabetes, run by University of Massachusetts, Worcester at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 1 Diabetes
What is being tested?: STEP
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: Jun 2004to May 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Mothers and fathers of children 12 years and younger with type 1 diabetes

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Massachusetts, Worcester
Worcester, Massachusetts, 01655

Other trials in United States

About this study

This RCT intervention provides parental social support (informational, affirmational, and emotional) using parent mentors (experienced in the management of the chronic illness) for mothers and fathers of young children newly diagnosed with type 1 diabetes. The parent mentors provide both home visits and phone call support over the course of the first year after diagnosis. The hypothesis is that newly diagnosed parents who receive the intervention will perceive less parental concern and worry, less negative impact on the family, more perceived confidence and social support compared to those mothers and fathers not receiving the intervention.

Conditions: Type 1 Diabetes
Being tested: STEP
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.

STEPBehavioural
Also called Experimental arm: receives parent mentor support, Control arm: receives phone number of parent contact
Experimental: Minutes of parent mentor-parent participant interactions Control: Minutes of parent contact-parent participant interactions

Study groups in NCT00480493
Study group	Role	What they receive
Parent mentor contact	Experimental	Parent mentor provides face-to-face social support Receives: Behavioral: STEP
Control Arm	Active comparator	Parent is given a phone contact Receives: Behavioral: STEP

What is being measured

The primary outcome is the main question the study is designed to answer.

Maternal Confidence Scale
Maternal confidence in managing child with type 1 diabetes . Higher total scores (10 questions, minimum score of 0, maximum score of 50) mean a better outcome (greater maternal confidence)
Measured: 12 months
Parent Concern
Parent concern in managing child with type 1 diabetes. Higher total scores (58 questions, minimum score is 58; maximum score is 255) means more worry with managing child's diabetes care.
Measured: 12 months
Worry
Parent worry in managing child's care. Higher total scores (11 questions, minimum score is 11, maximum score is 44) indicate more parental worry
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2004May 2008

First posted31 May 2007 (estimated)
Study startJun 2004
Primary completionMay 2008
Study completionMay 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
More trials run by University of Massachusetts, WorcesterThe 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 3
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00480493
Sponsor's protocol ID: 1R15NR008391-01
Acronym: STEP
Status last verified: Jun 2012
First submitted: 29 May 2007
Last updated: 30 Jul 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 1 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: STEP: Social Support To Empower Parents
ClinicalTrials.gov ID: NCT00480493
Acronym / sponsor ID: STEP / 1R15NR008391-01
Conditions: Type 1 Diabetes
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: University of Massachusetts, WorcesterUniversity, hospital or other
Study start: Jun 2004
Primary completion: May 2008 (actual)
Study completion: May 2008 (actual)
First posted: 31 May 2007 (estimated)
Results: Posted 30 Jul 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Parent mentor contact	Experimental	Behavioral: STEPParent mentor provides face-to-face social support
Control Arm	Active comparator	Behavioral: STEPParent is given a phone contact

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Mothers and fathers of children 12 years and younger with type 1 diabetes

Key exclusion criteria (0 listed)

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
STEPAlso: Experimental arm: receives parent mentor support, Control arm: receives phone number of parent contactExperimental: Minutes of parent mentor-parent participant interactions Control: Minutes of parent contact-parent participant interactions	Behavioural	Control Arm, Parent mentor contact

Primary outcome

Maternal Confidence Scale
Time frame: 12 months
Maternal confidence in managing child with type 1 diabetes . Higher total scores (10 questions, minimum score of 0, maximum score of 50) mean a better outcome (greater maternal confidence)
Parent Concern
Time frame: 12 months
Parent concern in managing child with type 1 diabetes. Higher total scores (58 questions, minimum score is 58; maximum score is 255) means more worry with managing child's diabetes care.
Worry
Time frame: 12 months
Parent worry in managing child's care. Higher total scores (11 questions, minimum score is 11, maximum score is 44) indicate more parental worry

Results and safety

Results posted to the registry on 30 Jul 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Parent Mentor Contact	32	30
Control Arm	28	21

Primary outcome: Maternal Confidence Scale

Time frame: 12 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Parent Contact Control Arm n = 28	Parent Mentor Experimental Arm n = 32
Value	38 (7)	37 (10)

Parent Contact Control Arm vs Parent Mentor Experimental Arm: Mean Difference (Final Values): 2.46 (95% CI -4.32 to 9.24), p = 0.468, t-test, 2 sided

Population analysed: All participants with data were analyzed

Primary outcome: Parent Concern

Time frame: 12 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Parent Contact Control Arm n = 28	Parent Mentor Experimental Arm n = 32
Value	149 (38)	154 (45)

Parent Contact Control Arm vs Parent Mentor Experimental Arm: Mean Difference (Final Values): 4.82 (95% CI -15.47 to 25.11), p = 0.634, t-test, 2 sided

Primary outcome: Worry

Time frame: 12 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Parent Contact Control Arm n = 28	Parent Mentor Experimental Arm n = 32
Value	27 (7)	27 (7.5)

Parent Contact Control Arm vs Parent Mentor Experimental Arm: Mean Difference (Final Values): -2.48 (95% CI -8.76 to 3.80), p = 0.430, t-test, 2 sided

Adverse events

Time frame: Adverse event data tracked for entire study (3 years).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Parent Mentor Contact	0 of 32 (0%)	0 of 32 (0%)	Not reported
Control Arm	0 of 28 (0%)	0 of 28 (0%)	Not reported

Limitations and caveats (from the sponsor): We did not have enough parents recruited to look at structural equation modeling.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Obesity, Overweight
RecruitingPhase 1
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Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
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RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
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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.

Susan Sullivan-Bolyai, DNSc CNS RN principal investigator

University of Massachusetts, Worcester, Graduate School of Nurisng

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing STEP in people with Type 1 Diabetes, run by University of Massachusetts, Worcester 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 1 inclusion and 0 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 30 Jul 2012. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Maternal Confidence Scale (time frame: 12 months). 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 NCT00480493.

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 30 Jul 2012.