NCT00439985

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 26, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

June 8, 2011

Status Verified

June 1, 2011

Enrollment Period

2.8 years

First QC Date

February 23, 2007

Last Update Submit

June 6, 2011

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 Diabetes Mellitus (T1DM)Metabolic ControlAdherenceOptimismParent-Child CollaborationPrevention

Outcome Measures

Primary Outcomes (8)

  • adherence

    at baseline

  • adherence

    at 3 months

  • adherence

    at 6 months

  • adherence

    at 9 months

  • quality of life

    at baseline

  • quality of life

    at 3 months

  • quality of life

    at 6 months

  • quality of life

    at 9 months

Secondary Outcomes (12)

  • optimism

    at baseline

  • optimism

    at 3 months

  • optimism

    at 6 months

  • optimism

    at 9 months

  • self-efficacy

    at baseline

  • +7 more secondary outcomes

Study Arms (1)

Behavioral: Cognitive Behavior Therapy

OTHER
Behavioral: Cognitive Behavioral Therapy

Interventions

Cognitive Behavioral TherapyBEHAVIORAL

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).

Behavioral: Cognitive Behavior Therapy

Eligibility Criteria

Age7 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 7 to 11
  • Recently diagnosed with T1DM
  • Treated at Mount Sinai or at North General Hospital

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029-6574, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Claude Chemtob, Ph.D.

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 23, 2007

First Posted

February 26, 2007

Study Start

September 1, 2006

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

June 8, 2011

Record last verified: 2011-06

Locations

US(1)