NCT02663986

Brief Summary

The primary aim of this project is to address the need for an effective school-based intervention for elementary school-aged students with Organization, Time Management, and Planning (OTMP) deficits by adapting an evidence-supported clinic-based intervention so that it can be implemented in school settings. Investigators are learning to adapt an individual, clinic based program (OST-C) for children diagnosed with Attention Deficit Hyperactive Disorder (ADHD) to children with OTMP problems. Investigators will be collecting data . To this end, investigators will be collecting data on implementation (such as feasibility and acceptability), program development (what changes to the individual OST-C program were made based on findings during this study) and limited outcome data (repeated measures collection and pre- and post-treatment collection on a small sample, no control group).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 26, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2016

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

1.4 years

First QC Date

January 21, 2016

Last Update Submit

February 3, 2020

Conditions

Keywords

Organization, Time Management, and Planning (OTMP)

Outcome Measures

Primary Outcomes (8)

  • Change in scoring on Children's Organizational Skills Scale

    10 Weeks

  • Change in score on Organizational Skills Scale-Parent (COSS-P)

    10 Weeks

  • Change in score on Children's Organizational Skills Scale- (COSS-C)

    10 Weeks

  • Change in score on Organizational Skills Scale-Teacher (COSS-T) Versions COSS-P, COSS-C, and COSS-T

    be used to assess OTMP functioning at home and at school

    10 Weeks

  • Change in Homework Problem Checklist (HPCL) Score

    The HPCL (Anesko, Schoiock, Ramirez, \& Levine, 1987) was designed to assess various aspects of homework performance. Parents are requested to rate each of 20 homework problems on a scale from 0 = never a problem to 3 = very often a problem

    10 Weeks

  • Change in score on Academic Progress Report (APR)

    The APR (Abikoff et al, 2013) assesses proficiency in six academic subjects relative to standard expectations (1=Well below standard expected at this time of year; 3=At standard; 5=Well above standard). The sum of ratings across the six academic subjects is the unit of analysis. Reliability is acceptable (coefficient alpha = .84), and this measure is sensitive to OST treatment effects (Abikoff et al., 2013).

    10 Weeks

  • Change in score on Consumer Satisfaction Questionnaire (CSQ)

    To assess satisfaction with treatment, and to serve as an index of treatment credibility, a consumer satisfaction questionnaire adapted from McMahon and Forehand (2003), will be completed by parents and teachers at post-treatment. Items (rated 1-7) tap overall satisfaction with treatment, perceived improvement of the child on the problems of concern to parent or teacher respectively, and evaluation of treatment providers.

    10 Weeks

  • Measures of Feasibility

    Investigators will gather feasibility data based on completed activities during the study. They will record information about treatment training, number of groups run, number of students per group, scheduling challenges, number of meetings/contacts OST-S trainers had with teachers and parents, materials support, or any other items related to implementing the program will be recorded for the duration of the study.

    10 Weeks

Study Arms (1)

Organizational Skills Training (OST) Intervention

EXPERIMENTAL

To improve children's organizational functioning, OST focuses on four key skills. * Tracking Assignments * Managing Materials * Time Management * Task Planning

Behavioral: Organizational Skills Training (OST) Intervention

Interventions

Also known as: Organization, Time Management, and Planning (OTMP)
Organizational Skills Training (OST) Intervention

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children will be recruited based on their parents' interest level in having them participate in a program to improve their organizational skills.
  • Investigators will not use specific cutoffs on normed measures for determining eligibility based on these difficulties, as the intention is to develop a program that can be easily disseminated.
  • Availability to attend twice-weekly sessions with the OTMP trainer either during the school day (during a time when they would not be pulled from academic content) or during after-school hours.

You may not qualify if:

  • Children with Mental Retardation will not participate in the study, due to the difficulty they would likely have understanding the content of the sessions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

dolichyl-diphosphooligosaccharide - protein glycotransferaseMethodsOrganizationsTime Management

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Investigative TechniquesHealth Care Economics and OrganizationsPsychology, IndustrialPsychologyBehavioral SciencesBehavioral Disciplines and ActivitiesOrganization and AdministrationHealth Services Administration

Study Officials

  • Howard B Abikoff, MD

    New York University Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2016

First Posted

January 26, 2016

Study Start

February 1, 2015

Primary Completion

June 28, 2016

Study Completion

June 28, 2016

Last Updated

February 5, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations