NCT02714868

Brief Summary

The purpose of this study is to determine the extent to which Project TEAM (Teens making Environment and Activity Modifications) is an effective, socially valid, and feasible intervention that prepares youth with developmental disabilities ages 14-21 to respond to environmental barriers and increases participation in school, work, and the community. Project TEAM is a manualized intervention co- facilitated by a disability advocate and a licensed professional. The intervention includes eight group sessions and two experiential learning field trips. In addition, young adults with disabilities serve as peer mentors on field trips and contact youth weekly to support attainment of goals. Project TEAM outcomes are to: increase youths' knowledge of environmental factors and modification strategies; reduce the impact of environmental barriers on participation; increase self-efficacy and self-determination; and increase participation in a personal activity goal in the area of education, employment, or community life. This project builds on a participatory action research partnership with disability community stakeholders to address the following research questions: (1) To what extent do youth with disabilities participating in Project TEAM achieve intervention outcomes? (2) What are the characteristics of youth with disabilities who most benefit from Project TEAM? (3) To what extent are goals, procedures, and outcomes of Project TEAM important and acceptable (socially valid) to youth with disabilities?.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Status
completed

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

October 1, 2012

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 22, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2017

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

November 25, 2019

Completed
Last Updated

November 25, 2019

Status Verified

November 1, 2019

Enrollment Period

3.9 years

First QC Date

March 11, 2016

Results QC Date

July 27, 2017

Last Update Submit

November 21, 2019

Conditions

Keywords

repeated measuresmatched comparisonmanualized interventionself-determinationparticipationadvocacyproblem-solvingcommuinity participationoccupational therapyenvironment

Outcome Measures

Primary Outcomes (4)

  • Goal Attainment Scaling (GAS)

    All youth had four goals in the following areas: 1) a participation goal, 2) their ability to identify environmental barriers to their goal, 3) their ability to generate solutions to barriers, and 4) their ability to advocate for needed changes to achieve their goal. Each goal used a five-point goal attainment scale with baseline at -1. Goals levels were created at intake (initial assessment). For the knowledge application goals (goal 2-4), we created standardized goal levels to ensure content validity and reliability within and across youth. Goal attainment for all four goals was rated 12 weeks following intake (outcome) and transformed into a t-score. A t-score of 50 indicates all goals were achieved at the expected level; t-scores greater than 50 indicate individuals exceeded the expected level of goal attainment. Scores range from 0-100 (100 indicates greater than expected goal attainment).

    12 weeks following intake (outcome)

  • Project TEAM Knowledge Test

    Part I: Knowledge of parts of the environment, modification strategies, and the "Game Plan." Higher scores indicate more correct responses. Part I responses were independently coded as correct/incorrect by the study facilitator and a trained graduate student; discrepancies were resolved by a third scorer (the PI). To establish unidimensionality, we applied a dichotomous Rasch model and removed 24% of the items with Outfit Mean Square \>2; values higher than 2 can indicate guessing. The resulting interval sum scores, in logits, were used for analysis; higher logit scores indicate more knowledge (Minimum: -4.05 to maximum 6.69). Higher scores indicate greater problem solving.

    intake, 12 weeks following intake (outcome), 18 weeks following intake (6 week follow up)

  • AIR Self-Determination Scale (American Institutes on Research- AIR)

    The AIR measured the capacity and opportunity to act in a self-determined manner at home and school. Parallel youth and parent forms used a 5-point frequency scale (never-always), with higher scores reflecting more self-determination. Reported here are parent self-reported sum scores at outcome. Sum scores range from minimum 18- to maximum 90 (90/higher scores = more self determination)

    intake, 12 weeks following intake (outcome), 18 weeks following intake (6 week follow up)

  • Generalized Self Efficacy Scale (GSES)

    We revised a disability self-efficacy scale for this study and created additional questions to assess self-efficacy for addressing environmental barriers. We used a modified three point response scale (Not like me, Sort of like me, Really like me) that incorporated visuals to support comprehension. Higher scores indicated higher self-efficacy. Sum scores range from minimum 11 to maximum 33.

    intake, 12 weeks following intake (outcome), 18 weeks following intake (6 week follow up)

Secondary Outcomes (2)

  • Participation and Environment Measure for Children and Youth (PEM-CY)

    intake, 12 weeks following intake (outcome)

  • Readiness for Advocacy

    intake, 12 weeks following intake (outcome)

Study Arms (2)

Project TEAM Intervention

EXPERIMENTAL

Project TEAM is a manualized intervention co- facilitated by a disability advocate and a licensed professional. The intervention includes eight group sessions and two experiential learning field trips. In addition, young adults with disabilities serve as peer mentors on field trips and contact youth weekly to support attainment of goals. Project TEAM outcomes are to: increase youths' knowledge of environmental factors and modification strategies; reduce the impact of environmental barriers on participation; increase self-efficacy and self-determination; and increase participation in a personal activity goal in the area of education, employment, or community life.

Behavioral: Project TEAM

Matched comparison

ACTIVE COMPARATOR

Youth with disabilities who are matched controls will receive their typical educational or therapeutic services. Youth will receive a stipend to participate in a preferred activity in the community; youth will document what they did and with whom they participated. Attempts to control for the impact of resources on participation and goal achievement.

Behavioral: Matched Comparison

Interventions

Project TEAMBEHAVIORAL

Project TEAM is a manualized, group-based intervention designed to be co-facilitated by an experienced leader with a disability (disability advocate) and a licensed service provider (such as an occupational therapist, social worker, or educator). Project TEAM includes eight group sessions and two experiential learning field trips for each participant. Weekly phone calls with peer mentors with disabilities support achievement of each participant's personal activity goal.

Project TEAM Intervention

Participants set goal to try a new activity in the community

Matched comparison

Eligibility Criteria

Age14 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \) A developmental disability as defined by the Developmental Disabilities Assistance and Bill of Rights Act of 2000 (Public Law No.106-402) 9(example diagnoses include autism, intellectual disability, and cerebral palsy), 2) Age 14 to 21 years at time of enrollment, 3) Communicate in English verbally or using other means as needed, 4) Able to attend to a task for 10 minutes and follow a two-step direction with support, 5) Able to categorize objects and concepts, and 6) Self-identify as a youth with a disability as reported on a modified functional strengths and challenges questionnaire

You may not qualify if:

  • Learning disabilities without any other co-occuring diagnosis.
  • living outside of the university recruitment regions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Levin MR, Kramer JM. Key elements supporting goal attainment for transition-age young adults: A case illustration from Project TEAM. Inclusion 3: 145-161, 2015

    BACKGROUND
  • Kramer J, Hwang I, Helfrich C, Samuel P, Carralles A, YELL Youth Research Team. Evaluating the social validity of Project TEAM: A problem-solving intervention to teach transition age youth with developmental disabilities to resolve environmental barriers. International Journal of Disability, Development, & Education 65(1): 57-75, 2018

    RESULT
  • Schwartz AE, Kramer JM. "I just had to be flexible and show good patience": management of interactional approaches to enact mentoring roles by peer mentors with developmental disabilities. Disabil Rehabil. 2018 Oct;40(20):2364-2371. doi: 10.1080/09638288.2017.1334835. Epub 2017 Jun 8.

  • Kramer JM, Ryan CT, Moore R, Schwartz A. Feasibility of electronic peer mentoring for transition-age youth and young adults with intellectual and developmental disabilities: Project Teens making Environment and Activity Modifications. J Appl Res Intellect Disabil. 2018 Jan;31(1):e118-e129. doi: 10.1111/jar.12346. Epub 2017 Mar 1.

  • Ryan CT, Kramer JM, Cohn ES. Exploring the Self-Disclosure Process in Peer Mentoring Relationships for Transition-Age Youth With Developmental Disabilities. Intellect Dev Disabil. 2016 Aug;54(4):245-59. doi: 10.1352/1934-9556-54.4.245.

Related Links

MeSH Terms

Conditions

Developmental DisabilitiesCerebral PalsyAutistic DisorderIntellectual Disability

Interventions

Matched-Pair Analysis

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental DisordersBrain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAutism Spectrum DisorderChild Development Disorders, PervasiveNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesStatistics as TopicHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Limitations and Caveats

Missing responses to 1-3 items, we imputed a response using the median of responses to that item at that time period. We then obtained sum scores for each outcome measure (except GAS) for each participant.

Results Point of Contact

Title
Dr. Jessica Kramer, Assistant Professor, PI
Organization
Department of Occupational Therapy, Boston University

Study Officials

  • Jessica Kramer, PhD

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jessica Kramer, PhD, OTR/L, Director, Youth and Young Adult Empowerment, Leadership & Learning Lab

Study Record Dates

First Submitted

March 11, 2016

First Posted

March 22, 2016

Study Start

October 1, 2012

Primary Completion

September 1, 2016

Study Completion

July 31, 2017

Last Updated

November 25, 2019

Results First Posted

November 25, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

No data sharing is required under this grant