Clinical trial NCT02714868: Evaluation of Project TEAM (Teens Making Environmental and Activity Modifications)
Official title: Evaluation of Project TEAM (Teens Making Environmental and Activity Modifications) - Effectiveness, Social Validity and Feasibility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transition-age Youth
Developmental Disabilities
Cerebral Palsy
Autism
Intellectual Disability
Keywords: repeated measures
matched comparison
manualized intervention
self-determination
participation
advocacy
problem-solving
commuinity participation
occupational therapy
environment
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
Collaborators: name: Wayne State University
First posted: 2016-03-22
Enrollment: 82
Sex: ALL
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?.

Detailed description: Disparities in school, work, and community participation impact the 15% of youth in the United States estimated to have a developmental disability. A growing body of literature suggests disparities in participation are due to barriers in the physical and social environment. Practitioners and advocates have developed skill and advocacy interventions in an attempt to increase the participation of youth with disabilities. Yet none of these interventions focus specifically on acquiring the problem-solving skills needed to identify environmental barriers and generate modification strategies to resolve barriers to participation. Research indicates that there is a vital need to develop manualized, theory-based interventions that empower youth with developmental disabilities to identify and advocate for environments that support their participation in school, work, and the community.

The purpose of this study is to determine the extent to which Project TEAM 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. Pilot research showed that Project TEAM participants (N=20) had a significant increase in knowledge of environmental barriers and modification strategies (t(19) = -6.37, p=.00), and 57% increased their participation in one activity.

This project builds on a Participatory Action Research (PAR) 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? This project uses a multi-site, quasi-experimental repeated measures design with matched controls to evaluate Project TEAM. Sixty-four youth ages 14-21 with developmental disabilities will participate in Project TEAM and complete outcome measures at three time points: 2 weeks pre-intervention, 2 weeks post- intervention, and follow-up 6 weeks post-intervention. A control group of 64 youth, matched to intervention participant characteristics using a three tiered approach, will complete outcome measures at time points that correspond with the intervention group. Outcome measures assess goal attainment (Goal Attainment Scaling), knowledge and application of skills acquired during intervention (Project TEAM Knowledge Test), changes in participation and impact of barriers on participation (Participation and Environment Measure- Child \&Youth), self-efficacy (Generalized Self Efficacy Scale), and self-determination (AIR Self-Determination Scale). Characteristics that may influence the extent to which youth benefit from Project TEAM will be assessed using a battery of descriptive measures. Outcomes will be analyzed within and across groups to evaluate the effectiveness of Project TEAM. Feasibility and adherence to the proposed design will be evaluated using a process evaluation.

To evaluate social validity, a Youth Research Panel (YRP) of 6 youth with disabilities ages 14-21 and a Consumer Research Specialist will administer a satisfaction survey and focus group interview to Project TEAM participants. Parents (n= 64) will also participate in on-line focus groups to evaluate the feasibility and usefulness of Project TEAM. The YRP and other members of the research team will use an action/reflection process to interpret data and revise Project TEAM to maximize outcomes for future implementation. The YRP will disseminate information about Project TEAM to local and national capacity- building organizations targeted to youth with disabilities. The PI will also disseminate findings to professionals and the disability community via a website, presentations, and peer- reviewed journals.

Eligibility criteria: Inclusion Criteria:

* 1) 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

Exclusion Criteria:

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

Primary outcomes:
measure: Goal Attainment Scaling (GAS)
timeFrame: 12 weeks following intake (outcome)
measure: Project TEAM Knowledge Test
timeFrame: intake, 12 weeks following intake (outcome), 18 weeks following intake (6 week follow up)
measure: AIR Self-Determination Scale (American Institutes on Research- AIR)
timeFrame: intake, 12 weeks following intake (outcome), 18 weeks following intake (6 week follow up)
measure: Generalized Self Efficacy Scale (GSES)
timeFrame: intake, 12 weeks following intake (outcome), 18 weeks following intake (6 week follow up)
Secondary outcomes:
measure: Participation and Environment Measure for Children and Youth (PEM-CY)
timeFrame: intake, 12 weeks following intake (outcome)
measure: Readiness for Advocacy
timeFrame: intake, 12 weeks following intake (outcome)
Other outcomes:
Locations:
Study officials:
affiliation: Assistant Professor
name: Jessica Kramer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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
citation: 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.
citation: 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.
citation: 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.