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Building Better Bridges Randomized Control Trial ((AIR-B3))

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention Coaching Group
Sponsored by
Health Resources and Services Administration (HRSA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Transitions, Passport, Building Better Bridges, Snapshot

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children:

    • Transitioning into kindergarten or secondary school (middle/high school)
    • Parent-rated SCQ total score > 15 and AT LEAST one of the following:

      • Positive ADOS-2 administered by research-reliable study personnel
      • Expert medical diagnosis or educational classification of ASD
    • Under-resourced, defined by:

      • Attending or transitioning into a Title I school (a school that receives federal funding to improve the performance of economically disadvantaged students)or rural school
      • Family income is under 250% of the federal guidelines for poverty rate (i.e., meets federal requirements to qualify for free or reduced lunch)
    • Parent/Caregiver willing to participate

(Site PIs may request eligibility review by PIs across all AIR-B sites if a school is not Title I or rural but is demonstrably low-resource)

Adults:

  • Must be a parent/caregiver of a child who meets criteria above
  • Must be a provider/teacher/school administrator or other adult involved in either the pre-transition process or the post transition process for a participating child.

Exclusion Criteria:

  • Children:

    • Not transitioning into kindergarten or secondary school
    • No ASD diagnosis
    • Not meeting study criteria for classification as under-resourced
    • Parent/Caregiver unwilling to participate

Adults:

  • Not a parent/guardian of a child with ASD
  • Not part of a participating child with ASD's pre or post transition team

Sites / Locations

  • UC Davis
  • University of Rochester
  • UPENN

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Transition Passport Comparison Group

Intervention Coaching Group

Arm Description

This group will only receive the Transition Passport, which includes the Transition Checklist, Student Snapshot, Parent/Caregiver Guide, and Student Guide.

This group will also receive the Transition Passport, which includes the Transition Checklist, Student Snapshot, Parent/Caregiver Guide, and Student Guide. This group will also receive coaching support to implement these resources. The coach will be a member of the research team who will introduce the resources to the family, briefly teach them fundamental information about the transition process, provide brief coaching phone calls, and help parents identify an appropriate person at the school or district who can work with them to complete the Student Snapshot. This group will also use ParentSquare to enhance and encourage communication between parent and members of the child's school team.

Outcomes

Primary Outcome Measures

Transition Evaluation Questionnaire (TEQ)
This measure was created by the research team. We capture the parents and pre and post transition personnels thoughts on how the transition process is going for the child at the beginning of the study and throughout the big school transition. Communication and transition planning at home and school is also captured in this measure. It is rated from 0(not knowing anyone in the child's school) to 5 (very satisfied, very effective, high support) with the child's transition process. We expect to start around 1(not effective/no communication) or 2 (little effective/little successful) at the beginning of the study and end at a 4 (mostly successful/effective) or a 5(very satisfied/effective).
Transition Evaluation Questionnaire (TEQ)
This measure was created by the research team. We capture the parents and pre and post transition personnels thoughts on how the transition process is going for the child at the beginning of the study and throughout the big school transition. Communication and transition planning at home and school is also captured in this measure. It is rated from 0(not knowing anyone in the child's school) to 5 (very satisfied, very effective, high support) with the child's transition process. We expect to start around 1(not effective/no communication) or 2 (little effective/little successful) at the beginning of the study and end at a 4 (mostly successful/effective) or a 5(very satisfied/effective).
Transition Evaluation Questionnaire (TEQ)
This measure was created by the research team. We capture the parents and pre and post transition personnels thoughts on how the transition process is going for the child at the beginning of the study and throughout the big school transition. Communication and transition planning at home and school is also captured in this measure. It is rated from 0(not knowing anyone in the child's school) to 5 (very satisfied, very effective, high support) with the child's transition process. We expect to start around 1(not effective/no communication) or 2 (little effective/little successful) at the beginning of the study and end at a 4 (mostly successful/effective) or a 5(very satisfied/effective).
Transition Evaluation Questionnaire (TEQ)
This measure was created by the research team. We capture the parents and pre and post transition personnels thoughts on how the transition process is going for the child at the beginning of the study and throughout the big school transition. Communication and transition planning at home and school is also captured in this measure. It is rated from 0(not knowing anyone in the child's school) to 5 (very satisfied, very effective, high support) with the child's transition process. We expect to start around 1(not effective/no communication) or 2 (little effective/little successful) at the beginning of the study and end at a 4 (mostly successful/effective) or a 5(very satisfied/effective).

Secondary Outcome Measures

Engagement vs.Disaffection
This measure will provide information on the change of each child's behavior throughout the transition process. It will be measure through the parents and school personnels perspectives. Filled out by parents and school personnel.
Social Dynamics of Intervention_ASD (Autism Spectrum Disorder)- SoDI
This measure shows the level of support and how well connected parents and school personnel of the children in the study are in their community and in their child's school setting. Filled out by parents and school personnel.
Parent Engagement (ESE)
This measure will demonstrate each parent's knowledge and engagement in their child's transition process.
Community Capital
This survey measures how each parent's community involvement/importance influences their behavior.
Usability & Acceptability Form
Measures how useful each tool and component of the intervention was for parents and school personnel.
Strategies Survey
Description of strategies that help the child with the transition process and schooling in general.
Transition Practices
Measures each school personnel's level of engagement that helps with the transition process, such as what tools, activities, and strategies they used to help the child.
Burnout Measure
Measures each school personnel's burnout level at entry.
School Situations Questionnaire (SSQ)
Describes child's behavior in different school situations and the severity of the behavior.

Full Information

First Posted
January 15, 2018
Last Updated
February 8, 2022
Sponsor
Health Resources and Services Administration (HRSA)
Collaborators
University of Rochester, University of Pennsylvania, University of California, Davis, Drexel University
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1. Study Identification

Unique Protocol Identification Number
NCT03445520
Brief Title
Building Better Bridges Randomized Control Trial
Acronym
(AIR-B3)
Official Title
Building Better Bridges School Transitions RCT
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 15, 2018 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Health Resources and Services Administration (HRSA)
Collaborators
University of Rochester, University of Pennsylvania, University of California, Davis, Drexel University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In this study, the investigators will randomize 20 families per site (across 4 sites) to be in the BBB Transition Passport Only Group or BBB Intervention Group. Both groups will receive the BBB Transition Passport, which include the Transition Checklist, Student Snapshot, Parent/Caregiver Guide, and Student Guide. In addition to receiving the Transition Passport, the BBB Intervention Group will also receive coaching support to implement these resources. This coaching will include a member of the research team assigned as a coach for each family. This coach will introduce the resources to the family, briefly teach them fundamental information about the transition process, provide brief coaching phone calls, and guide parents in using the tools and requesting help from the child's provider(s). The investigators will be testing the differences between these two groups in terms of: 1) quality of the transition as reported by the parent and teacher, 2) self-efficacy of the parent during the transition process, 3) child school engagement and behavior during the transition as rated by the teacher and parent, and 4) the quality of the child's team to communicate about information important to the child's transition.
Detailed Description
Building Better Bridges (BBB), will evaluate an intervention designed to support the needs of students with autism who are transitioning from either preschool to elementary school, or from elementary to secondary school. In this randomized controlled trial, the investigators will randomly assign a total of 160 families (40 families/site, across 4 sites, over 2 years) to one of two intervention groups: BBB Transition Passport Only Group (Comparison) or BBB Intervention Group. Both groups will receive the BBB Transition Passport, which include the Transition Checklist, Student Snapshot, Parent/Caregiver Guide, and Student Guide. In addition to receiving the Transition Passport, the BBB Intervention Group will also receive coaching support to implement these resources. The coach will be a member of the research team who will introduce the resources to the family, briefly teach them fundamental information about the transition process, provide brief coaching phone calls, and help parents identify an appropriate person at the school or district who can work with them to complete the Student Snapshot. The research staff will first recruit interested schools, and school administrators will identify potential teachers who may have eligible students. If the teacher agrees to participate, he/she will send the study flyer home to parents where parents can either call the study phone line to learn more, or can fill out the study interest portion of the flyer and turn it in to their teachers. Parents who fill out the interest sheet will be contacted by the research staff. Interested parents can also contact research staff. All parents will receive a screening over the telephone to determine eligibility, which will include an Social Communication Questionnaire (SCQ) over the phone and will ask if their child has received a diagnosis of Autism by the administration of an Autism Diagnostic Observation Schedule (ADOS) or any other official diagnosis. The investigators will accept an ADOS diagnosis within one year for children in preschool and within three years for students transitioning to secondary school.. If an ADOS or any record of an official diagnosis is not provided, the research staff will schedule a time to administer the ADOS to determine eligibility. We will also ask if the child has a record of a cognitive test like the Stanford Binet-5. If parents do not have a record or if it has been over a year since the pre-school child or over 3 years since the older child has had one, the research staff will also schedule with the parents to administer it around the same time as the ADOS. After the initial phone screen and verification of autism diagnosis, the parent will be consented and then will complete baseline T1 measures. Pre-transition teachers will complete T1 measures as well. Schedule of measures can be found in the Outcome Measures Section. Following enrollment into the study, the child will be randomized to one of two treatment groups, BBB Comparison Group(Control) or BBB Intervention Group. Families randomized to the control group will only have access to the BBB Transition Passport, which consists of the Transition Checklist, Parent Guide, Student Guide, and the Student Snapshot. A hard copy of these tools will be given to them. We will also provide them with a link to download them online through LiveBinder (online website). Families randomized to the BBB Intervention group will be enrolled in ParentSquare if they agreed to it in the consent form. ParentSquare is an app that provides a safe and secure platform for program-to-parent communication. ParentSquare is in compliance with Family Educational Rights and Privacy Act (FERPA). Any school team members who want to use ParentSquare will be consented to use it and agree to allow the de-identified data from ParentSquare to be used for research purposes. The participants in this group will also have access to download the tools and share them with each other. Parents in the intervention group will also receive six, 1 hour, coaching sessions (one session per month for six months), with a research staff coach, to discuss key information about transitions (knowing parent's rights about special education services, communicating effectively with school staff, knowing the roles of the school team members, preparing their child over the summer, developing and sharing their Snapshot). These coaching sessions will occur individually (in-person or by telephone) during the pre-transition school year. In addition, parents will receive ongoing 1-2 monthly follow up phone calls (10 minutes each) to see how the transition planning is going, to help the parent problem-solve around any concerns about the transition, and to encourage the parent to implement all components of the intervention (including conducting at least one school visit, working on the student guide, and completing the Student Snapshot with the school team). These coaching calls are expected to start in February during the pre-transition school year and continue through November of the post-transition year. Coaching calls are designed to be flexible and brief and can occur in person or by telephone, or by a secure internet-based platform (Zoom), depending on the parent's preference. The coach will encourage the parent to identify a school staff member to help with preparing for the transition. This person can be the child's teacher, provider, or someone else from the school or district who can assist with the child's transition. The coach will encourage the parent to work with this school person to arrange a meeting prior to the transition (or join an existing meeting), for the purpose of completing the Student Snapshot and meeting with a post-transition teacher or staff from the receiving school, if possible. This school staff person can also help to recruit other school team members working on the transition process and to utilize Parent Square for all communication and sharing of transition materials. Any team member involved in the transition will be offered to be consented and given access to Parent Square. This meeting will occur at a time convenient for the school team, likely in April or May. If the post-transition school personnel can attend the meeting (if known prior to the transition), they will also be consented for the study form. During this meeting, everyone will work together to complete the BBB Passport materials. If the post transition school team is not able to participate in a pre-transition meeting, then the coach will encourage the parent to share the Student Snapshot with the post-transition teacher(s) and school team when the new school year begins in the Fall.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Transitions, Passport, Building Better Bridges, Snapshot

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
375 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transition Passport Comparison Group
Arm Type
No Intervention
Arm Description
This group will only receive the Transition Passport, which includes the Transition Checklist, Student Snapshot, Parent/Caregiver Guide, and Student Guide.
Arm Title
Intervention Coaching Group
Arm Type
Experimental
Arm Description
This group will also receive the Transition Passport, which includes the Transition Checklist, Student Snapshot, Parent/Caregiver Guide, and Student Guide. This group will also receive coaching support to implement these resources. The coach will be a member of the research team who will introduce the resources to the family, briefly teach them fundamental information about the transition process, provide brief coaching phone calls, and help parents identify an appropriate person at the school or district who can work with them to complete the Student Snapshot. This group will also use ParentSquare to enhance and encourage communication between parent and members of the child's school team.
Intervention Type
Behavioral
Intervention Name(s)
Intervention Coaching Group
Intervention Description
Parents in this group receive six, 1 hour, coaching sessions with a research staff coach, to discuss key information about transitions (knowing parent's rights about special education services, communicating effectively with school staff, knowing the roles of the school team members, how to develop and share your Snapshot, and what to do with your child over the summer to help with the transition). The coach will encourage the parent to identify a school staff member to help with preparing for the transition. If the post transition school team is not able to participate in a pre-transition meeting, then the coach will encourage the parent to share the Student Snapshot with the post-transition teacher(s) and school team when the new school year begins in the Fall.
Primary Outcome Measure Information:
Title
Transition Evaluation Questionnaire (TEQ)
Description
This measure was created by the research team. We capture the parents and pre and post transition personnels thoughts on how the transition process is going for the child at the beginning of the study and throughout the big school transition. Communication and transition planning at home and school is also captured in this measure. It is rated from 0(not knowing anyone in the child's school) to 5 (very satisfied, very effective, high support) with the child's transition process. We expect to start around 1(not effective/no communication) or 2 (little effective/little successful) at the beginning of the study and end at a 4 (mostly successful/effective) or a 5(very satisfied/effective).
Time Frame
entry (1st month of the study)
Title
Transition Evaluation Questionnaire (TEQ)
Description
This measure was created by the research team. We capture the parents and pre and post transition personnels thoughts on how the transition process is going for the child at the beginning of the study and throughout the big school transition. Communication and transition planning at home and school is also captured in this measure. It is rated from 0(not knowing anyone in the child's school) to 5 (very satisfied, very effective, high support) with the child's transition process. We expect to start around 1(not effective/no communication) or 2 (little effective/little successful) at the beginning of the study and end at a 4 (mostly successful/effective) or a 5(very satisfied/effective).
Time Frame
end of school year (4th month of the study)
Title
Transition Evaluation Questionnaire (TEQ)
Description
This measure was created by the research team. We capture the parents and pre and post transition personnels thoughts on how the transition process is going for the child at the beginning of the study and throughout the big school transition. Communication and transition planning at home and school is also captured in this measure. It is rated from 0(not knowing anyone in the child's school) to 5 (very satisfied, very effective, high support) with the child's transition process. We expect to start around 1(not effective/no communication) or 2 (little effective/little successful) at the beginning of the study and end at a 4 (mostly successful/effective) or a 5(very satisfied/effective).
Time Frame
6 weeks post new school year (7th month of the study)
Title
Transition Evaluation Questionnaire (TEQ)
Description
This measure was created by the research team. We capture the parents and pre and post transition personnels thoughts on how the transition process is going for the child at the beginning of the study and throughout the big school transition. Communication and transition planning at home and school is also captured in this measure. It is rated from 0(not knowing anyone in the child's school) to 5 (very satisfied, very effective, high support) with the child's transition process. We expect to start around 1(not effective/no communication) or 2 (little effective/little successful) at the beginning of the study and end at a 4 (mostly successful/effective) or a 5(very satisfied/effective).
Time Frame
3 months post new school year (10th month of the study)
Secondary Outcome Measure Information:
Title
Engagement vs.Disaffection
Description
This measure will provide information on the change of each child's behavior throughout the transition process. It will be measure through the parents and school personnels perspectives. Filled out by parents and school personnel.
Time Frame
entry (1st month of the study), end of school year (4th month of the study), 6 weeks post new school year (7th month of the study), and 3 months post new school year (10th month of the study)
Title
Social Dynamics of Intervention_ASD (Autism Spectrum Disorder)- SoDI
Description
This measure shows the level of support and how well connected parents and school personnel of the children in the study are in their community and in their child's school setting. Filled out by parents and school personnel.
Time Frame
entry (1st month of the study), end of school year (4th month of the study), 6 weeks post new school year (7th month of the study), and 3 months post new school year (10th month of the study)
Title
Parent Engagement (ESE)
Description
This measure will demonstrate each parent's knowledge and engagement in their child's transition process.
Time Frame
entry (1st month of the study), end of school year (4th month of the study), 6 weeks post new school year (7th month of the study), and 3 months post new school year (10th month of the study)
Title
Community Capital
Description
This survey measures how each parent's community involvement/importance influences their behavior.
Time Frame
entry and 3 months post transition (10th month of the study)
Title
Usability & Acceptability Form
Description
Measures how useful each tool and component of the intervention was for parents and school personnel.
Time Frame
Parents: end of school year (4th month of the study), 6 weeks post-transition (7th month of the study), 3 months post-transition(10th month of the study) Pre-transition personnel: 4th month of study Post transition personnel: 10th month of study
Title
Strategies Survey
Description
Description of strategies that help the child with the transition process and schooling in general.
Time Frame
Parents: end of school year (4th month of study), 6 weeks post-transition(7th month of study) Pre-transition personnel: entry and end of school year (4th month of study) Post-transition personnel: 7th month of study, 10th month of study
Title
Transition Practices
Description
Measures each school personnel's level of engagement that helps with the transition process, such as what tools, activities, and strategies they used to help the child.
Time Frame
Pre-transition personnel: at entry Post-transition personnel: 6 weeks post-transition(7th month of the study)
Title
Burnout Measure
Description
Measures each school personnel's burnout level at entry.
Time Frame
Pre-transition personnel: entry Post-transition personnel: 6 weeks post-transition(7th month of study)
Title
School Situations Questionnaire (SSQ)
Description
Describes child's behavior in different school situations and the severity of the behavior.
Time Frame
Pre-transition personnel: entry, end of school year (4th month of study) Post-transition personnel: 6 weeks post-transition (7th month of study) and 3 months post-transition(10th month of study)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children: Transitioning into kindergarten or secondary school (middle/high school) Parent-rated SCQ total score > 15 and AT LEAST one of the following: Positive ADOS-2 administered by research-reliable study personnel Expert medical diagnosis or educational classification of ASD Under-resourced, defined by: Attending or transitioning into a Title I school (a school that receives federal funding to improve the performance of economically disadvantaged students)or rural school Family income is under 250% of the federal guidelines for poverty rate (i.e., meets federal requirements to qualify for free or reduced lunch) Parent/Caregiver willing to participate (Site PIs may request eligibility review by PIs across all AIR-B sites if a school is not Title I or rural but is demonstrably low-resource) Adults: Must be a parent/caregiver of a child who meets criteria above Must be a provider/teacher/school administrator or other adult involved in either the pre-transition process or the post transition process for a participating child. Exclusion Criteria: Children: Not transitioning into kindergarten or secondary school No ASD diagnosis Not meeting study criteria for classification as under-resourced Parent/Caregiver unwilling to participate Adults: Not a parent/guardian of a child with ASD Not part of a participating child with ASD's pre or post transition team
Facility Information:
Facility Name
UC Davis
City
Davis
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
UPENN
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-2648
Country
United States

12. IPD Sharing Statement

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Building Better Bridges Randomized Control Trial

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