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临床试验/NCT03445520
NCT03445520已完成不适用

Building Better Bridges School Transitions RCT

Health Resources and Services Administration (HRSA)6 个研究点 分布在 1 个国家目标入组 375 人开始时间: 2018年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
375
试验地点
6
主要终点
Transition Evaluation Questionnaire (TEQ)

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 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)
  • 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.

排除标准

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

结局指标

主要结局

Transition Evaluation Questionnaire (TEQ)

时间窗: 3 months post new school year (10th month of the study)

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).

次要结局

  • Transition Practices(Pre-transition personnel: at entry Post-transition personnel: 6 weeks post-transition(7th month of the study))
  • School Situations Questionnaire (SSQ)(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))
  • Burnout Measure(Pre-transition personnel: entry Post-transition personnel: 6 weeks post-transition(7th month of study))
  • Engagement vs.Disaffection(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))
  • Social Dynamics of Intervention_ASD (Autism Spectrum Disorder)- SoDI(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))
  • Parent Engagement (ESE)(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))
  • Community Capital(entry and 3 months post transition (10th month of the study))
  • Usability & Acceptability Form(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)
  • Strategies Survey(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)

研究者

发起方
Health Resources and Services Administration (HRSA)
申办方类型
Fed
责任方
Principal Investigator
主要研究者

Connie Kasari, Ph.D.

Professor/PhD

Health Resources and Services Administration (HRSA)

研究点 (6)

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