search
Back to results

Transitioning Together Boston

Primary Purpose

Autism or Autistic Traits, Family Relations

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transitioning Together (TT) / Juntos en la Transicion (JET)
Usual autism transition care
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism or Autistic Traits focused on measuring Multi-family group intervention sessions, Psychoeducational autism transition-to-adulthood, Problem-solving education, Quality of life of autistic youth, Goal attainment, Parent-youth dyad

Eligibility Criteria

14 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria for youth: Age 14 to 21 years old Be enrolled in high school or a specialized continued schooling program for youth ages 18 to 21. Has been seen at BMC at least once since 2015 Confirmation of the autism diagnosis Currently live at home with a parent/legal guardian A parent/legal guardian who meets the below criteria Inclusion Criteria for parents: Age at least 21 years old Parent/legal guardian of a youth who meets the youth criteria Parent/legal guardian is comfortable reading, writing, speaking, and listening in English and/or Spanish Exclusion Criteria: A primary home language for the family is not English or Spanish (the intervention and assessments are only available in English and Spanish) The autistic youth currently resides independently, in supported housing, or with a foster family or other Department of Children and Families (DCF) placement Either the youth or their parent/guardian chooses not to participate in the study (one cannot participate without the other)

Sites / Locations

  • Boston Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Transitioning Together

Usual Care

Arm Description

Participants in this arm will receive the Transitioning Together intervention in English or Spanish either at BMC, at BMC's Supporting Parents & Resilient Kids (SPARK) Center or on BMC Zoom.

Participants in this arm will receive a referral to usual transition-related care through the BMC Developmental and Behavioral Pediatrics (DBP) clinic/the BMC Autism Program.

Outcomes

Primary Outcome Measures

Change in quality of life of autistic youth
The Global Health, Emotional Distress, Subjective Well-Being, and Relationships sub scales of the NIH Patient-Reported Outcomes Measurement Information Systems (PROMIS) will be administered via parent proxy (and youth self-report when appropriate) to asses the quality of life for autistic youth. Item scores can range from 1 to 5 and higher scores are associated with a higher quality of life.
Change in transition-related goal attainment
The Goal Attainment Scaling will be administered to asses transition-related goal attainment. It is a valid and reliable technique to benchmark success in meeting individualized goals. Scores can range from 0 to 4 and higher scores are associated with better goal attainment.
Change in youth problem behaviors
The Scales of Independent Behavior-Revised Problem Behavior Scale will be administered to assess frequency and severity of problem behaviors in youth. It is a parent-report questionnaire. For problem behaviors that occurred, items scores can range from 1 to 5 for frequency and severity, with a higher score associated with higher frequency and higher severity of the problem behavior.

Secondary Outcome Measures

Change in family empowerment
The Family Empowerment Scale will be administered to asses family empowerment. It is a self-report scale that measures empowerment in families with children who have emotional or behavioral disorders and has robust psychometric properties. Item scores can range from 1 to 5 and higher scores are associated with more family empowerment.
Change in coping
The Brief Coping Orientation to Problems Experienced Inventory (COPE) will be administered to asses family coping skills. It is a self-report questionnaire that measures adaptive and maladaptive coping responses to adversity, validated in health-care settings. Item scores can range from 1 to 4 and higher/lower subscale scores are associated with a higher level of the coping style measured in that subscale.
Change in social support
The Medical Outcomes Study (MOS) Social Support Survey will be administered to asses social support. It is a self-report questionnaire that measures the availability of other people to provide social support through emotional, informational, tangible, affectionate, and social dimensions. Item scores can range from 1 to 5 and higher scores are associated with more social support.
Change in perceived burden
The Zarit Burden Interview will be administered to asses perceived burden related to taking care of another person. It is a self-report questionnaire. Item scores can range from 0 to 4 and higher scores are associated with more perceived burden.
Change in parental well-being
The Generalized Anxiety Screener and the Patient Health Questionnaire will be administered to asses parental well-being - specifically anxiety and depression symptoms. Both measures are self-report questionnaires. It is a self-report questionnaire. On the both measures, item scores range from 0 to 3 and higher scores are associated with higher severity of symptoms.
Change in family climate
The Five-Minute Speech Sample and the Happy Proud Scale will be administered to asses family climate. The Five Minute Speech Sample is a 5-minute sample of a caregiver speaking about their relationship with their child that is scored to measure caregivers' expressed emotion regarding a relative with a mental health condition. The Happy Proud Scale measures parent and youth feelings of pride and happiness with regard to the things the youth does. Item scores range from 0 to 4 with higher scores associated with higher feelings of pride and happiness.
Change in transition readiness
The Transition Readiness Scale will be used to assess youth readiness for the transition to adulthood. It is a parent proxy and youth self-report questionnaire. Item scores range from 1 to 4. Higher scores are associated with higher transition readiness. Additionally, the Waisman Activities of Daily Living Scale will be used to assess the level of independent aspect of transition readiness. It is a parent proxy report questionnaire. Item scores range from 0 to 2. Higher scores are associated with higher independence in performing tasks on one's own.

Full Information

First Posted
October 26, 2022
Last Updated
February 10, 2023
Sponsor
Boston Medical Center
Collaborators
Deborah Munroe Noonan Memorial Research Fund
search

1. Study Identification

Unique Protocol Identification Number
NCT05599711
Brief Title
Transitioning Together Boston
Official Title
Testing the Efficacy of an Adapted Family-Centered Autism Transition Intervention in a Safety Net Hospital Setting
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Medical Center
Collaborators
Deborah Munroe Noonan Memorial Research Fund

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
A randomized controlled trial will be conducted to determine the effects of an adapted family-centered autism transition intervention called Transitioning Together/Juntos en la Transición on meaningful outcomes for families. The study will occur in a safety net hospital setting. The adapted version of this multi-family group psychoeducation intervention is delivered across one individual family joining session and four 2.5 hour multi-family group sessions. The parent and youth groups are held in separately, at the same time.
Detailed Description
Objective 1: The investigators will test the efficacy of the adapted version of Transitioning Together on youth quality of life and progress toward individual transition goals. 128 English and/or Spanish speaking families of youth ages 14-21 years will be enrolled in the study. The primary enrollment site is Boston Medical Center (BMC), an urban safety net hospital where patients predominantly (>75%) from low-income households are served. The effects of Transitioning Together will be compared to a usual care control condition with a referral to the Transition Specialist within BMC's Developmental and Behavioral Pediatrics clinic. Youth quality of life and progress toward individual transition goals will be compared from baseline and three-to-six months following randomization. The investigators hypothesize that Transitioning Together will have a significant positive effect on youth quality of life and goal attainment across the two time points. Objective 2: Additional standardized assessments will be administered to the 128 parents and the 128 autistic youth, to examine the effects of Transitioning Together compared to the control condition on: the broader family unit's well-being, empowerment, coping skills, social support, transition readiness, and family climate. The investigators will explore whether these factors act to mediate or moderate primary or secondary study outcomes (youth quality of life and progress toward individual transition goals). These putative mediators and moderators will be assessed at the baseline and 3-to 6-months following randomization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism or Autistic Traits, Family Relations
Keywords
Multi-family group intervention sessions, Psychoeducational autism transition-to-adulthood, Problem-solving education, Quality of life of autistic youth, Goal attainment, Parent-youth dyad

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Transitioning Together
Arm Type
Experimental
Arm Description
Participants in this arm will receive the Transitioning Together intervention in English or Spanish either at BMC, at BMC's Supporting Parents & Resilient Kids (SPARK) Center or on BMC Zoom.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Participants in this arm will receive a referral to usual transition-related care through the BMC Developmental and Behavioral Pediatrics (DBP) clinic/the BMC Autism Program.
Intervention Type
Behavioral
Intervention Name(s)
Transitioning Together (TT) / Juntos en la Transicion (JET)
Intervention Description
One individual family joining session when each family dyad meets with group therapists to establish rapport and share their own unique family's background, goals, and supports. A series of four 2.5-hour multi-family group psychoeducation intervention sessions focused on problem-solving education and psychoeducational autism transition-to-adulthood content which can include independence in adulthood, community involvement, guardianship and legal issues, employment and education, health and well-being.
Intervention Type
Behavioral
Intervention Name(s)
Usual autism transition care
Intervention Description
An expedited referral will be made for participants to establish care with a BMC Autism Program Transition/Resource Specialist. Data will be abstracted from the electronic medical record on how many visits each family completes with a BMC Autism Program Transition/Resource Specialist or other BMC Developmental and Behavioral Pediatrics provider throughout the study period.
Primary Outcome Measure Information:
Title
Change in quality of life of autistic youth
Description
The Global Health, Emotional Distress, Subjective Well-Being, and Relationships sub scales of the NIH Patient-Reported Outcomes Measurement Information Systems (PROMIS) will be administered via parent proxy (and youth self-report when appropriate) to asses the quality of life for autistic youth. Item scores can range from 1 to 5 and higher scores are associated with a higher quality of life.
Time Frame
Baseline, 3-6 months
Title
Change in transition-related goal attainment
Description
The Goal Attainment Scaling will be administered to asses transition-related goal attainment. It is a valid and reliable technique to benchmark success in meeting individualized goals. Scores can range from 0 to 4 and higher scores are associated with better goal attainment.
Time Frame
Baseline, 3-6 months
Title
Change in youth problem behaviors
Description
The Scales of Independent Behavior-Revised Problem Behavior Scale will be administered to assess frequency and severity of problem behaviors in youth. It is a parent-report questionnaire. For problem behaviors that occurred, items scores can range from 1 to 5 for frequency and severity, with a higher score associated with higher frequency and higher severity of the problem behavior.
Time Frame
Baseline, 3-6 months
Secondary Outcome Measure Information:
Title
Change in family empowerment
Description
The Family Empowerment Scale will be administered to asses family empowerment. It is a self-report scale that measures empowerment in families with children who have emotional or behavioral disorders and has robust psychometric properties. Item scores can range from 1 to 5 and higher scores are associated with more family empowerment.
Time Frame
Baseline, 3-6 months
Title
Change in coping
Description
The Brief Coping Orientation to Problems Experienced Inventory (COPE) will be administered to asses family coping skills. It is a self-report questionnaire that measures adaptive and maladaptive coping responses to adversity, validated in health-care settings. Item scores can range from 1 to 4 and higher/lower subscale scores are associated with a higher level of the coping style measured in that subscale.
Time Frame
Baseline, 3-6 months
Title
Change in social support
Description
The Medical Outcomes Study (MOS) Social Support Survey will be administered to asses social support. It is a self-report questionnaire that measures the availability of other people to provide social support through emotional, informational, tangible, affectionate, and social dimensions. Item scores can range from 1 to 5 and higher scores are associated with more social support.
Time Frame
Baseline, 3-6 months
Title
Change in perceived burden
Description
The Zarit Burden Interview will be administered to asses perceived burden related to taking care of another person. It is a self-report questionnaire. Item scores can range from 0 to 4 and higher scores are associated with more perceived burden.
Time Frame
Baseline, 3-6 months
Title
Change in parental well-being
Description
The Generalized Anxiety Screener and the Patient Health Questionnaire will be administered to asses parental well-being - specifically anxiety and depression symptoms. Both measures are self-report questionnaires. It is a self-report questionnaire. On the both measures, item scores range from 0 to 3 and higher scores are associated with higher severity of symptoms.
Time Frame
Baseline, 3-6 months
Title
Change in family climate
Description
The Five-Minute Speech Sample and the Happy Proud Scale will be administered to asses family climate. The Five Minute Speech Sample is a 5-minute sample of a caregiver speaking about their relationship with their child that is scored to measure caregivers' expressed emotion regarding a relative with a mental health condition. The Happy Proud Scale measures parent and youth feelings of pride and happiness with regard to the things the youth does. Item scores range from 0 to 4 with higher scores associated with higher feelings of pride and happiness.
Time Frame
Baseline, 3-6 months
Title
Change in transition readiness
Description
The Transition Readiness Scale will be used to assess youth readiness for the transition to adulthood. It is a parent proxy and youth self-report questionnaire. Item scores range from 1 to 4. Higher scores are associated with higher transition readiness. Additionally, the Waisman Activities of Daily Living Scale will be used to assess the level of independent aspect of transition readiness. It is a parent proxy report questionnaire. Item scores range from 0 to 2. Higher scores are associated with higher independence in performing tasks on one's own.
Time Frame
Baseline, 3-6 months
Other Pre-specified Outcome Measures:
Title
Intervention acceptability, appropriateness, and feasibility
Description
The Acceptability of Intervention Measure, the Intervention Appropriateness Measure, and the Feasibility of Intervention measure will be used to assess perceptions of intervention acceptability, appropriateness, and feasibility among participants who received the Transitioning Together intervention. These are each brief self-report questionnaires. Item scores range from 1 to 4. Higher scores are associated with higher perceptions of intervention acceptability, appropriateness, and feasibility.
Time Frame
3-6 months
Title
Intervention Satisfaction
Description
Participants receiving the Transitioning Together intervention will rate their satisfaction with each session on a self-reported satisfaction survey. Item scores range from 1 to 5. Higher scores are associated with a higher level of satisfaction.
Time Frame
At the conclusion of each group session
Title
Intervention Engagement
Description
Facilitators will rate participant engagement level after each Transitioning Together session to measure their level of engagement. Scores range from 1 to 5. Higher scores are associated with a higher level of engagement.
Time Frame
At the conclusion of each group session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria for youth: Age 14 to 21 years old Be enrolled in high school or a specialized continued schooling program for youth ages 18 to 21. Has been seen at BMC at least once since 2015 Confirmation of the autism diagnosis Currently live at home with a parent/legal guardian A parent/legal guardian who meets the below criteria Inclusion Criteria for parents: Age at least 21 years old Parent/legal guardian of a youth who meets the youth criteria Parent/legal guardian is comfortable reading, writing, speaking, and listening in English and/or Spanish Exclusion Criteria: A primary home language for the family is not English or Spanish (the intervention and assessments are only available in English and Spanish) The autistic youth currently resides independently, in supported housing, or with a foster family or other Department of Children and Families (DCF) placement Either the youth or their parent/guardian chooses not to participate in the study (one cannot participate without the other)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jocelyn L Kuhn, PhD
Phone
617-414-6373
Email
Jocelyn.Kuhn@bmc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Nina Menon, BA
Phone
617 414 6375
Email
nina.menon@bmc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jocelyn L Kuhn, PhD
Organizational Affiliation
Boston Medical Center, Pediatrics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jocelyn L Kuhn, PhD
Phone
617-414-6373
Email
Jocelyn.Kuhn@bmc.org

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
It is not yet known if there will be a plan to make IPD available.

Learn more about this trial

Transitioning Together Boston

We'll reach out to this number within 24 hrs