Autism or Autistic TraitsNCT05599711
Transitioning Together Boston
A study testing Transitioning Together (TT) / Juntos en la Transicion (JET) and Usual autism transition care in people with Autism or Autistic Traits and Family Relations, run by Boston Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 21 years
- Conditions the study is for
- Autism or Autistic Traits, Family Relations
- What is being tested?
- Transitioning Together (TT) / Juntos en la Transicion (JET) and Usual autism transition care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2023to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing the Efficacy of an Adapted Family-Centered Autism Transition Intervention in a Safety Net Hospital Setting
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.
Read the 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.
- Conditions
- Autism or Autistic Traits, Family Relations
- Being tested
- Transitioning Together (TT) / Juntos en la Transicion (JET), Usual autism transition care
- 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
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transitioning Together (TT) / Juntos en la Transicion (JET)Behavioural
- 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.
Usual autism transition careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Transitioning Together | Experimental | 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. Receives: Behavioral: Transitioning Together (TT) / Juntos en la Transicion (JET) |
| Usual Care | Active comparator | 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. Receives: Behavioral: Usual autism transition care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3-12 months
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.
Measured: Baseline, 3-12 months
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.
Measured: Baseline, 3-12 months
Secondary outcomes (7)
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.
Measured: Baseline, 3-12 months
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.
Measured: Baseline, 3-12 months
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.
Measured: Baseline, 3-12 months
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.
Measured: Baseline, 3-12 months
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.
Measured: Baseline, 3-12 months
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.
Measured: Baseline, 3-12 months
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.
Measured: Baseline, 3-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start10 Feb 2023
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism or Autistic TraitsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Deborah Munroe Noonan Memorial Research Fund
- Responsible party
- Sponsor
- Investigators
- Jocelyn L Kuhn, PhD, Principal investigator, Emory School of MedicineMei Elansary, MD, Principal investigator, Boston Medical Center, Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599711
- Sponsor's protocol ID
- H-43047
- Status last verified
- Nov 2025
- First submitted
- 26 Oct 2022
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not yet known if there will be a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Efficacy of an Adapted Family-Centered Autism Transition Intervention in a Safety Net Hospital Setting
- ClinicalTrials.gov ID
- NCT05599711
- Acronym / sponsor ID
- H-43047
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Deborah Munroe Noonan Memorial Research Fund
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 31 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transitioning Together | Experimental | Behavioral: Transitioning Together (TT) / Juntos en la Transicion (JET)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. |
| Usual Care | Active comparator | Behavioral: Usual autism transition careParticipants 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. |
Who may qualify
- Ages
- 14 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transitioning Together (TT) / Juntos en la Transicion (JET)1. 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. 2. 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. | Behavioural | Transitioning Together |
| Usual autism transition careAn 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. | Behavioural | Usual Care |
Primary outcome
Change in quality of life of autistic youth
Time frame: Baseline, 3-12 months
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
Time frame: Baseline, 3-12 months
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
Time frame: Baseline, 3-12 months
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.
7 secondary outcomes
Change in family empowerment
Time frame: Baseline, 3-12 months
Change in coping
Time frame: Baseline, 3-12 months
Change in social support
Time frame: Baseline, 3-12 months
Change in perceived burden
Time frame: Baseline, 3-12 months
Change in parental well-being
Time frame: Baseline, 3-12 months
Change in family climate
Time frame: Baseline, 3-12 months
Change in transition readiness
Time frame: Baseline, 3-12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: No. It is not yet known if there will be a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jocelyn L Kuhn, PhD principal investigator
Emory School of Medicine
Mei Elansary, MD principal investigator
Boston Medical Center, Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transitioning Together (TT) / Juntos en la Transicion (JET) and Usual autism transition care in people with Autism or Autistic Traits and Family Relations, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quality of life of autistic youth (time frame: Baseline, 3-12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.