Transitioning Together Boston

Family Relations Clinical Trial

Official title:

Testing the Efficacy of an Adapted Family-Centered Autism Transition Intervention in a Safety Net Hospital Setting

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05599711
• Other study ID #: H-43047
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2023
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Boston Medical Center
• Contact: Mei L Elansary, MD
• Phone: 617-414-6373
• Email: mei.elansary[@]bmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 256
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 21 Years

Eligibility

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)

Related Conditions & MeSH terms

• Autistic Disorder
• Family Relations

Intervention

Behavioral:
• Transitioning Together (TT) / Juntos en la Transicion (JET)
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 care
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.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	Deborah Munroe Noonan Memorial Research Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intervention acceptability, appropriateness, and feasibility	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.	3-12 months
Other	Intervention Satisfaction	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.	At the conclusion of each group session
Other	Intervention Engagement	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.	At the conclusion of each group session
Primary	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.	Baseline, 3-12 months
Primary	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.	Baseline, 3-12 months
Primary	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.	Baseline, 3-12 months
Secondary	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.	Baseline, 3-12 months
Secondary	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.	Baseline, 3-12 months
Secondary	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.	Baseline, 3-12 months
Secondary	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.	Baseline, 3-12 months
Secondary	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.	Baseline, 3-12 months
Secondary	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.	Baseline, 3-12 months
Secondary	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.	Baseline, 3-12 months