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| Name | Class |
|---|---|
| Deborah Munroe Noonan Memorial Research Fund | OTHER |
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The goal of this clinical study is to develop a community-based program to support family members of transition-aged youth on the autism spectrum to help them plan for the future. The main aims of the study are:
Participants will complete surveys before and after participating in the program and will participate in exit interviews at the end of the program.
The Families FORWARD (Focusing on Relationships, Well-being, and Responsibility aheaD) program aims to increase family members' active planning for the transition to adulthood in the context of autism. The program is designed to enable flexible delivery for families of youth who are diverse across autism features, co-occurring conditions, service needs, cultural values and preferences, and readiness to engage in planning. The program will be delivered collaboratively with community organizations that support individuals on the autism spectrum and/or their families.
The current project aims to conduct proof-of-concept testing with a culturally-diverse sample of families of transition-aged youth on the autism spectrum. Parents / primary caregivers will participate in 6-7 individual, personalized sessions that incorporate aspects of skill-building (communication, goal-setting, problem-solving, systems navigation), education about services, and motivational interviewing. Youth will be invited to participate in 3 of the sessions along with their parent / primary caregiver. Participants will complete surveys before and after participating in the program and will participate in exit interviews at the end of the program. The investigators will assess indicators of acceptability, feasibility, and improvement on proposed mediators and outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Families FORWARD | Other | This is a single-arm trial of a new transition planning program for families of youth on the autism spectrum. The program includes six or seven bi-weekly parent sessions, three of which are optional for the youth to attend. The program will be facilitated by community-based service providers who work with transition-aged youth on the autism spectrum and/or their families. Baseline characteristics were not collected for service providers. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Families FORWARD (Focusing on Relationships, Well-being, and Responsibility aheaD) | Behavioral | Families FORWARD aims to engage families in planning for adulthood earlier and more actively. Program skills include communication and problem-solving; guided practice in setting realistic goals, breaking down goals into incremental action steps, and problem-solving barriers to goal attainment; repeated engagement in future-oriented communication; and training on how to navigate transition-related and adult services. Parents/caregivers will participate in six or seven telehealth sessions (60-75 minutes each). Youth on the autism spectrum will have the option of participating in up to three program sessions to increase collaborative planning within the family. Families will identify and work toward individualized transition planning goals that may fall within any area of planning or functioning (e.g., housing, education, guardianship). |
| Measure | Description | Time Frame |
|---|---|---|
| Families FORWARD Program Acceptability Form | Parents/caregivers (and youth, when applicable) completed the Program Acceptability scale which assess acceptability, appropriateness, and feasibility of the FamiliesFORWARD program. Item scores range from 1 to 5. The measure was scored by a total summation; total scores range from 12 to 60. Higher scores are associated with higher perceptions of intervention acceptability, appropriateness, and feasibility. | Within 2 weeks post-intervention (i.e., 3-4 months after enrollment). |
| Transition Planning Activities Measure | The Transition Preparation Activities Measure (T-PAM) was the outcome measure used to assess parents' readiness for their youth's transition to adulthood after completing the Families FORWARD intervention. Item scores range from 1 to 5. Total scores on the measure range from 14 to 70, with higher scores associated with higher transition readiness. Parents/caregivers completed an online version of the T-PAM following completion of the Families FORWARD intervention. | Within 2 weeks post-intervention (i.e., 3-4 months after enrollment). |
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Inclusion Criteria:
Family Inclusion Criteria
Parents or primary caregivers of transition-aged youth on the autism spectrum:
Youth on the autism spectrum:
Exclusion Criteria: none
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston University | Boston | Massachusetts | 02215 | United States |
It is not yet known if there will be a plan to make individual participant data (IPD) available.
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| ID | Title | Description |
|---|---|---|
| FG000 | Families FORWARD | This is a single-arm trial of a new transition planning program for families of youth on the autism spectrum. The program includes six or seven bi-weekly parent sessions, three of which are optional for the youth to attend. The program will be facilitated by community-based service providers who work with transition-aged youth on the autism spectrum and/or their families. Families FORWARD (Focusing on Relationships, Well-being, and Responsibility aheaD): Families FORWARD aims to engage families in planning for adulthood earlier and more actively. Program skills include communication and problem-solving; guided practice in setting realistic goals, breaking down goals into incremental action steps, and problem-solving barriers to goal attainment; repeated engagement in future-oriented communication; and training on how to navigate transition-related and adult services. Parents/caregivers will participate in six or seven telehealth sessions (60-75 minutes each). Youth on the autism spectrum will have the option of participating in up to three program sessions (25-40 minutes each) to increase collaborative planning within the family. Families will identify and work toward individualized transition planning goals that may fall within any area of planning or functioning (e.g., housing, education, guardianship). Data pertaining to service providers was not collected in the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Aug 21, 2023 |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm/Group Title: Families FORWARD Parents/Caregivers | Parents/caregivers participated in six or seven telehealth sessions (60-75 minutes each) in which they identified and worked toward individualized transition planning goals that may fall within any area of planning or functioning (e.g., housing, education, guardianship) for their youth adult. |
| BG001 | Arm/Group Title: Families FORWARD Youth | Youth on the autism spectrum had the option of participating in up to three program sessions (25-40 minutes each) to increase collaborative planning within the family. Families identified and worked toward individualized transition planning goals that may fall within any area of planning or functioning (e.g., housing, education, guardianship). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Data pertaining to youth sex was not collected in the study. | Data pertaining to youth sex was not collected in the study. | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Data pertaining to youth race/ethnicity was not collected in the study. | Data pertaining to youth sex was not collected in the study. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Transition Preparation Activities Measure (T-PAM) | The Transition Preparation Activities Measure (T-PAM) was the baseline measure used to assess parents' readiness for their youth's transition to adulthood in the study. Item scores range from 1 to 5. Total scores on the measure range from 14 to 70; higher scores are associated with higher transition readiness. Parents/caregivers completed an online version of the T-PAM prior to completing the Families Forward intervention. Youth participants did not complete this measure. | In the study, only parents/caregivers completed the T-PAM measure. | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Families FORWARD Program Acceptability Form | Parents/caregivers (and youth, when applicable) completed the Program Acceptability scale which assess acceptability, appropriateness, and feasibility of the FamiliesFORWARD program. Item scores range from 1 to 5. The measure was scored by a total summation; total scores range from 12 to 60. Higher scores are associated with higher perceptions of intervention acceptability, appropriateness, and feasibility. | Only participants who completed the program provided data on this measure. | Posted | Mean | Standard Deviation | score on a scale | Within 2 weeks post-intervention (i.e., 3-4 months after enrollment). |
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| Primary | Transition Planning Activities Measure | The Transition Preparation Activities Measure (T-PAM) was the outcome measure used to assess parents' readiness for their youth's transition to adulthood after completing the Families FORWARD intervention. Item scores range from 1 to 5. Total scores on the measure range from 14 to 70, with higher scores associated with higher transition readiness. Parents/caregivers completed an online version of the T-PAM following completion of the Families FORWARD intervention. | Posted | Mean | Standard Deviation | score on a scale | Within 2 weeks post-intervention (i.e., 3-4 months after enrollment). |
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Adverse event data were collected through study completion, over 8 months.
No participants were determined to be at risk for All-Cause Mortality.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Families FORWARD | This is a single-arm trial of a new transition planning program for families of youth on the autism spectrum. The program includes 6 or 7 bi-weekly parent sessions, three of which are optional for the youth to attend. Families FORWARD (Focusing on Relationships, Well-being, and Responsibility aheaD): Families FORWARD aims to engage families in planning for adulthood earlier and more actively. Program skills include communication and problem-solving; guided practice in setting realistic goals, breaking down goals into incremental action steps, and problem-solving barriers to goal attainment; repeated engagement in future-oriented communication; and training on how to navigate transition-related and adult services. Parents/caregivers will participate in six or seven telehealth sessions (60-75 minutes each). Youth on the autism spectrum will have the option of participating in up to three program sessions (25-40 minutes each) to increase collaborative planning within the family. Families will identify and work toward individualized transition planning goals that may fall within any area of planning or functioning (e.g., housing, education, guardianship). Information pertaining to adverse events that took place for youth and caregivers during the study are combined in their presentation given that there was no significant difference in study protocol for both classification of participants that would result in significantly different exposure or experience of adverse events. | 0 | 27 | 0 | 27 | 0 | 27 |
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Outcomes reflect data from a proof of concept trial regarding the FamiliesFORWARD program, which was not designed to measure statistically significant results.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kristin Long | Boston University | (617)-358-1633 | KALong@bu.edu |
| Jan 13, 2026 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
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| D000067877 | Autism Spectrum Disorder |
| ID | Term |
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| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
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| D006262 | Health |
| ID | Term |
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| D011154 | Population Characteristics |
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