Autism Spectrum DisorderNCT05965648
Development of a Family-Based Transition Planning Program for Culturally-Diverse Youth on the Autism Spectrum
A study testing Families FORWARD (Focusing on Relationships, Well-being, and Responsibility aheaD) in people with Autism Spectrum Disorder and Family Relations, run by Boston University Charles River Campus at 1 site in United States.
Trial summary
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: 1. To develop the Families FORWARD program 2. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Family Relations
- What is being tested?
- Families FORWARD (Focusing on Relationships, Well-being, and Responsibility aheaD)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2023to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Family Inclusion Criteria
- Parents or primary caregivers of transition-aged youth on the autism spectrum:
- Have one or more child(ren) on the autism spectrum who is/are ages 14-21 years old
- Identify as the parent, legal guardian, and/or primary caregiver of the youth
- Speak English fluently
- Reside in Massachusetts
Show all 11Show fewer
- Youth on the autism spectrum:
- Have an autism diagnosis OR identify as autistic
- Age 14-21
- Have ability to communicate verbally or in written format in English
- Reside in Massachusetts
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Families FORWARD: Development of a Family-Based Transition Planning Program for Culturally-Diverse Youth on the Autism Spectrum
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:
- To develop the Families FORWARD program
- To conduct proof-of-concept testing of the Families FORWARD program
Participants will complete surveys before and after participating in the program and will participate in exit interviews at the end of the program.
Read the detailed description
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.
- Conditions
- Autism Spectrum Disorder, Family Relations
- Being tested
- Families FORWARD (Focusing on Relationships, Well-being, and Responsibility aheaD)
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Families FORWARD (Focusing on Relationships, Well-being, and Responsibility aheaD)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Families FORWARD (Focusing on Relationships, Well-being, and Responsibility aheaD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Within 2 weeks post-intervention (i.e., 3-4 months after enrollment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start2 Sep 2023
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Autism Spectrum DisorderStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Deborah Munroe Noonan Memorial Research Fund
- Responsible party
- Principal investigator, Kristin Long, Boston University Charles River Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965648
- Sponsor's protocol ID
- 6444E
- Status last verified
- Jan 2026
- First submitted
- 28 Jun 2023
- Last updated
- 13 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 individual participant data (IPD) available.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Families FORWARD: Development of a Family-Based Transition Planning Program for Culturally-Diverse Youth on the Autism Spectrum
- ClinicalTrials.gov ID
- NCT05965648
- Acronym / sponsor ID
- 6444E
- Conditions
- Autism Spectrum Disorder, Family Relations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- Deborah Munroe Noonan Memorial Research Fund
- Study start
- 2 Sep 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 28 Jul 2023 (actual)
- Results
- Posted 13 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To develop the Families FORWARD program
- To conduct proof-of-concept testing of the Families FORWARD program
Participants will complete surveys before and after participating in the program and will participate in exit interviews at the end of the program.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Families FORWARD | Other | Behavioral: Families FORWARD (Focusing on Relationships, Well-being, and Responsibility aheaD)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. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Family Inclusion Criteria
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| 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 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). | Behavioural | Families FORWARD |
Primary outcome
Families FORWARD Program Acceptability Form
Time frame: Within 2 weeks post-intervention (i.e., 3-4 months after enrollment).
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.
Transition Planning Activities Measure
Time frame: Within 2 weeks post-intervention (i.e., 3-4 months after enrollment).
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. It is not yet known if there will be a plan to make individual participant data (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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Families FORWARD (Focusing on Relationships, Well-being, and Responsibility aheaD) in people with Autism Spectrum Disorder and Family Relations, run by Boston University Charles River Campus 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 11 inclusion and 0 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: finished, as of the sponsor's last update on 13 Feb 2026. 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?
Yes. Results are posted in the registry (first posted 13 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Families FORWARD Program Acceptability Form (time frame: Within 2 weeks post-intervention (i.e., 3-4 months after enrollment).). The study lists 2 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 13 Feb 2026.