Autistic DisorderNCT03374072
Engaging Siblings of Adults With Autism in Future Planning
A study testing Siblings FORWARD program and Information Only Condition in people with Autistic Disorder, run by Boston University Charles River Campus at 1 site in United States.
Trial summary
The goal of this pilot study was to develop and obtain preliminary feasibility and effectiveness data of a telehealth program (Siblings FORWARD) to help siblings of autistic adults work with their families to plan for the future. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autistic Disorder
- What is being tested?
- Siblings FORWARD program and Information Only Condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 31 Aug 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Siblings of adults with autism spectrum disorder (ASD):
- Have one or more adult brother(s) or sister(s) with ASD who are either biologically related and/or were raised in the same family of origin (e.g., adopted, step, or foster siblings)
- Age 18+.
- English or Spanish fluency.
- Autistic Adults:
- Have an ASD diagnosis.
Show all 9Show fewer
- Have an adult sibling
- Age 21+.
- English or Spanish fluency if verbal.
Who cannot join
- Siblings of autistic adults:
- -Siblings will be excluded if they have an ASD diagnosis themselves or if they have any disability that would interfere with their ability to engage meaningfully in future planning for the autistic adult.
- Autistic adults:
- -None
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this pilot study was to develop and obtain preliminary feasibility and effectiveness data of a telehealth program (Siblings FORWARD) to help siblings of autistic adults work with their families to plan for the future. The main questions it aimed to answer were:
- Is the Siblings FORWARD program feasible to implement via telehealth in the community setting?
- Do siblings benefit from participation in the Siblings FORWARD program?
The Siblings FORWARD program involves 6-7 individualized telehealth sessions with a trained community facilitator. Researchers compared participation in the Siblings FORWARD program to an information-only control condition.
Read the detailed description
The researchers developed a program to facilitate the engagement of adult siblings to work with their families to plan for the future of their autistic sibling. Siblings FORWARD (Focusing on Relationships, Well-being, and Responsibility aheaD) targeted common barriers to sibling involvement in family future planning, including improving family communication around difficult topics, increasing siblings' knowledge of and confidence in accessing autism service systems, and anticipating and proactively problem-solving barriers to future planning. The Siblings FORWARD program was developed in collaboration with community organizations, with input from siblings, autistic adults, and community providers. Siblings FORWARD was implemented in a community setting, with trained program facilitators. A small randomized controlled trial tested participation in Siblings FORWARD compared to information about services only.
- Conditions
- Autistic Disorder
- Being tested
- Siblings FORWARD program, Information Only Condition
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Siblings FORWARD programBehavioural
Siblings will participate in a program developed by the researchers designed to engage adults with their autistic sibling and other family members to plan for the future. The Siblings FORWARD program will be implemented by community service providers already working with autistic adults. The program will involve a series individual and joint sessions with siblings and autistic adults using Zoom.
Information Only ConditionBehavioural
Siblings will be provided with online information about services for adults with ASD and future planning.
| Study group | Role | What they receive |
|---|---|---|
| Siblings FORWARD | Experimental | Siblings who participate in the Siblings FORWARD program will participate in telehealth sessions with a community provider. The Siblings FORWARD program includes 6-7 sessions, depending upon whether the autistic adult participates. Siblings work with a program facilitator to develop a future plan of action. They learn communication and problem-solving skills, and about adult service systems. Receives: Behavioral: Siblings FORWARD program |
| Information Only Condition | Active comparator | We will create an online learning module for siblings in the control condition. Siblings in the control condition will be provided with access to the same information about resources for autistic adults provided to participants in the Siblings FORWARD program. Receives: Behavioral: Information Only Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Sibling Plan of Action
Investigator developed. Siblings from both conditions submitted a written plan of action at pre- and post-intervention. The investigators used a template on which siblings detailed their short- and long-term goals with respect to planning for the future with their autistic sibling, and their concrete next steps. Blind ratings of the quality of each plan were conducted, according specific criteria that captured the appropriateness and specificity of the plan. Scores range from 0 to 9, with higher scores representing better quality of plan.
Measured: 4 months, 7 months
Secondary outcomes (5)
Family Communication About Future Planning
Adapted from a measure used by Heller and Caldwell (2006). Siblings rated the frequency with which they have had family discussions about planning for the future of regarding their autistic sibling. Adult sibling participants responded to a 1-item measure scored on a 3-point scale (not discussed at all, discussed somewhat, discussed a great deal). Higher scores reflect more frequent communication.
Measured: 4 months, 7 months
Future Planning Self-Efficacy
Adapted version of the Caregiver Self-Efficacy Scale used by Heller and Caldwell (2006). Sibling participants completed 5 items rated on a 4-point scale (strongly disagree to strong agree). Scores range from 5 to 20, with higher scores indicating higher self-efficacy.
Measured: 4 months, 7 months
Sibling Barriers to Future Planning
Adapted from a measure used by Heller and Caldwell (2006). Sibling participants complete a list of barriers to future planning that includes barriers such as: difficulty finding helpful contact persons within the service system, emotional barriers involved with thinking their parents' mortality, or disagreement with a relative with a disability about the future. Scores ranged from 0 to 12 with higher scores indicating more barriers reported.
Measured: 4 months, 7 months
Sibling Knowledge of Adult Services
Adapted from a measure used by Taylor and Seltzer (2011). Sibling participants rated their knowledge of the services received or needed by their autistic sibling. The investigators used a list of 15 adult services: physical therapy, occupational therapy, speech and language therapy, psychological or psychiatric services, crisis/intervention services, personal care assistance, agency sponsored recreational or social activities, transportation services, income support, vocational services, respite services, and Medicaid. Siblings rated whether or not their autistic sibling currently receives the services, or if they do not know. If they know that their autistic sibling is not receiving a service, they indicated whether or not that service is needed. Scores ranged from 0 to 15 with higher scores indicating more knowledge.
Measured: 4 months, 7 months
Sibling Knowledge of Family Future Plan
Investigator developed. Siblings completed a checklist of their knowledge (yes/no/ don't know) of whether their family has established: (1) a will, (2) a special needs trust, (3), a financial plan; (4) a letter of intent; (5) a long-term residential plan; or (6) determination of future guardianship. Scores range from 0 to 6 with a high score indicating more areas addressed
Measured: 4 months, 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study start1 Feb 2017
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
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 Autistic 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Gael Orsmond, Boston University Charles River Campus
- Investigators
- Gael Orsmond, PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03374072
- Sponsor's protocol ID
- 4366E
- Other IDs
- R34MH111489
- Status last verified
- Feb 2023
- First submitted
- 5 Dec 2017
- Last updated
- 7 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Siblings of Adults With Autism in Future Planning
- ClinicalTrials.gov ID
- NCT03374072
- Acronym / sponsor ID
- 4366E
- Conditions
- Autistic Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 15 Dec 2017 (actual)
- Results
- Posted 7 Mar 2023
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 pilot study was to develop and obtain preliminary feasibility and effectiveness data of a telehealth program (Siblings FORWARD) to help siblings of autistic adults work with their families to plan for the future. The main questions it aimed to answer were:
- Is the Siblings FORWARD program feasible to implement via telehealth in the community setting?
- Do siblings benefit from participation in the Siblings FORWARD program?
The Siblings FORWARD program involves 6-7 individualized telehealth sessions with a trained community facilitator. Researchers compared participation in the Siblings FORWARD program to an information-only control condition.
Detailed description
The researchers developed a program to facilitate the engagement of adult siblings to work with their families to plan for the future of their autistic sibling. Siblings FORWARD (Focusing on Relationships, Well-being, and Responsibility aheaD) targeted common barriers to sibling involvement in family future planning, including improving family communication around difficult topics, increasing siblings' knowledge of and confidence in accessing autism service systems, and anticipating and proactively problem-solving barriers to future planning. The Siblings FORWARD program was developed in collaboration with community organizations, with input from siblings, autistic adults, and community providers. Siblings FORWARD was implemented in a community setting, with trained program facilitators. A small randomized controlled trial tested participation in Siblings FORWARD compared to information about services only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Siblings FORWARD | Experimental | Behavioral: Siblings FORWARD programSiblings who participate in the Siblings FORWARD program will participate in telehealth sessions with a community provider. The Siblings FORWARD program includes 6-7 sessions, depending upon whether the autistic adult participates. Siblings work with a program facilitator to develop a future plan of action. They learn communication and problem-solving skills, and about adult service systems. |
| Information Only Condition | Active comparator | Behavioral: Information Only ConditionWe will create an online learning module for siblings in the control condition. Siblings in the control condition will be provided with access to the same information about resources for autistic adults provided to participants in the Siblings FORWARD program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Have one or more adult brother(s) or sister(s) with ASD who are either biologically related and/or were raised in the same family of origin (e.g., adopted, step, or foster siblings)
- Age 18+.
- English or Spanish fluency.
- Have an ASD diagnosis.
- Have an adult sibling
Key exclusion criteria (4 listed)
- -Siblings will be excluded if they have an ASD diagnosis themselves or if they have any disability that would interfere with their ability to engage meaningfully in future planning for the autistic adult.
- -None
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 |
|---|---|---|
| Siblings FORWARD programSiblings will participate in a program developed by the researchers designed to engage adults with their autistic sibling and other family members to plan for the future. The Siblings FORWARD program will be implemented by community service providers already working with autistic adults. The program will involve a series individual and joint sessions with siblings and autistic adults using Zoom. | Behavioural | Siblings FORWARD |
| Information Only ConditionSiblings will be provided with online information about services for adults with ASD and future planning. | Behavioural | Information Only Condition |
Primary outcome
Quality of Sibling Plan of Action
Time frame: 4 months, 7 months
Investigator developed. Siblings from both conditions submitted a written plan of action at pre- and post-intervention. The investigators used a template on which siblings detailed their short- and long-term goals with respect to planning for the future with their autistic sibling, and their concrete next steps. Blind ratings of the quality of each plan were conducted, according specific criteria that captured the appropriateness and specificity of the plan. Scores range from 0 to 9, with higher scores representing better quality of plan.
5 secondary outcomes
Family Communication About Future Planning
Time frame: 4 months, 7 months
Future Planning Self-Efficacy
Time frame: 4 months, 7 months
Sibling Barriers to Future Planning
Time frame: 4 months, 7 months
Sibling Knowledge of Adult Services
Time frame: 4 months, 7 months
Sibling Knowledge of Family Future Plan
Time frame: 4 months, 7 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Gael Orsmond, PhD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Siblings FORWARD program and Information Only Condition in people with Autistic Disorder, 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 9 inclusion and 4 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 7 Mar 2023. 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 7 Mar 2023). 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?
Quality of Sibling Plan of Action (time frame: 4 months, 7 months). 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 7 Mar 2023.