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Autism Spectrum DisorderMtGNCT03711799

Mind the Gap (AIR-B3)

A study testing Access to services via peer coaching in people with Autism Spectrum Disorder, run by Health Resources and Services Administration (HRSA) at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

There has been a lack of research on the unique needs of families with autism in the African-American and Latino communities. The process of screening, evaluation and treatment for children with autism can be long and arduous, especially in these communities. Read more about this study

Who is it for?
Ages 2 years and olderHealthy volunteers can take part
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
Access to services via peer coaching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
156 participants
Where
3 sitesUnited States
Study dates
1 Apr 2018to 31 Aug 2020
Phase
Interventional
Are there results?
None posted in the registry

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 2 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Parent Inclusion Criteria:

  • child under 9 years of age with a diagnosis of ASD
  • no receipt of ASD specific services outside of school (family may still qualify if child is connected with a regional center/EI, but not yet receiving services), defined as (a) services obtained through insurance based on having an ASD diagnosis;or (b) receiving services through 0-3 that can only be accessed with an ASD dx (e.g., intensive in home EIBI)
  • family income is under 250% of the federal guidelines for poverty rate
  • English or Spanish speaking.

Peer Coach Inclusion criteria:

  • parent of a child with autism or other similar developmental disorder
  • a child over 9 years old and at least 5 years post-diagnosis
  • some experience working with parents and/or understanding of the service system and
  • fluent in English and/or Spanish.

Parent Exclusion Criteria:

  • child is in out-of-home placement or foster care.

Peer Coach Exclusion Criteria:

  • Cannot commit to the times and requirements of the study.

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • UC Davis

    Davis, California, 95817

  • UPENN

    Philadelphia, Pennsylvania, 19104-2648

  • University of Rochester

    Rochester, New York, 14642

Other trials in United States

About this study

Official title: Mind the Gap Intervention

There has been a lack of research on the unique needs of families with autism in the African-American and Latino communities. The process of screening, evaluation and treatment for children with autism can be long and arduous, especially in these communities. This often means that the best interventions for children with autism are not reaching minority communities. For many families, the complexity of the services system leads to a long wait after the initial diagnosis before accessing intervention. This means that the children have delayed access to treatment. Mind the Gap is a study that seeks to provide immediate and culturally appropriate support for families who have just received diagnosis but have yet to receive treatment. This support will be provided in families' native languages and, through the use of phone and video sessions, can accommodate busy schedules. Mind the Gap participants will be randomized to receive one of two conditions, which are 1.Resources only (online training modules and paper or on line resource lists, but no peer coaching) 2. Peer coaching (will receive all online training access). The peer coaches will be recruited from local parent support agencies. They will not be professionals in the field of ASD, but they will be trained by the research group on how to access the online tools and how to work whith families. They will contact the participants via phone or video conference on a weekly basis and an in- person visit per month for 3 months. Peer coaches will have a monthly call with participants for an additional nine months.We hope that this study will help the African American and Latino communities receive services sooner than currently reported. We also hope that in the future, parent organizations will use these tools to help families that have recently received an ASD diagnosis will us navigate the complex system of attaining services.

Read the detailed description

We will recruit 140 (35 per site) families that will be referred by pediatricians, school staff, family resource centers, early intervention agencies, DDS or self-referred using study referral form, phone or web based referral system. The referral will include consent to be contacted by the research team. All families will complete the screening survey by phone (Section 19.2, item 3.1) with a member of the research team. This will be the only survey that will determine eligibility. If eligible to participate, the participants will be asked to give an oral consent. The oral consent will allow the research team to randomize the family to either the Resource Only Group or the Peer Coaching Group. For both conditions, a written consent will be later obtained when the research team meets with the families for the intake survey and filling out the measures: Demographic, Family Empowerment Scale, Caregiver Agency Questionnaire, Caregiver Autism Knowledge Questionnaire, Caregiver Stigma Scale and a Satisfaction Survey only at end of study. Cultural Capital Survey will only be used once at the intake survey meeting.

Parents will have access to ParentSquare, a safe, secure platform for program-to-parent and parent-to-parent communication. ParentSquare has a registration feature where parents can complete forms and sign up for courses and training modules and to broadcast training. Parents can choose to be notified via text, email with reminders or updates through the app. Messages can be private or broadcasted to larger group. There is also a document feature to allow shared access between parent and coach of parent goals and progress between calls and visits. Each site will be responsible for monitoring communication of their participants in Parent Square along with Drexel University.

Participants will also include up to 40 peer coaches (10 per site) who will be trained to provide coaching to families for 5 months as a family gains access to services. Peer Coach Inclusion criteria: (1) parent of a child with autism or other similar developmental disorder; (2) a child over 9 years old and at least 5 years post-diagnosis; (3) some experience working with parents and/or understanding of the service system and (4) fluent in English and/or Spanish.

Intervention Resource only. Families randomized to the resource only condition will have access to training materials in web-based and paper formats. The will receive the internet address to access web-based trainings, handouts and materials, including instructions for each activity and they will receive a binder that includes the information that is available on line so they can access the information even if they do not have internet access Families in the resource only condition will not have access to a peer coach through the program. They will not have access to the on-line support community.

Peer Coaching Condition. Families randomized to peer coaching will receive assistance with navigating the training program and accessing the system from a trained peer parent coach. Peer coaches will, as much as possible, be culturally and language-matched with the participant family. Families in this condition will receive a call from their peer coach who will set up an initial, in-person meeting either in-home, clinic or community setting depending on the participant preference. Based on the goal setting interview the peer coach and the family will choose initial goals to complete in the first week, which will include (1) completion of a training (typically the What is ASD? Training will be completed first); (2) completion of one activity related to service access (e.g., phone access; call to service provider; form completion); and (3) one self-care activity. A timeline for goals will be developed together based on the family needs. Peer coaches will have a guide for rating the importance of training and materials for the family based on the interview, and a guide which will identify triggers (e.g. challenging behavior, safety concerns) to increase the level of care. Peer coaches will set up a weekly call or video conferences (based on parent preference), and monthly in person visit with the family to assess goal progress, provide information, and set up subsequent goals and/or additional support if needed. Monthly visits and weekly calls will continue for 12 visits up to 4 months). If parents choose to meet via video conference, a secure, University approved method will be used by coaches (e.g., Zoom, Skype, Webex). Three of the calls will be audio recorded for research purposes and to provide feedback to the coaches. Calls will then be reduced to monthly for 9 months. Parent participants can contact the peer coach at any time as well. Peer coaches will have a script and materials for each call which will cover a specific topic identified with the family. Peer coaches will have bi monthly supervision.

Peer Coach Training. Peer coaches will be hired or referred from local parent support agencies . Compensation will be specific to each site. Peer coaches are parents of children with ASD diagnosed at least 5 years ago, fluent in English or Spanish and have some experience helping other families of children with ASD.

Peer coaches will attend four, 3-hour training sessions in the use of the intervention materials. They will have a chance to practice using the materials and will learn about issues related to safety and how to work with families. They will complete citi training and additional training and role play in the confidentiality. Training will include learning to use Parentsquare and role playing interviewing and discussing topics with families. Coaches will have access to scripts for each potential topic and resources to address family needs. Parent engagement in the intervention will also be measured by (1) enrollment in sessions; (2) attendance at sessions and peer coach calls/meetings; (3) accessing on-line materials; (4) completion of on-line trainings; and (5) project attrition.

Peer coaches will be expected to provide a 24-hour notice if they need to cancel a meeting or session. They will also be expected to reschedule missed appointments. Also, peer coaches will not be paid for missed appointments. If the peer coaches misses 3 meetings in a row without proper cancellation, a member of the research team will have to resume his/her activities.

Being tested
Access to services via peer coaching
Keywords
Autism Services, Mind the Gap, Peer Coach
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.

  • Access to services via peer coachingBehavioural

    This intervention will allow for half of the participants, randomly selected, to get help navigating the system of acquiring services for their child. These participants will be assisted by a coach who are also parents of a child with autism and have already been through the process.

Study groups in NCT03711799
Study groupRoleWhat they receive
Resource Only GroupNo interventionFamilies randomized to the resource only condition will have access to training materials in web-based and paper formats. The will receive the internet address to access web-based trainings, handouts and materials, including instructions for each activity and they will receive a binder that includes the information that is available on line so they can access the information even if they do not have internet access. Families in the resource only condition will not have access to a peer coach through the program. They will not have access to the on-line support community.
Peer Coaching GroupExperimentalFamilies randomized to peer coaching will receive assistance with navigating the training program and accessing the system from a trained peer parent coach. Peer coaches will, as much as possible, be culturally and language-matched with the participant family.
Receives: Behavioral: Access to services via peer coaching

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Service Access Form from month to month

    This form was created within the research group. It is used monthly after entry to document the services the participants would like to get and the ones they are currently receiving.

    Measured: Monthly from baseline and up to a year after baseline

Secondary outcomes (7)
  1. Family Empowerment Scale (Koren, DeChillo & Friesen, 1992)

    It is a 34-item rating scale that measures empowerment in families with children who have emotional, behavioral, or developmental disorders. The FES has three subscales, Family, Service System and, Social Politics. Parents rated each item on a 5-point Likert-type rating scale.

    Measured: baseline, 4 months, 8 months and a year after baseline

  2. Caregiver Agency Questionnaire (adapted from Kuhn & Carter, 2006)

    It is a 20 item survey about how often the parent engaged in certain activities related to promoting child development. For each question responses are on a Likert scale from 1=never to 5=almost always. Ten questions related to items targeted in the intervention were chosen, with assistance from one of the developers (Dr. Carter).

    Measured: baseline, 4 months, 8 months and a year after baseline

  3. Caregiver Autism Knowledge Questionnaire (adapted, Kuhn & Carter, 2006)

    It is a 43-item true/false questionnaire that measures knowledge of facts about autism in the areas of diagnosis, symptoms, treatments and interventions, and etiology. To reduce burden we have chosen 10 questions representative of information provided in the intervention and approved by the survey author (Dr. Carter) . Caregivers will respond to each true/false item.

    Measured: baseline, 4 months, 8 months and a year after baseline

  4. Caregiver Stigma Scale (McKay & Cavaleri, 2009)

    It is an 11-item scale adapted from McKay and Cavaleri (2009) that measures the degree of stigma that caregivers have about receiving professional services or treatment for their child from a mental health or developmental specialist (e.g. developmental pediatrician, psychologist, psychiatrist). Caregivers will utilize a 5-point Likert-type rating scale to rate the extent to which they agreed with statements regarding beliefs about accessing professional services for their child (e.g. "I believe that there is something wrong with children who get professional services or treatment").

    Measured: baseline, 4 months, 8 months and a year after baseline

  5. Satisfaction Survey

    This survey was created by the research team. At 4 months post entry, caregivers will rate their satisfaction with the intervention on a survey that utilizes a 5-point Likert-type rating scale.

    Measured: 4 months post baseline

  6. Community Capital Scale

    This survey measures how each parent's community involvement/importance influences their behavior. It was created by a member of the research group.

    Measured: baseline

  7. Social Dynamics of Intervention_ASD (Autism Spectrum Disorder)-SoDI

    This measure shows the level of support the parent has with his/her child with autism.

    Measured: baseline, 4 months, 8 months and a year after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2018
  2. Study start1 Apr 2018
  3. Primary completion1 Aug 2020
  4. Study completion31 Aug 2020

Resources

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
156 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03711799
Sponsor's protocol ID
17-000029
Acronym
MtG
Status last verified
Feb 2022
First submitted
12 Oct 2018
Last updated
9 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Caruthers C, Hochheimer S, Pellecchia M, Gulsrud A, Hassrick EM, Mandell D, Stahmer A, Kasari C, Iadarola S. Comparison of Natural Language Processing and Traditional Qualitative Analyses of Caregiver Feedback From a Community-Based Intervention for Children With Autism. J Eval Clin Pract. 2026 Oct;32(7):e70667. doi: 10.1111/jep.70667.

    PubMed 42862943
  • Iadarola S, Pellecchia M, Stahmer A, Lee HS, Hauptman L, Hassrick EM, Crabbe S, Vejnoska S, Morgan E, Nuske H, Luelmo P, Friedman C, Kasari C, Gulsrud A, Mandell D, Smith T. Mind the gap: an intervention to support caregivers with a new autism spectrum disorder diagnosis is feasible and acceptable. Pilot Feasibility Stud. 2020 Sep 7;6:124. doi: 10.1186/s40814-020-00662-6. eCollection 2020.

    PubMed 32944273

Questions about this trial

What is this clinical trial studying?

A study testing Access to services via peer coaching in people with Autism Spectrum Disorder, run by Health Resources and Services Administration (HRSA) at 3 sites 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?

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 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 Service Access Form from month to month (time frame: Monthly from baseline and up to a year after baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03711799, which also lists 2 linked publications.

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 9 Feb 2022.

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