Autism Spectrum DisorderAPNNCT04744428
Trial of Autism Parent Navigator Program
A study testing Autism Parent Navigators and Peer mentoring in people with Autism Spectrum Disorder, run by Penn State University at 1 site in United States.
Trial summary
To address the dual needs of parents for support in navigating Autistic Spectrum Disorder (ASD) services and maintaining positive family functioning, the investigators propose to test Autism Parent Navigators (APN), an innovative in-home, peer support model for parents with a young child recently diagnosed with ASD. 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?
- Autism Parent Navigators and Peer mentoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 388 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2021to 1 Jun 2026
- 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
Who may be able to join
- Parents of children who have been newly diagnosed with Autism Spectrum Disorder (ASD).
- The child will be age 2-6 years and been diagnosed with ASD in the past four months.
- The child is the first child in the family to be diagnosed with ASD.
- Parents are not already involved in a parent mentoring relationship.
- Parents are currently involved in a couple relationship, including same-sex partners, dating couples, adoptive parents and step-parent families.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Test of an Innovative, Scalable Support Program for Parents With a Young Child Recently Diagnosed With Autism Spectrum Disorder
To address the dual needs of parents for support in navigating Autistic Spectrum Disorder (ASD) services and maintaining positive family functioning, the investigators propose to test Autism Parent Navigators (APN), an innovative in-home, peer support model for parents with a young child recently diagnosed with ASD.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Autism Parent Navigators, Peer mentoring
- 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.
Autism Parent NavigatorsBehavioural
The Autism Parent Navigator program consists of six sessions delivered to parents in the home, supporting adjustment to ASD, accessing services, and coparenting support.
Peer mentoringBehavioural
Six in-home or telephone sessions, depending on family uptake, providing non-manualized general support as usual from parent peer mentors regarding adjustment to ASD.
| Study group | Role | What they receive |
|---|---|---|
| Autism Parent Navigators Intervention | Experimental | Autism Parent Navigators Intervention is a manualized, in-home, peer support model for parents with a young child recently diagnosed with ASD. Receives: Behavioral: Autism Parent Navigators |
| Peer mentoring | Active comparator | Peer mentors will offer an equivalent number of in-home or telephone visits for families, providing non-manualized peer support. Receives: Behavioral: Peer mentoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly Count of Service Navigation Behaviors
Engagement with ASD-related Services
Measured: 12 month
Parenting Scale (Arnold)
Parenting consistency, warmth
Measured: 12 month
CES-Depression
Parent depression
Measured: 12 month
Secondary outcomes (3)
Coparenting Relationship Scale (Feinberg, Brown, & Kan, 2012)
Coparenting Support
Measured: 12 month
Family Empowerment Scale - FES
Parent Efficacy regarding Service Access
Measured: 12 month
PDD-BI
Challenging Child Behaviors: Aggression, Non-compliance
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start25 Mar 2021
- Primary completion31 Mar 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 388 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of South Carolina, Family Connections
- Responsible party
- Principal investigator, Mark Feinberg, Feinberg, Mark, Ph.D.
- Investigators
- Mark Feinberg, PhD, Principal investigator, Penn State
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04744428
- Sponsor's protocol ID
- APN-RT01
- Acronym
- APN
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2020
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Test of an Innovative, Scalable Support Program for Parents With a Young Child Recently Diagnosed With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT04744428
- Acronym / sponsor ID
- APN / APN-RT01
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 388 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- University of South Carolina, Family Connections
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 9 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To address the dual needs of parents for support in navigating Autistic Spectrum Disorder (ASD) services and maintaining positive family functioning, the investigators propose to test Autism Parent Navigators (APN), an innovative in-home, peer support model for parents with a young child recently diagnosed with ASD.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autism Parent Navigators Intervention | Experimental | Behavioral: Autism Parent NavigatorsAutism Parent Navigators Intervention is a manualized, in-home, peer support model for parents with a young child recently diagnosed with ASD. |
| Peer mentoring | Active comparator | Behavioral: Peer mentoringPeer mentors will offer an equivalent number of in-home or telephone visits for families, providing non-manualized peer support. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Parents of children who have been newly diagnosed with Autism Spectrum Disorder (ASD).
- The child will be age 2-6 years and been diagnosed with ASD in the past four months.
- The child is the first child in the family to be diagnosed with ASD.
- Parents are not already involved in a parent mentoring relationship.
- Parents are currently involved in a couple relationship, including same-sex partners, dating couples, adoptive parents and step-parent families.
Key exclusion criteria (1 listed)
- 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 |
|---|---|---|
| Autism Parent NavigatorsThe Autism Parent Navigator program consists of six sessions delivered to parents in the home, supporting adjustment to ASD, accessing services, and coparenting support. | Behavioural | Autism Parent Navigators Intervention |
| Peer mentoringSix in-home or telephone sessions, depending on family uptake, providing non-manualized general support as usual from parent peer mentors regarding adjustment to ASD. | Behavioural | Peer mentoring |
Primary outcome
Weekly Count of Service Navigation Behaviors
Time frame: 12 month
Engagement with ASD-related Services
Parenting Scale (Arnold)
Time frame: 12 month
Parenting consistency, warmth
CES-Depression
Time frame: 12 month
Parent depression
3 secondary outcomes
Coparenting Relationship Scale (Feinberg, Brown, & Kan, 2012)
Time frame: 12 month
Family Empowerment Scale - FES
Time frame: 12 month
PDD-BI
Time frame: 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Mark Feinberg, PhD principal investigator
Penn State
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autism Parent Navigators and Peer mentoring in people with Autism Spectrum Disorder, run by Penn State University 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 5 inclusion and 1 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 9 Jul 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?
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?
Weekly Count of Service Navigation Behaviors (time frame: 12 month). The study lists 3 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 9 Jul 2026.