Autism Spectrum DisorderNCT05300295

Mentorship Program for Individuals With Autism Spectrum Disorder (ASD)

A study testing Mentoring Program in people with Autism Spectrum Disorder, run by University of Minnesota at 1 site 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

The purpose of this pilot project is to evaluate the feasibility of a mentorship program for adolescents with autism spectrum disorder (ASD). Data will be collected from adolescents with ASD and their parents/guardians. Read more about this study

Who is it for?: Ages 14 years and older
Conditions the study is for: Autism Spectrum Disorder
What is being tested?: Mentoring Program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 1 siteUnited States
Study dates: 1 Jan 2019to 31 May 2020
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
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Diagnosis of autism spectrum disorder (ASD)
Age 14-18
Participants in the mentoring program.
Participants must have fluent language and will speak and understand English.
Participants must be able to commit to providing evaluation data.

Who cannot join

Have an intellectual disability (IQ under 70)

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Minnesota
Minneapolis, Minnesota, 55455

Other trials in United States

About this study

Official title: Evaluation of a Mentorship Program for Individuals With Autism Spectrum Disorder (ASD)

Conditions: Autism Spectrum Disorder
Being tested: Mentoring Program
Keywords: Autism, Autism Spectrum Disorder
Medical subject headings: Autism Spectrum Disorder, Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mentoring ProgramBehavioural
Also called Autism Mentorship Program
The Autism Mentorship Program is a psychosocial intervention that pairs adults and adolescents with autism spectrum disorder (ASD) in one-to-one mentoring relationships. AMP involves weekly meetings in an afterschool setting and targets the socio-emotional health and social connectedness of adolescents and adults with ASD.

Study groups in NCT05300295
Study group	Role	What they receive
Mentoring Program	Experimental	The Autism Mentorship Program is a psychosocial intervention that pairs adults and adolescents with autism spectrum disorder (ASD) in one-to-one mentoring relationships. AMP involves weekly meetings in an afterschool setting and targets the socio-emotional health and social connectedness of adolescents and adults with ASD. Receives: Behavioral: Mentoring Program

What is being measured

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

Number of Sessions Attended
Median count of completed session visits
Measured: within 30 days of the intervention end, up to 10 months
Participant Program Satisfaction Scores
Average program satisfaction score; range = 1-5; higher scores are better
Measured: within 30 days of the intervention end, up to 10 months
Mentoring Relationship Quality
Average quality of the mentoring relationship score; range = 1-5; higher scores are better
Measured: within 30 days of the intervention end, up to 10 months
Child Behavior Checklist Scores (Internalizing Subscale)
Parent-completed assessment of child's internalizing behavior; T scores for the internalizing subscale range 0-100 with higher scores being worse
Measured: at pre-intervention (within 30 days of intervention start) and post-intervention (within 30 days of intervention end), up to 10 months
Child Behavior Checklist Scores (Externalizing Subscale)
Parent-completed assessment of child's externalizing behavior; T scores for the externalizing subscale range 0-100 with higher scores being worse
Measured: at pre-intervention (within 30 days of intervention start) and post-intervention (within 30 days of intervention end), up to 10 months
Youth Self-Report Scores (Internalizing Subscale)
Youth self-reported assessment of internalizing behavior; T scores for the internalizing subscale range 0-100 with higher scores being worse
Measured: at pre-intervention (within 30 days of intervention start) and post-intervention (within 30 days of intervention end), up to 10 months
Youth Self-Report Scores (Externalizing Subscale)
Youth self-reported assessment of externalizing behavior; T scores for the externalizing subscale range 0-100 with higher scores being worse
Measured: at pre-intervention (within 30 days of intervention start) and post-intervention (within 30 days of intervention end), up to 10 months
Social Skills Improvement System Scores (Social Competence Scale; Parent-report)
Parent-completed assessment of child's social competence; Standard scores for the social competence subscale range 40-160 with lower scores being worse
Measured: at pre-intervention (within 30 days of intervention start) and post-intervention (within 30 days of intervention end), up to 10 months
Social Skills Improvement System Scores (Problem Behavior Scale; Parent-report)
Parent-completed assessment of child's problem behavior; Standard scores for the problem behavior subscale range 40-160 with higher scores being worse
Measured: at pre-intervention (within 30 days of intervention start) and post-intervention (within 30 days of intervention end), up to 10 months
Social Skills Improvement System Scores (Social Competence Scale; Youth-report)
Youth self-reported assessment of social competence; Standard scores for the social competence subscale range 40-160 with lower scores being worse
Measured: at pre-intervention (within 30 days of intervention start) and post-intervention (within 30 days of intervention end), up to 10 months
Social Skills Improvement System Scores (Problem Behavior Scale; Youth-report)
Youth self-reported assessment of problem behavior; Standard scores for the problem behavior subscale range 40-160 with higher scores being worse
Measured: at pre-intervention (within 30 days of intervention start) and post-intervention (within 30 days of intervention end), up to 10 months

Timeline

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

1 Jan 201931 May 2020

First posted29 Mar 2022
Study start1 Jan 2019
Primary completion31 May 2020
Study completion31 May 2020

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.
More trials run by University of MinnesotaThe sponsor's other registered studies.
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: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05300295
Sponsor's protocol ID: STUDY00003954
Status last verified: Oct 2022
First submitted: 24 Feb 2022
Last updated: 21 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Autism Spectrum Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of a Mentorship Program for Individuals With Autism Spectrum Disorder (ASD)
ClinicalTrials.gov ID: NCT05300295
Acronym / sponsor ID: STUDY00003954
Conditions: Autism Spectrum Disorder
Keywords: Autism, Autism Spectrum Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: University of MinnesotaUniversity, hospital or other
Collaborators: National Institutes of Health (NIH)
Study start: 1 Jan 2019 (actual)
Primary completion: 31 May 2020 (actual)
Study completion: 31 May 2020 (actual)
First posted: 29 Mar 2022 (actual)
Results: Posted 21 Oct 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Mentoring Program	Experimental	Behavioral: Mentoring ProgramThe Autism Mentorship Program is a psychosocial intervention that pairs adults and adolescents with autism spectrum disorder (ASD) in one-to-one mentoring relationships. AMP involves weekly meetings in an afterschool setting and targets the socio-emotional health and social connectedness of adolescents and adults with ASD.

Who may qualify

Ages: 14 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

Diagnosis of autism spectrum disorder (ASD)
Age 14-18
Participants in the mentoring program.
Participants must have fluent language and will speak and understand English.
Participants must be able to commit to providing evaluation data.

Key exclusion criteria (1 listed)

Have an intellectual disability (IQ under 70)

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
Mentoring ProgramAlso: Autism Mentorship ProgramThe Autism Mentorship Program is a psychosocial intervention that pairs adults and adolescents with autism spectrum disorder (ASD) in one-to-one mentoring relationships. AMP involves weekly meetings in an afterschool setting and targets the socio-emotional health and social connectedness of adolescents and adults with ASD.	Behavioural	Mentoring Program

Primary outcome

Number of Sessions Attended
Time frame: within 30 days of the intervention end, up to 10 months
Median count of completed session visits
Participant Program Satisfaction Scores
Time frame: within 30 days of the intervention end, up to 10 months
Average program satisfaction score; range = 1-5; higher scores are better
Mentoring Relationship Quality
Time frame: within 30 days of the intervention end, up to 10 months
Average quality of the mentoring relationship score; range = 1-5; higher scores are better
Child Behavior Checklist Scores (Internalizing Subscale)
Time frame: at pre-intervention (within 30 days of intervention start) and post-intervention (within 30 days of intervention end), up to 10 months
Parent-completed assessment of child's internalizing behavior; T scores for the internalizing subscale range 0-100 with higher scores being worse
Child Behavior Checklist Scores (Externalizing Subscale)
Time frame: at pre-intervention (within 30 days of intervention start) and post-intervention (within 30 days of intervention end), up to 10 months
Parent-completed assessment of child's externalizing behavior; T scores for the externalizing subscale range 0-100 with higher scores being worse
Youth Self-Report Scores (Internalizing Subscale)
Time frame: at pre-intervention (within 30 days of intervention start) and post-intervention (within 30 days of intervention end), up to 10 months
Youth self-reported assessment of internalizing behavior; T scores for the internalizing subscale range 0-100 with higher scores being worse
Youth Self-Report Scores (Externalizing Subscale)
Time frame: at pre-intervention (within 30 days of intervention start) and post-intervention (within 30 days of intervention end), up to 10 months
Youth self-reported assessment of externalizing behavior; T scores for the externalizing subscale range 0-100 with higher scores being worse
Social Skills Improvement System Scores (Social Competence Scale; Parent-report)
Time frame: at pre-intervention (within 30 days of intervention start) and post-intervention (within 30 days of intervention end), up to 10 months
Parent-completed assessment of child's social competence; Standard scores for the social competence subscale range 40-160 with lower scores being worse
Social Skills Improvement System Scores (Problem Behavior Scale; Parent-report)
Time frame: at pre-intervention (within 30 days of intervention start) and post-intervention (within 30 days of intervention end), up to 10 months
Parent-completed assessment of child's problem behavior; Standard scores for the problem behavior subscale range 40-160 with higher scores being worse
Social Skills Improvement System Scores (Social Competence Scale; Youth-report)
Time frame: at pre-intervention (within 30 days of intervention start) and post-intervention (within 30 days of intervention end), up to 10 months
Youth self-reported assessment of social competence; Standard scores for the social competence subscale range 40-160 with lower scores being worse
Social Skills Improvement System Scores (Problem Behavior Scale; Youth-report)
Time frame: at pre-intervention (within 30 days of intervention start) and post-intervention (within 30 days of intervention end), up to 10 months
Youth self-reported assessment of problem behavior; Standard scores for the problem behavior subscale range 40-160 with higher scores being worse

Results and safety

Results posted to the registry on 21 Oct 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mentoring Program	13	13

Primary outcome: Number of Sessions Attended

Time frame: within 30 days of the intervention end, up to 10 months. Median (Standard Deviation). Unit: sessions

Measure	Mentoring Program n = 13
Value	13 (2.58)

Primary outcome: Participant Program Satisfaction Scores

Time frame: within 30 days of the intervention end, up to 10 months. Mean (Standard Deviation). Unit: scores on a scale

Measure	Mentoring Program n = 9
Value	3.56 (1.13)

Primary outcome: Mentoring Relationship Quality

Time frame: within 30 days of the intervention end, up to 10 months. Mean (Standard Deviation). Unit: scores on a scale

Measure	Mentoring Program n = 9
Value	4.12 (0.52)

Primary outcome: Child Behavior Checklist Scores (Internalizing Subscale)

Time frame: at pre-intervention (within 30 days of intervention start) and post-intervention (within 30 days of intervention end), up to 10 months. Mean (Standard Deviation). Unit: T-score

Measure	Mentoring Program n = 13
Pre-intervention	60.92 (9.58)
Post-intervention	63.1 (7.91)

Population analysed: Some participants did not complete this post-intervention assessment.

Adverse events

Time frame: Baseline to study completion, up to 17 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mentoring Program	0 of 13 (0%)	0 of 13 (0%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
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.

Lindsey Weiler, PhD principal investigator

University of Minnesota

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mentoring Program in people with Autism Spectrum Disorder, run by University of Minnesota 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 21 Oct 2022. 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 21 Oct 2022). 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?

Number of Sessions Attended (time frame: within 30 days of the intervention end, up to 10 months). The study lists 11 primary outcomes in all. 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 NCT05300295.

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 21 Oct 2022.