NCT06924008

Brief Summary

The aim of this study is to develop a methodological intervention for adults with autism that will help them reduce problems arising from eye contact.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
6mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress63%
Jul 2025Nov 2026

First Submitted

Initial submission to the registry

March 28, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 11, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

July 7, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2026

Last Updated

April 11, 2025

Status Verified

April 1, 2025

Enrollment Period

12 months

First QC Date

March 28, 2025

Last Update Submit

April 4, 2025

Conditions

Keywords

InterventionEye contactAutism Spectrum DisorderASDIntervention Mapping

Outcome Measures

Primary Outcomes (1)

  • Developing an intervention using the Intervention Mapping method.

    An effective intervention for adults with autism that reduces their difficulty with eye contact problems, with use of Intervention Mapping. The Intervention Mapping protocol consists of six steps, with a number of tasks described for each step. These steps are carried out within focus groups, with two months of time set aside for each step. The six steps of the Intervention Mapping process are: Step 1: Needs assessment Step 2: Change objectives Step 3: Theoretical methods and practical techniques Step 4: Programme design and production Step 5: Program Adoption and Implementation Step 6: Evaluation

    Up to 12 months.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of adults with autism, caregivers of adults with autism, and healthcare providers (psychiatrists, psychologists and nursing specialists in psychiatry).

You may qualify if:

  • Adults classified with autism, determined according to an internationally recognized classification system.
  • Outpatient treatment within a specialized autism center in the Netherlands.
  • Able to understand the topics to be discussed.
  • Motivation to participate in research.

You may not qualify if:

  • No good command of the Dutch language.
  • Use of alcohol and/or recreational drugs during the study.
  • Mentally too unstable to participate in the study.
  • Familiarity with treatment in the VGZ.
  • Adults without DSM classification.
  • Living in the Netherlands.
  • Able to understand the topics to be discussed.
  • Motivation to participate in research.
  • No good command of the Dutch language.
  • Use of alcohol and/or recreational drugs during the study.
  • Practicing psychiatrist, clinical psychologist or nurse specialist at an autism expertise center in the Netherlands.
  • Living in the Netherlands.
  • Motivation to participate in research.
  • \- No good command of the Dutch language.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dimence Groep

Deventer, Overijssel, 7416 SB, Netherlands

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Nynke Boonstra, Professor

    UMC Utrecht

    STUDY CHAIR

Central Study Contacts

Nynke Boonstra, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
6 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

March 28, 2025

First Posted

April 11, 2025

Study Start

July 7, 2025

Primary Completion (Estimated)

July 3, 2026

Study Completion (Estimated)

November 2, 2026

Last Updated

April 11, 2025

Record last verified: 2025-04

Locations