NCT06030167

Brief Summary

The present study examines if depressive symptoms, paranoid ideation, and emotion regulation strategies mediate the relationship between attachment and psychosocial functioning in autistic adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 8, 2023

Completed
Last Updated

September 8, 2023

Status Verified

September 1, 2023

Enrollment Period

1.7 years

First QC Date

July 26, 2023

Last Update Submit

September 6, 2023

Conditions

Keywords

AutismAttachmentPsychosocial functioningAdults

Outcome Measures

Primary Outcomes (2)

  • Experiences in Close Relationships - Revised questionnaire (ECR-r)

    Measuring self-rated levels of insecure attachment in 83 adults with autism spectrum disorder. Welch's two sample t-test was used to compare the ECR-r data between the participants and (non-)clinical controls drawn from the manuals of the used measure. The ECR-R is a 36-item measure designed to assess individual differences with respect to attachment-related anxiety (i.e., the extent to which people are insecure versus secure about the availability and responsiveness of romantic partners; items 1 to 18) and attachment-related avoidance (i.e., the extent to which people are uncomfortable being close to others versus secure depending on others; items 19 to 36). The items are scored on a 7-point scale, with higher scores (\>= 4) indicating more insecure attachment. A mean score (ranging from 0 to 7) is calculated for both attachment styles.

    15 minutes

  • World Health Organisation Disability Assessment Schedule 2.0 (WHODAS 2.0)

    Measuring self-rated levels of psycho-social functioning in 83 autistic adults. Welch's two sample t-test was used to compare the WHODAS 2.0 data between the participants and (non-)clinical controls drawn from the manuals of the used measure. WHODAS 2.0 is a generic assessment self-report for health and disability in adults, consisting of 36 items on a 5-point scale (none, mild, moderate, severe, and extreme) covering six domains: cognitions, mobility, self-care, interaction, life activities, and participation in society. WHODAS 2.0 asks the individual to rate how much difficulty they have had in specific areas of functioning during the past 30 days. WHODAS 2.0 produces standardized disability levels and profiles by summing six domain scores and converting the summary score into a metric range from 0 (= no disability) to 100 (= full disability).

    15 minutes

Secondary Outcomes (3)

  • Beck Depression Inventory-Second Edition-Dutch version-Revised (BDI-2-NL-R)

    10 minutes

  • Green Paranoid Thought Scales (GPTS)

    15 minutes

  • FEEL-E Questionnaire for Emotion Regulation in Adults (FEEL-E)

    20 minutes

Study Arms (1)

Assessment of attachment and psychosocial functioning in adults with ASD

OTHER

Questionaires about attachment, psychosocial functioning, depressive symptoms, paranoid ideation, and emotion regulation were administered to 83 autistic adults (50 males, 33 females).

Behavioral: Insecure attachment and psychosocial functioning in autistic adults

Interventions

Questionaires about attachment, psychosocial functioning, depressive symptoms, paranoid ideation, and emotion regulation were administered to 83 autistic adults (50 males, 33 females).

Assessment of attachment and psychosocial functioning in adults with ASD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a primary clinical diagnosis of DSM-5 ASD (APA, 2013)
  • age ≥ 18 years
  • at least eight years of education.

You may not qualify if:

  • intellectual disability (IQ ≤ 80)
  • presence of current suicidal ideation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parnassia Antes

Rotterdam, South Holland, 3083AK, Netherlands

Location

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic Disorder

Interventions

Psychosocial Functioning

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Psychology, DevelopmentalPsychologyBehavioral SciencesBehavioral Disciplines and ActivitiesHealth StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Richard Vuijk, Dr.

    Parnassia Antes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 26, 2023

First Posted

September 8, 2023

Study Start

October 1, 2017

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

September 8, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations