- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06030167
Insecure Attachment and Psychosocial Functioning in Autistic Adults Are Mediated by Depression and Paranoid Ideation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
South-Holland
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Rotterdam, South-Holland, Netherlands, 3083AK
- Parnassia Antes
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- a primary clinical diagnosis of DSM-5 ASD (APA, 2013)
- age ≥ 18 years
- at least eight years of education.
Exclusion Criteria:
- intellectual disability (IQ ≤ 80)
- presence of current suicidal ideation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Assessment of attachment and psychosocial functioning in adults with ASD
Questionaires about attachment, psychosocial functioning, depressive symptoms, paranoid ideation, and emotion regulation were administered to 83 autistic adults (50 males, 33 females).
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Questionaires about attachment, psychosocial functioning, depressive symptoms, paranoid ideation, and emotion regulation were administered to 83 autistic adults (50 males, 33 females).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Experiences in Close Relationships - Revised questionnaire (ECR-r)
Time Frame: 15 minutes
|
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)
Time Frame: 15 minutes
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Beck Depression Inventory-Second Edition-Dutch version-Revised (BDI-2-NL-R)
Time Frame: 10 minutes
|
Measuring self-rated levels of depression in 83 autistic adults. Welch's two sample t-test was used to compare the BDI-2-NL-R data between the participants and (non-)clinical controls drawn from the manuals of the used measure. The BDI-2-NL-R is a 21-item self report assessing the presence and severity of depressive symptoms, according to the Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV; American Psychiatric Association, 1994). The BDI-2-NL-R is also compatible with DSM-5 depressive disorder (APA, 2013; 2022). The items are scored on a 4-point scale with a total score ranging from 0 to 63 indicating minimal (0-13), mild (14-19), moderate (20-28), or severe (29-63) depression. |
10 minutes
|
|
Green Paranoid Thought Scales (GPTS)
Time Frame: 15 minutes
|
Measuring self-rated levels of paranodi thoughts in 83 autistic adults. Welch's two sample t-test was used to compare the GPTS data between the participants and (non-)clinical controls drawn from the manuals of the used measure. The GPTS is a 32-item self-report assessing 16 ideas of persecution and 16 ideas of social reference on a 5-point scale, with a total score ranging from 32 to 160, with higher scores indicating higher levels of paranoid ideation. |
15 minutes
|
|
FEEL-E Questionnaire for Emotion Regulation in Adults (FEEL-E)
Time Frame: 20 minutes
|
Measuring self-rated levels of emotion regulation in 83 autistic adults. Welch's two sample t-test was used to compare the GPTS data between the participants and (non-)clinical controls drawn from the manuals of the used measure. The FEEL-E is a 72-item self-report questionnaire assessing emotion regulation strategies, consisting of six adaptive (problem-oriented action, acceptance, cognitive problem-solving, reappraisal, evoking positive feelings, forgetting) and six maladaptive (withdrawal, self-blame, resignation, rumination, negative thinking, other-blame) strategies. The items are scored on a 5-point scale with a total score ranging from 36 to 180 for each strategy (T-score < 40: below average use of strategy; T-score 40-60: average use of strategy; T-score > 60: above average use of strategy). |
20 minutes
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Richard Vuijk, Dr., Parnassia Antes
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CWO-27-004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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