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Insecure Attachment and Psychosocial Functioning in Autistic Adults Are Mediated by Depression and Paranoid Ideation

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Insecure attachment and psychosocial functioning in autistic adults
Sponsored by
Parnassia Groep
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Autism Spectrum Disorder focused on measuring Autism, Attachment, Psychosocial functioning, Adults

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Parnassia Antes

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Assessment of attachment and psychosocial functioning in adults with ASD

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

Beck Depression Inventory-Second Edition-Dutch version-Revised (BDI-2-NL-R)
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.
Green Paranoid Thought Scales (GPTS)
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.
FEEL-E Questionnaire for Emotion Regulation in Adults (FEEL-E)
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).

Full Information

First Posted
July 26, 2023
Last Updated
September 6, 2023
Sponsor
Parnassia Groep
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1. Study Identification

Unique Protocol Identification Number
NCT06030167
Brief Title
Insecure Attachment and Psychosocial Functioning in Autistic Adults Are Mediated by Depression and Paranoid Ideation
Official Title
Insecure Attachment and Psychosocial Functioning in Autistic Adults Are Mediated by Depression and Paranoid Ideation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Parnassia Groep

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The present study examines if depressive symptoms, paranoid ideation, and emotion regulation strategies mediate the relationship between attachment and psychosocial functioning in autistic adults. Within a cross-sectional design, we used mediation analysis to clarify the roles of co-occurring mental conditions as depressive symptoms, paranoid ideation, and (mal)adaptive emotion regulation strategies in mediating the pathway from insecure attachment to psychosocial functioning in autistic adults. Questionaires about attachment, psychosocial functioning, depressive symptoms, paranoid ideation, and emotion regulation were administered to 83 autistic adults (50 males, 33 females).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Autism, Attachment, Psychosocial functioning, Adults

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Assessment of attachment and psychosocial functioning in adults with ASD
Arm Type
Other
Arm Description
Questionaires about attachment, psychosocial functioning, depressive symptoms, paranoid ideation, and emotion regulation were administered to 83 autistic adults (50 males, 33 females).
Intervention Type
Behavioral
Intervention Name(s)
Insecure attachment and psychosocial functioning in autistic adults
Intervention Description
Questionaires about attachment, psychosocial functioning, depressive symptoms, paranoid ideation, and emotion regulation were administered to 83 autistic adults (50 males, 33 females).
Primary Outcome Measure Information:
Title
Experiences in Close Relationships - Revised questionnaire (ECR-r)
Description
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.
Time Frame
15 minutes
Title
World Health Organisation Disability Assessment Schedule 2.0 (WHODAS 2.0)
Description
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).
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Beck Depression Inventory-Second Edition-Dutch version-Revised (BDI-2-NL-R)
Description
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.
Time Frame
10 minutes
Title
Green Paranoid Thought Scales (GPTS)
Description
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.
Time Frame
15 minutes
Title
FEEL-E Questionnaire for Emotion Regulation in Adults (FEEL-E)
Description
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).
Time Frame
20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Vuijk, Dr.
Organizational Affiliation
Parnassia Antes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parnassia Antes
City
Rotterdam
State/Province
South-Holland
ZIP/Postal Code
3083AK
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

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Insecure Attachment and Psychosocial Functioning in Autistic Adults Are Mediated by Depression and Paranoid Ideation

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