Clinical trial NCT06502054: Parenting with an Autism Spectrum Disorder
Official title: Being a Parent with an Autism Spectrum Disorder: Strengths, Challenges and Adaptation of a Mentalization-based Parenting Program
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Autism Spectrum Disorder
Keywords: Parenthood
Autism Spectrum Disorder
Preschool children
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2024-07-15
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents who fulfill the main diagnosis of ASD, who are ≥ 18 years old and have a child aged 0 to 6 years.

Brief summary: In many individuals, Autism Spectrum Disorder (ASD) is recognized and diagnosed late in adolescence or even in adulthood, despite the presence of long-standing impairments and distress. One area that has received little attention so far is research and interventions in clinical practice that relate to the experienced realities of parenthood for autistic adults or offer support in this context. The few existing research findings in this field suggest that parents with ASD might face specific challenges. At the same time, there is a lack of empirical research on the experiences autistic adults have with parenthood, whether they perceive a need for specific support services, and, if so, what those services should look like. To fill this research gap, this study aims to examine the mental health, needs, and strengths of parents with ASD. Particular focus will be given to parental stress and difficulties in the areas of mentalization and emotion regulation, which can increase the risk of psychological comorbidities. Using a mixed-methods approach, the study will investigate to what extent an already established parenting program or an adaptation thereof might be suitable to address the specific requirements of autistic parents and enhance their parenting skills.


Eligibility criteria: In- and exclusion criteria for the study population:

Inclusion Criteria:

* Parents who fulfill the main diagnosis of ASD, including atypical autism (ICD-10: F84.1) and Asperger syndrome (ICD-10: F84.5)
* Age ≥ 18 years
* Have a child aged 0 to 6 years

Exclusion Criteria:

* Below-average general cognitive ability (according to clinical impression)
* Lack of German language skills
* Severe visual or hearing impairment (uncorrected)
* Serious neurological and psychiatric illnesses (e.g., epilepsy, psychoses)
* Acute suicidal tendencies (according to clinical findings)

Eligibility Criteria for the Control Group

Inclusion Criteria:

* Parents without a lifetime main diagnosis of a psychiatric illness (ICD-10-GM-2016: F10 - F69)
* Age ≥ 18 years
* Have a child aged 0 to 6 years
* Matched to the study group in terms of age and gender

Exclusion Criteria:

* Above-mentioned psychiatric diagnoses
* Below-average general cognitive ability
* Lack of German language skills
* Severe impairment of vision or hearing (not corrected)

Primary outcomes:
measure: Mentalization
timeFrame: Baseline assessment
Secondary outcomes:
measure: Autistic Traits
timeFrame: Baseline assessment
measure: Parental Quality of Life
timeFrame: Baseline assessment
measure: Parental mental health
timeFrame: Baseline assessment
measure: Children mental health
timeFrame: Baseline assessment
Other outcomes:
measure: Emotion regulation
timeFrame: Baseline assessment
measure: Parental stress
timeFrame: Baseline assessment
measure: Self-efficacy in parenting
timeFrame: Baseline assessment
measure: Mentalization II
timeFrame: Baseline assessment
measure: Mentalization III
timeFrame: Baseline assessment
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
References: