Clinical Trials Directory

Trials / Completed

CompletedNCT04909658

The Effect of Acceptance and Commitment Therapy

The Effect of Acceptance and Commitment Therapy for Improving Psychological Well-being in Parents of Individuals With Autism Spectrum Disorder: a Randomized Controlled Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
66 (actual)
Sponsor
S.Anna Rehabilitation Institute · Academic / Other
Sex
All
Age
3 Years – 13 Years
Healthy volunteers
Accepted

Summary

In this randomized control study, investigators will evaluate the effectiveness of the Acceptance and Commitment Therapy (ACT) matrix behavioral protocol compared to Parent Training (PT) programs in improving the psychological well-being of parents of children with Autism Spectrum Disorder (ASD). Twelve parents will be randomly and equitably assigned to two matched groups in which individuals will undergo 24 weekly ACT (experimental group) or conventional PT (control group) protocol meetings

Detailed description

Autism Spectrum Disorder (ASD) is a lifelong neurodevelopmental disorder characterized by core deficits in maladaptive behaviors, communication skills, and self-regulation im-pairments affecting the socio-relational performance of children, but also of their parents. It has widely been demonstrated that raising a child with autism involves chronic challenges consistently associated with high levels of psychological distress. Often parents become isolated from family and friends who may not understand the child's be-havior and disability. The chronic stress experienced by parents of children with ASD also reported to be greater than those experienced by parents of children with other disabilities, such as Down Syndrome, behavioral disorders and Fragile X Syndrome, and also associated with increased divorce rates. It is clear that family members, in this condition, should be supported in the development of new parenting skills useful to achieve targets of intervention while reducing psycho-logical distress. Indeed, reinforcement of parental resources has been considered as potential mediating factors of ASD treatment, which may reduce maladaptive behaviors in children. The present single-blind Randomized Controlled Trial (RCT) is aimed to compare, for the first time, the efficacy of the ACT approach in ASD parents with respect to the PT. Several papers reported the beneficial effects of PT groups as classic support to increase parenting skills in managing the behavior of children with ASD while reducing parental stress. Nevertheless, none has evalu-ated if ACT may be a more powerful approach to threat psychological reaction to the stress of caring for ASD children. The investigators hypothesized that psychological difficulties of parents of children with autism could decrease after a course with goals of transmitting behavioral educational techniques and promoting psychological adjustment through defusion and acceptance strategies. Primary outcome measures and secondary outcome measures will be collected. A pre/post-treatment assessment will be conducted regarding the measurement and change in parental psychological flexibility during the intervention. The primary outcome measures that will be used are the Acceptance and Action Questionnaire II (AAQ-II) to measure the person's psychological flexibility and ability to stay in touch with emotions and the Home Situation Questionnaire (HSQ-ASD) which give objective measures of the perception and influence of children's behavior in the parents' lives. Secondary outcome measures will be the Valued Living Questionnaire (VLQ) to identify areas important to the person, the Mindfulness Attention Awareness Scale (MAAS) which measures an individual's tendency toward intentional awareness, and the Parental Stress Index (PSI) to assess pre- and post-treatment stress levels.

Conditions

Interventions

TypeNameDescription
BEHAVIORALACT MatrixThe ACT protocol group performs exercises to improve the psychological well-being of parents. The matrix is an ACT protocol that is usually presented visually to patients and consists of two intersecting lines that make up four quadrants, which provide a "point of view" on one's psychological actions and experiences. The vertical line is the line of experience, the upper part corresponds to the experience of life linked to the five senses - sight, hearing, taste, smell and touch - (experience of the five senses), the lower part refers to the experiences internal as thoughts and feelings (internal/mental experience). The horizontal line is the behavior line, the left side concerns the actions that perform the function of moving us away from experiences, emotions, unwanted thoughts (experiential avoid-ance), the right side indicates the actions we take to get closer and go towards our values (committed action).
BEHAVIORALPT ProtocolThe PT protocol group received behavioral tasks related to child management. Parent training interventions carried out in groups can be a good solution to modify parent behavior by providing social support and new coping strategies. The intervention includes 24 weekly meetings lasting 90 minutes each. The total intervention is six months.

Timeline

Start date
2018-01-07
Primary completion
2019-12-30
Completion
2020-12-30
First posted
2021-06-02
Last updated
2021-06-02

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT04909658. Inclusion in this directory is not an endorsement.