Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Acceptance and Commitment Therapy (ASDMatrix)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04909658
Recruitment Status : Completed
First Posted : June 2, 2021
Last Update Posted : June 2, 2021
Sponsor:
Collaborator:
Istituto per la Ricerca e l'Innovazione Biomedica
Information provided by (Responsible Party):
S.Anna Rehabilitation Institute

Brief 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

Condition or disease Intervention/treatment Phase
Autism, Infantile Behavioral: ACT Matrix Behavioral: PT Protocol Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A single-blind, randomized controlled study was conducted at our CNR center in Messina. The first stage was based on the recruitment of the parents for the study. Next, the eligible individuals underwent a clinical examination at baseline [T0]. In the third stage, participants were randomly assigned to two groups using a computer-generated randomization code. The following people were all blinded to the group membership of the parents: the physicians (who carried out the clinical baseline assessment [T0] and post-treatment investigation [T1]), the primary researchers, and the data entry assistants. In the fourth stage, participants underwent ACT or PT training therapies. Treatments were carried on by expert therapists who were blinded to all clinical information and also to the aim of the study. At the end of treatment, participants from both groups were given a final evaluation [T1], using the same protocol as at a baseline.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The following people were all blinded to the group membership of the parents: the physicians (who carried out the clinical baseline assessment [T0] and post-treatment investigation [T1]), the primary researchers, and the data entry assistants. In the fourth stage, participants underwent ACT or PT training therapies. Treatments were carried on by expert therapists who were blinded to all clinical information and also to the aim of the study. At the end of treatment, participants from both groups were given a final evaluation [T1], using the same protocol as at a baseline.
Primary Purpose: Supportive Care
Official Title: The Effect of Acceptance and Commitment Therapy for Improving Psychological Well-being in Parents of Individuals With Autism Spectrum Disorder: a Randomized Controlled Trial
Actual Study Start Date : January 7, 2018
Actual Primary Completion Date : December 30, 2019
Actual Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ACT matrix protocol
Parents of childrens with Autism Spectrum Disorders (ASD). The ACT protocol group received exercises to improve the psychological well-being of the parents.
Behavioral: ACT Matrix
The 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).

Active Comparator: PT protocol
Parents of childrens with Autism Spectrum Disorders (ASD).
Behavioral: PT Protocol
The 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.




Primary Outcome Measures :
  1. Acceptance and Action Questionnaire (AAQ-II) [ Time Frame: 6 months after the admission assessment ]
    The AAQ-II is a ten-item test with answers on a scale from 1 (never true) to 7 (always true) to measure the person's psychological flexibility and their ability to stay in touch with emotions. The items focus on the willingness to separate unwanted private events, on the ability to live in the present moment and on the commitment to adopt flexible and valuable actions during the experience of internal negative events.

  2. Home Situation Questionnaire (HSQ-ASD) [ Time Frame: 6 months after the admission assessment ]
    The HSQ-ASD is a caregiver-rated scale designed to assess the severity of disruptive and non-compliant behaviors in children. The score obtained with this scale refers to the parent's perception of their child's behavioral manifestations. Within the scale, data are collected on inflexibility and avoidance manifested by the child. This modified and revised version for ASD consists of 27 elements. Parents are asked to indicate if their children have problems with compliance in these situations and, if so, to rate severity on a Likert scale of 0 to 9, with higher scores indicating greater non-compliance.


Secondary Outcome Measures :
  1. Valued Living Questionnaire (VLQ) [ Time Frame: 6 months after the end of treatment ]

    The VLQ is a questionnaire exploring some areas of life that people consider important such as family relationships; marriage/couple; intimate relationships; friends; social relationships; work; culture/training; leisure/entertainment; spirituality; civic commitment/community life and self-care.

    The questionnaire provides an importance score, in which, for each dimension, the person is asked to rate on a scale from 1 (not at all important) to 10 (extremely important) how important that area of their life is.


  2. Mindful Attention Awareness Scale (MAAS) [ Time Frame: 6 months after the end of treatment ]
    The Mindful Attention Awareness Scale [MAAS] measures individual differences in daily awareness states. Then, respondents rated the 15 elements of the scale on a 7-point Likert-type scale, from 1 (almost always) to 7 (almost never). Higher values indicate higher levels of awareness.

  3. Parental Stress Index/Short Form (PSI/SF) [ Time Frame: 6 months after the end of treatment ]
    The PSI/SF is a self-assessment questionnaire. The administration and compilation of the test take about 10-15 minutes. The hypothesis underlying the test is that parental stress levels are given by the interaction of 3 different factors: 1 characteristic of the children, 2 characteristics of the parent, 3 aspects related to the parental situation.The short form is composed of 36 items, divided into three subscales: (1) Parental Distress (PD), which taps into parental feelings; (2) Parent-Child Dysfunctional Interaction (P-CDI), which focuses on the perception of the child as not responding to parental ex-pectations; (3) Difficult Child (DC), which is centered on some of the characteristics of the child that make it easy or difficult to manage.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

The families were recruited as part of an ongoing research program and tested at our clinical facilities.

Inclusion criteria were based on children characteristics as follows:

  • between 3 and 13 years of age;
  • clinical diagnosis of ASD based on the DSM-5 criteria from a licensed clinical child neuropsychiatrist;
  • DSM-5 severity scores from mild (level 1) to moderate (level 2) in both social communication and restricted interests and repetitive behaviors domains;
  • a verbal and performance Developmental Quotient: Griffiths Mental Development Scales, Extended Revised: 2 to 8 years (GMDS-ER 2-8 Luiz et al. 2006) and Wechsler Intelligence Scale for Children (WISC-IV Wechsler D. 2003) above 70;
  • no hearing, visual, or physical disabilities that would prevent participation in the intervention;
  • not being on psychiatric medication. All children have a previous diagnosis that was further confirmed through the assessment and the consensus of experienced professionals on the research team (i.e., a child neuropsychiatrist and a clinical psychologist).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04909658


Locations
Layout table for location information
Italy
Institute for Biomedical Research and Innovation (IRIB)
Messina, Italy, 98164
Sponsors and Collaborators
S.Anna Rehabilitation Institute
Istituto per la Ricerca e l'Innovazione Biomedica
Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: S.Anna Rehabilitation Institute
ClinicalTrials.gov Identifier: NCT04909658    
Other Study ID Numbers: CNR-AMMCEN 54444/2018
First Posted: June 2, 2021    Key Record Dates
Last Update Posted: June 2, 2021
Last Verified: May 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by S.Anna Rehabilitation Institute:
Autism spectrum disorder
Psychological well-being
Additional relevant MeSH terms:
Layout table for MeSH terms
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders