Autism, InfantileASDMatrixNCT04909658
The Effect of Acceptance and Commitment Therapy
A study testing ACT Matrix and PT Protocol in people with Autism, Infantile, run by S.Anna Rehabilitation Institute at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 3 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism, Infantile
- What is being tested?
- ACT Matrix and PT Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jan 2018to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
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).
Trial locations and contacts
1 site in 1 country.
Italy1 site
Institute for Biomedical Research and Innovation (IRIB)
Messina, 98164
About this study
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
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
Read the 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
- Autism, Infantile
- Being tested
- ACT Matrix, PT Protocol
- Keywords
- Autism spectrum disorder, Psychological well-being
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT MatrixBehavioural
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).
PT ProtocolBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ACT matrix protocol | Experimental | Parents of childrens with Autism Spectrum Disorders (ASD). The ACT protocol group received exercises to improve the psychological well-being of the parents. Receives: Behavioral: ACT Matrix |
| PT protocol | Active comparator | Parents of childrens with Autism Spectrum Disorders (ASD). Receives: Behavioral: PT Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance and Action Questionnaire (AAQ-II)
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.
Measured: 6 months after the admission assessment
Home Situation Questionnaire (HSQ-ASD)
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.
Measured: 6 months after the admission assessment
Secondary outcomes (3)
Valued Living Questionnaire (VLQ)
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.
Measured: 6 months after the end of treatment
Mindful Attention Awareness Scale (MAAS)
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.
Measured: 6 months after the end of treatment
Parental Stress Index/Short Form (PSI/SF)
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.
Measured: 6 months after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start7 Jan 2018
- Primary completion30 Dec 2019
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Autism, InfantileStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- S.Anna Rehabilitation Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto per la Ricerca e l'Innovazione Biomedica
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04909658
- Sponsor's protocol ID
- CNR-AMMCEN 54444/2018
- Acronym
- ASDMatrix
- Status last verified
- May 2021
- First submitted
- 22 Apr 2021
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bearss K, Johnson C, Smith T, Lecavalier L, Swiezy N, Aman M, McAdam DB, Butter E, Stillitano C, Minshawi N, Sukhodolsky DG, Mruzek DW, Turner K, Neal T, Hallett V, Mulick JA, Green B, Handen B, Deng Y, Dziura J, Scahill L. Effect of parent training vs parent education on behavioral problems in children with autism spectrum disorder: a randomized clinical trial. JAMA. 2015 Apr 21;313(15):1524-33. doi: 10.1001/jama.2015.3150.
PubMed 25898050Bond FW, Bunce D. Mediators of change in emotion-focused and problem-focused worksite stress management interventions. J Occup Health Psychol. 2000 Jan;5(1):156-63. doi: 10.1037//1076-8998.5.1.156.
PubMed 10658893Abbeduto L, Seltzer MM, Shattuck P, Krauss MW, Orsmond G, Murphy MM. Psychological well-being and coping in mothers of youths with autism, Down syndrome, or fragile X syndrome. Am J Ment Retard. 2004 May;109(3):237-54. doi: 10.1352/0895-8017(2004)1092.0.CO;2.
PubMed 15072518
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04909658
- Acronym / sponsor ID
- ASDMatrix / CNR-AMMCEN 54444/2018
- Conditions
- Autism, Infantile
- Keywords
- Autism spectrum disorder, Psychological well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- S.Anna Rehabilitation InstituteUniversity, hospital or other
- Collaborators
- Istituto per la Ricerca e l'Innovazione Biomedica
- Study start
- 7 Jan 2018 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 2 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| ACT matrix protocol | Experimental | Behavioral: ACT MatrixParents of childrens with Autism Spectrum Disorders (ASD). The ACT protocol group received exercises to improve the psychological well-being of the parents. |
| PT protocol | Active comparator | Behavioral: PT ProtocolParents of childrens with Autism Spectrum Disorders (ASD). |
Who may qualify
- Ages
- 3 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT 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). | Behavioural | ACT matrix protocol |
| PT 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. | Behavioural | PT protocol |
Primary outcome
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.
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.
3 secondary outcomes
Valued Living Questionnaire (VLQ)
Time frame: 6 months after the end of treatment
Mindful Attention Awareness Scale (MAAS)
Time frame: 6 months after the end of treatment
Parental Stress Index/Short Form (PSI/SF)
Time frame: 6 months after the end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Background: PubMed 25898050Bearss K, Johnson C, Smith T, Lecavalier L, Swiezy N, Aman M, McAdam DB, Butter E, Stillitano C, Minshawi N, Sukhodolsky DG, Mruzek DW, Turner K, Neal T, Hallett V, Mulick JA, Green B, Handen B, Deng Y, Dziura J, Scahill L. Effect of parent training vs parent education on behavioral problems in children with autism spectrum disorder: a randomized clinical trial. JAMA. 2015 Apr 21;313(15):1524-33. doi: 10.1001/jama.2015.3150.
- Background: PubMed 10658893Bond FW, Bunce D. Mediators of change in emotion-focused and problem-focused worksite stress management interventions. J Occup Health Psychol. 2000 Jan;5(1):156-63. doi: 10.1037//1076-8998.5.1.156.
- Results publication: PubMed 15072518Abbeduto L, Seltzer MM, Shattuck P, Krauss MW, Orsmond G, Murphy MM. Psychological well-being and coping in mothers of youths with autism, Down syndrome, or fragile X syndrome. Am J Ment Retard. 2004 May;109(3):237-54. doi: 10.1352/0895-8017(2004)1092.0.CO;2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT Matrix and PT Protocol in people with Autism, Infantile, run by S.Anna Rehabilitation Institute at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptance and Action Questionnaire (AAQ-II) (time frame: 6 months after the admission assessment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04909658, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2021.