The Effect of Acceptance and Commitment Therapy

NCT04909658 | Completed DMC

• 1 other identifier: CNR-AMMCEN 54444/2018
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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

Conditions

Autism, Infantile

Keywords

Autism spectrum disorder; Psychological well-being

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6 months after the admission assessment

Secondary Outcomes (3)

• Valued Living Questionnaire (VLQ)

  6 months after the end of treatment

• Mindful Attention Awareness Scale (MAAS)

  6 months after the end of treatment

• Parental Stress Index/Short Form (PSI/SF)

  6 months after the end of treatment

Study Arms (2)

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.

Behavioral: ACT Matrix

PT protocol

ACTIVE COMPARATOR

Parents of childrens with Autism Spectrum Disorders (ASD).

Behavioral: PT Protocol

Interventions

ACT Matrix BEHAVIORAL

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).

ACT matrix protocol

PT Protocol BEHAVIORAL

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.

PT protocol

Eligibility Criteria

• Age: 3 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

Sponsors & Collaborators

• S.Anna Rehabilitation Institute: lead
• Istituto per la Ricerca e l'Innovazione Biomedica: collaborator

Study Sites (1)

Institute for Biomedical Research and Innovation (IRIB)

Messina, 98164, Italy

Location

Related Publications (3)

• 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.

  PMID: 25898050 BACKGROUND

• Bond 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.

  PMID: 10658893 BACKGROUND

• Abbeduto 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.

  PMID: 15072518 RESULT

MeSH Terms

Conditions

Autistic Disorder; Autism Spectrum Disorder; Psychological Well-Being

Interventions

CAMFTP protocol

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: June 2, 2021
• Study Start: January 7, 2018
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2020
• Last Updated: June 2, 2021

Record last verified: 2021-05

Locations

IT (1)