Improving psychological distress in parents of children with autism using a new behavioural treatment called Acceptance and Commitment Therapy
| ISRCTN | ISRCTN17497289 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17497289 |
- Submission date
- 05/05/2021
- Registration date
- 17/05/2021
- Last edited
- 12/04/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Acceptance and Commitment Therapy (ACT) can be useful for improving the psychological well-being of parents of children with Autism Spectrum Disorders (ASD), but until now there is no evidence on the effectiveness of the ACT model with respect to other well-known behavioral treatments. The aim of this study is to assess the effectiveness of ACT compared to the Parent Training (PT) program for parents of children with ASD.
Who can participate?
Parents of children with ASD
What does the study involve?
Parents are randomly allocated to attend 24 weekly meetings lasting 90 minutes each following the ACT protocol or conventional PT. The intervention lasts about 6 months.
What are the possible benefits and risks of participating?
The parent training program may promote psychological positive parenting and reduce the behavioral risk of children. No risks are foreseen.
Where is the study run from?
Research unit in accordance with the Sicilian Region health system (Italy)
When is the study starting and how long is it expected to run for?
December 2017 to December 2020
Who is funding the study?
Sicilian Region (Italy)
Who is the main contact?
Giovanni Pioggia
Giovanni.pioggia@cnr.it
Contact information
Scientific
Institute for Biomedical Research and Innovation (IRIB), National Research Council of Italy (CNR)
Messina
98164
Italy
 ORCID ID |
0000-0002-8089-7449 |
|---|---|
| Phone | +39 (0)3203390892 |
| giovanni.pioggia@cnr.it |
Study information
| Study design | Single-center interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | The effect of Acceptance and Commitment Therapy for improving psychological well-being in parents of individuals with autism spectrum disorders: a randomized controlled trial |
| Study acronym | ACT-pA |
| Study objectives | To evaluate the effectiveness of the Acceptance and Commitment Therapy (ACT) approach with respect to parental training in reducing psychological distress and improving well-being in parents of autism spectrum disorder (ASD) children. |
| Ethics approval(s) | Approved 02/08/2018, National Research Council (Piazzale Aldo Moro, 7, 00185, Rome, Italy; +39 (0)6 4993/7900; cnr.ethics@cnr.it), ref: 0054444/2018 |
| Health condition(s) or problem(s) studied | Psychological distress in parents of children with autism |
| Intervention | Parent pairs are randomly assigned to the experimental group (ACT matrix protocol) or to the control group (Parent Training (PT) protocol) using a computer-generated randomization code. The interventions consist of 24 weekly meetings lasting 90 minutes each. The total intervention lasts about 6 months. The experimental group undergo the Acceptance and Commitment Therapy (ACT) protocol. This 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 avoidance), the right side indicates the actions we take to get closer and go towards our values (committed action). The control group undergo the Parental Training (PT) protocol. This consists of a training program for parents to teach behavioral management skills for children. The purpose of a parent training program is to promote positive parenting and reduce the behavioral risk of children. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Psychological flexibility measured using the Acceptance and Action Questionnaire II (AAQ-II) at baseline and 6 months 2. Perception and influence of children's behavior on parent's life measured using Home Situation Questionnaire (HSQ-ASD) at baseline and 6 months |
| Secondary outcome measures | 1. Participants' extent of valued living measured using the Valued Living Questionnaire (VLQ) at baseline and 6 months 2. Tendency of an individual to intentional awareness measured using the Mindfulness Attention Awareness Scale (MAAS) at baseline and 6 months 3. Stress level measured using the Parental Stress Index (PSI) at baseline and 6 months |
| Overall study start date | 01/12/2017 |
| Completion date | 01/12/2020 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 66 |
| Total final enrolment | 20 |
| Key inclusion criteria | Parent of child: 1. Between 4 and 10 years of age 2. Clinical diagnosis of ASD based on the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria from a licensed clinical child neuropsychiatric 3. DSM-5 severity scores from mild (level 1) to moderate (level 2) in both social communication and restricted interests and repetitive behaviors domains 4. A verbal and performance Griffiths Mental Development Scales, Extended Revised: 2 to 8 years (GMDS-ER 2-8) and Wechsler Intelligence Scale for Children (WISC-IV) above 70 5. No hearing, visual, or physical disabilities that would prevent participation in the intervention 6. Not being on psychiatric medication |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/09/2019 |
| Date of final enrolment | 01/09/2020 |
Locations
Countries of recruitment
- Italy
Study participating centre
Messina
98164
Italy
Sponsor information
Research council
Aldo Moro Square
Rome
00185
Italy
| Phone | +39 (0)649937900 |
|---|---|
| cnr.ethics@cnr.it | |
| Website | https://www.cnr.it/en/ethical-clearance |
"ROR" |
https://ror.org/04zaypm56 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/07/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Giovanni Pioggia (Giovanni.pioggia@cnr.it). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 30/06/2021 | 12/04/2022 | Yes | No |
Editorial Notes
12/04/2022: Publication reference added.
05/05/2021: Trial's existence confirmed by the National Research Council (Italy).
