Investigating the impact of group-based training using acceptance and commitment therapy on self-esteem and perceived stress in mothers of children with attention deficit/hyperactivity disorder.
Investigating the impact of group-based training using acceptance and commitment therapy on self-esteem and perceived stress in mothers of children with attention deficit/hyperactivity disorder.
Design
clinical trial with intervention and control groups (25 individuals in each group), parallel, not blinded, block randomization
Settings and conduct
The study will be conducted at the Afagh Center for Learning Disorders. Once informed consent is obtained, 25 participants will be randomly assigned to either the intervention or control group. The intervention group will participate in eight group training sessions based on Acceptance and Commitment Therapy, while the control group will not receive any intervention during the study. All participants will complete a pre-test questionnaire, and after the protocol has been implemented and three months of intervention have passed, post-test and follow-up questionnaires will also be completed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having a child aged 7 to 12 years with attention deficit/hyperactivity disorder, the education level higher than diploma, informed consent to participate in the study, not having any known psychiatric disorder, and not having any disabilities or physical and mental illness that would prevent participation.
Exclusion criteria: Receiving psychotropic medications in the past three months, participating in psychological treatment and training courses in the past three months
Intervention groups
Intervention group (25 individuals) will participate in 8 sessions (one 90-minute session per week) of group training based on acceptance and commitment therapy while the control group (25 individuals) will not receive any intervention.
Main outcome variables
Self-esteem; Perceived stress of mothers with ADHD children
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220610055124N1
Registration date:2023-05-29, 1402/03/08
Registration timing:prospective
Last update:2023-05-29, 1402/03/08
Update count:0
Registration date
2023-05-29, 1402/03/08
Registrant information
Name
Mahya Mojahedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3242 3335
Email address
mojahedi.m@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2023-10-23, 1402/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the impact of group-based training using acceptance and commitment therapy on self-esteem and perceived stress in mothers of children with attention deficit/hyperactivity disorder.
Public title
The impact of group-based training using acceptance and commitment therapy on self-esteem and perceived stress.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having a child aged 7 to 12 years with attention deficit/hyperactivity disorder
The education level higher than diploma
Informed consent to participate in the study
Not having any known psychiatric disorder
Not having any disabilities or physical and mental illness that would prevent participation.
Exclusion criteria:
Receiving psychotropic medications in the past three months
Participating in psychological treatment and training courses in the past three months
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be selected through convenience sampling and then allocated to two groups, intervention (A) and control (B), using block randomization. For this purpose, blocks of four will be created from the combination of AABB, and blocks will be randomly selected until the sample size is complete.
Mersenne Twister will be used as the randomization tool.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Science
Street address
Birjand University of Medical Sciences - Ayatollah Ghaffari Street
Attention-deficit hyperactivity disorder, combined type
Primary outcomes
1
Description
The average score that the participants will obtain from the Eysenck self-esteem questionnaire.
Timepoint
Before and immediately after and 3 months after intervention
Method of measurement
Eysenck Self Esteem Questionnaire
2
Description
The average score that the participants will obtain from the Perceived Stress Scale.
Timepoint
Before and immediately after and 3 months after intervention
Method of measurement
Perceived Stress Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 25 participants will participate in eight 90-minute group sessions (one session per week) based on acceptance and commitment therapy. The content of the sessions is as follows: * Session one: Pre-test implementation (Eysenck self-esteem questionnaire and perceived stress scale), introducing the research topic to group members, an introduction to attention deficit/hyperactivity disorder and its effects on parents and family members, and the impact of psychological treatments on it. * Session two: Examining the external and internal world in acceptance and commitment-based therapy/challenging control strategies. * Session three: Identifying personal values, clarifying values, specifying goals, specifying actions and obstacles/extracting the experience that control is a problem. * Session four: Reviewing values and deepening previous concepts/defusing from depressing thoughts and feelings. * Session five: Understanding fusion and defusion and doing exercises for defusion/measuring participants' ability to defusion. * Session six: Understanding self-conceptualized fusion and teaching how to defuse from it. * Session seven: Mindfulness and emphasis on being in the present moment/importance of values. * Session eight: Reviewing life story and committing to action/reflecting on the progress made and the ongoing goals of the participants, post-test implementation (Eysenck self-esteem questionnaire and perceived stress scale). After three months, the participants will be re-evaluated using the Eysenck self-esteem questionnaire and perceived stress scale in the follow-up phase.
Category
Treatment - Other
2
Description
Control group: At the beginning of the study, these participants (25 individuals) will participate in the pre-test (Eysenck self-esteem questionnaire and perceived stress scale) and will not receive any intervention during the group-based acceptance and commitment therapy phase. At the end of the group-based therapy for the intervention group, these individuals will also participate in the post-test (Eysenck Self-Esteem Questionnaire and Perceived Stress Scale). After three months, the participants will be re-evaluated using the Eysenck self-esteem questionnaire and perceived stress scale in the follow-up phase.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Afagh Learning Disorders Center
Full name of responsible person
Marziyeh Baetminan
Street address
Afagh Learning Disorders Center- 17 Shahrivar St.
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۶۸۳۳۳۴۱
Phone
+98 56 3223 8835
Fax
Email
M.Baetminan@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Reza Miri Moghadam
Street address
Birjand University of Medical Sciences - Ayatollah Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5000
Fax
+98 56 3204 8321
Email
miri_moh2516@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mahya Mojahedi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Department of Psychiatry, Imam Reza Hospital, Taleghani St., Birjand, Iran
City
Birjand
Province
South Khorasan
Postal code
9717855659
Phone
+98 56 3242 3335
Email
mojahedi.m@bums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mahya Mojahedi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Department of Psychiatry, Imam Reza Hospital, Taleghani St., Birjand, Iran City
City
Birjand
Province
South Khorasan
Postal code
9717855659
Phone
+98 56 3242 3335
Email
mojahedi.m@bums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mahya Mojahedi
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Department of Psychiatry, Imam Reza Hospital, Taleghani St., Birjand, Iran
City
Birjand
Province
South Khorasan
Postal code
9717855659
Phone
+98 56 3242 3335
Email
mojahedi.m@bums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available