Protocol summary

Summary
The aim of this study is to determine the effectiveness of cognitive-behavioral counseling on sexual satisfaction of mothers with autistic children. This study is a randomized clinical trial, single-blind and without a placebo and is conducted on the mothers of children with autism in a control and an intervention group. The sample size has been considered 15 each group and 30 subjects in total. The criteria for inclusion are as follow: participants must be mothers of ages 25 to 45, must not be pregnant, must not be using psychotropic or psychiatric drugs, must not suffer from any addiction, must have completed at least the fifth grade of elementary school, must have a good command of Farsi, must be living with her husband, must not have any psychiatric history of depression requiring treatment, must have a child over 5 years old with severe autism (confirmed by a psychotherapist of a credible academic center), must not have another child suffering from autism or any other disease, must not have sexual dissatisfaction prior to the birth of child with autism. Criteria for exclusion from the study are as follow: mothers who have complete sexual satisfaction on the basis of Sexual Satisfaction Scale designed by Linda Berg and Cresy, Severe psychiatric disorders or suicidal thoughts, a history of psychosis or suicide, attending relaxation or yoga classes and the like, failure to attend two or more of counseling sessions, lack of consent to participate in research. Members of both groups complete Linda Berg’s Sexual Satisfaction Scale designed by Linda Berg and Cresy and the demographic before the intervention. The intervention group receives individual counseling with cognitive behavioral approach over eight 1.5 hour sessions at Qom province autism schools. For the control group, A two-hour training program will be held. Immediately and one month after the counseling sessions, both groups answer a post-test. Sexual satisfaction score will then be compared between the intervention and control groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016111130830N1
Registration date: 2017-01-02, 1395/10/13
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-01-02, 1395/10/13
Registrant information
Name
Leila Arbhl
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3826 1081
Email address
farzanehgolboni@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2017-01-04, 1395/10/15
Expected recruitment end date
2017-04-18, 1396/01/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The survey of cognitive-behavioral counseling effect on mothers sexual satisfaction who have children with autism
Public title
The counseling effect on mothers sexual satisfaction who have children with autism
Purpose
Prevention
Inclusion/Exclusion criteria
The criteria for inclusion are as follow: participants must be mothers of ages 25 to 45, must not be pregnant, must not be using psychotropic or psychiatric drugs, must not suffer from any addiction, must have completed at least the fifth grade of elementary school, must have a good command of Farsi, must be living with her husband, must not have any psychiatric history of depression requiring treatment, must have a child over 5 years old with severe autism (confirmed by a psychotherapist of a credible academic center), must not have another child suffering from autism or any other disease, must not have sexual dissatisfaction prior to the birth of child with autism. Criteria for exclusion from the study are as follow: mothers who have complete sexual satisfaction on the basis of Sexual Satisfaction Scale designed by Linda Berg and Cresy, Severe psychiatric disorders or suicidal thoughts, a history of psychosis or suicide, attending relaxation or yoga classes and the like, failure to attend two or more of counseling sessions, lack of consent to participate in research.
Age
From 25 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Kermanshah University of Medical Sciences
Street address
Kermanshah, Shahid Beheshti Blvd, Building No. 2, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
6714673159
Approval date
2016-12-14, 1395/09/24
Ethics committee reference number
IR.KUMS.REC.1395.536

Health conditions studied

1

Description of health condition studied
Sexual Satisfaction
ICD-10 code
Z70.0
ICD-10 code description
Counselling related to sexual attitude

Primary outcomes

1

Description
Sexual Satisfaction
Timepoint
Before intervention, Immediately after the intervention And a month later
Method of measurement
Sexual satisfaction questionnaire of Linda berg & Cresy

Secondary outcomes

empty

Intervention groups

1

Description
individual counseling with cognitive behavioral approach over eight 1.5 hour sessions
Category
Prevention

2

Description
For the control group, A two-hour training program will be held.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Welfare Organization of Qom
Full name of responsible person
Leila Arbil
Street address
Qom, Imam street, Shahid Beheshti square, Welfare Organization
City
Qom

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Department of Kermanshah University of Medical Sciences
Full name of responsible person
Kourosh Hamzehei
Street address
Kermanshah, Shahid Beheshti Blvd, Building No. 2, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Department of Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Leila Arbil
Position
Graduate student in midwifery counseling
Other areas of specialty/work
Street address
Kermanshah, University of Nursing and Midwifery
City
Kermanshah
Postal code
Phone
+98 88338279899
Fax
Email
saadatmand66@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farzaneh Golboni
Position
Master's Degree of Midwifery- faculty member
Other areas of specialty/work
Street address
Kermanshah, University of Nursing and Midwifery
City
Kermanshah
Postal code
Phone
+98 888338279899
Fax
Email
farzanehgolboni@kums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Leila Arbil
Position
Graduate student in midwifery counseling
Other areas of specialty/work
Street address
Kermanshah, University of Nursing and Midwifery
City
Kermanshah
Postal code
Phone
+98 88338279899
Fax
Email
saadatmand66@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...