Protocol summary

Study aim
Determining the effectiveness of Child–Parent Relationship Therapy (CPRT) on the parent–child relationship quality and parenting stress of parents of children with visual impairment Determining the effectiveness of CPRT on the parent–child relationship quality of parents of children with visual impairment Determining the effectiveness of CPRT on the parenting stress of parents of children with visual impairment
Design
A clinical trial with two groups (experimental and control), single-blind, randomized, conducted on 32 participants (16 in each group). Randomization was performed using block randomization.
Settings and conduct
Preschools and special schools in Mashhad Conducted using the Strengths and Difficulties Questionnaire (SDQ) Participants randomly assigned to experimental and control groups Procedure: Pre-test → Intervention → Post-test → Follow-up Single-blind from the participants’ perspective
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Child has a visual impairment Child’s age is between 6 and 9 years Parental consent to participate in the study Parents have at least a high school diploma High scores on the relevant questionnaires Exclusion Criteria: Withdrawal from participation Absence from more than two sessions Incomplete completion of questionnaires Concurrent participation in other psychotherapy sessions Requirement for psychiatric medication Use of psychiatric medication within six months prior to the study Simultaneous receipt of other psychotherapeutic services Visual impairment in parents Psychiatric disorders
Intervention groups
The intervention for the experimental group consisted of CPRT. The intervention for the control group consisted of psychoeducational training on children’s developmental needs (a neutral intervention).
Main outcome variables
Enhancement of relationship quality Reduction of parenting stress

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250702066336N1
Registration date: 2025-10-17, 1404/07/25
Registration timing: registered_while_recruiting

Last update: 2025-10-17, 1404/07/25
Update count: 0
Registration date
2025-10-17, 1404/07/25
Registrant information
Name
Leila Salek Ebrahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 0367
Email address
salekebrahimi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-23, 1404/07/01
Expected recruitment end date
2026-01-21, 1404/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of child-parent relationship play therapy (CPRT) in the quality of relationship and parenting stress in parents of children with visual
Public title
Efficacy of child-parent relationship play therapy (CPRT) in the quality of relationship and parenting stress in parents of children with visual
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Vision problems in the child Age 6 to 9 years in children Full parental consent to participate in the research Parents must have at least a 12th grade education. Having high scores on parenting stress and relationship quality questionnaires before intervention
Exclusion criteria:
Regrets about participating in the study Missing more than two therapy sessions Failure to complete questionnaires by parents Simultaneous participation in other psychotherapy sessions The need to take psychiatric medications during intervention sessions Drug therapy from six months before the study to its start Receiving other psychotherapy services simultaneously by the parent or child Presence of vision problems in parents Presence of psychiatric problems including attention deficit hyperactivity disorder, mental retardation, and autism spectrum disorder
Age
From 6 years old to 9 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation of participants to the experimental and control groups will be carried out using the block randomization method. For this purpose, blocks of four will be applied. Six blocks will be created from all possible permutations of these four combinations. The list of these permutations will be provided below. At each step, one of these blocks will be randomly selected, and allocation will be made according to the order specified in that block. This procedure will be performed using statistical software by a statistical consultant; therefore, the interventionist will remain unaware of the allocation of the next participant.
Blinding (investigator's opinion)
Single blinded
Blinding description
Given that the participant is not aware of whether they have been assigned to the control group or the experimental group, and that the intervention they receive—either the main intervention (Parent–Child Relationship–Based Play Therapy) or the neutral intervention (psychoeducational training on developmental needs)—the intervention is considered participant-blinded.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Tabriz University of Medical Sciences
Street address
Golgasht street, Central Building No. 2, 3rd Floor, office of the Vice Chancellor for Research and Technology. Tabriz University of Medical sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2025-10-06, 1404/07/14
Ethics committee reference number
IR.TBZMED.REC.1404.505

Health conditions studied

1

Description of health condition studied
quality of relationship - parenting stress
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Relationship quality score in the Pianta Parent-Child Questionnaire
Timepoint
Measurement of relationship quality at pre-test, post-test (after the intervention), and follow-up stages for both groups
Method of measurement
Pianta Parent-Child Questionnaire

2

Description
Parental stress score in the Abidin Short Form Parenting Stress Index
Timepoint
Measurement of parental stress at pre-test, post-test (after the intervention), and follow-up stages for both groups
Method of measurement
Abidin Short Form Parenting Stress Index

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The parents of children with visual impairments who meet the inclusion and exclusion criteria of the target population and are selected through convenience sampling will be assigned to the experimental group using block randomization for treatment.
Category
Behavior

2

Description
Control group: The parents of children with visual impairments who meet the inclusion and exclusion criteria mentioned above and are selected through convenience sampling will be assigned to the control group using block randomization. For the members of this group as well, group psychoeducational sessions will be held focusing on the developmental needs of children.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Preschools and special education schools in the city of Mashhad
Full name of responsible person
Mahla Mohammaddust
Street address
No. 79 Ebadi St., corner of Hani 4, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9147786334
Phone
+98 930 626 8764
Email
Mahlamohamaddost@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
دکتر خسرو ادیب کیا
Street address
Golgasht street, Central Building No. 2, 3rd Floor, office of the Vice Chancellor for Research and Technology. Tabriz University of Medical sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 7310
Email
adibkia@tbzmed.ad.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Leila Salek Ebrahimi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 130, Montazeri Ave., Ashtab Alley., Tabriz City
City
Tabriz
Province
East Azarbaijan
Postal code
5163916353
Phone
+98 41 3335 0367
Fax
Email
salekebrahimi@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Leila Salek Ebrahimi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 130, Montazeri Ave., Ashtab Alley., Tabriz City
City
Tabriz
Province
East Azarbaijan
Postal code
5163916353
Phone
+98 41 3335 0367
Fax
Email
salekebrahimi@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahla Mohammaddust
Position
Master’s degree student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 79 Ebadi St., corner of Hani 4, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9147786334
Phone
+98 930 626 8764
Email
mahlamohamaddost@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data obtained from the pre-test, post-test, and follow-up assessments can be shared after de-identifying the participants.
When the data will become available and for how long
The access period will begin one year after the publication of the results.
To whom data/document is available
It will be available to students and researchers affiliated with academic and scientific institutions.
Under which criteria data/document could be used
Researchers are permitted to use the data provided that it is utilized for scientific and research purposes.
From where data/document is obtainable
mahlamohamaddost@gmail.com
What processes are involved for a request to access data/document
Obtaining an introduction letter from the university or institution with which the researcher is affiliated.
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