Effectiveness of Parent-Child Interaction Therapy on reducing behavioral problems and improving the parent-child relationship in children with attention deficit hyperactivity disorder
At present, no research has investigated the effectiveness of coaching and behavioral coding treatment in Iran, and the results of this study can be used to evaluate the effectiveness of PCIT for children with ADHD, improve parenting styles. This treatment will be the pioneer of other researches and effective therapeutic interventions at this field.
Design
This research will be an RCT with a pre-test and post-test design with a control group and two four-month test and follow-up groups: the first group of father-child pairs receiving PCIT, the second group of mother-child pairs receiving PCIT, and the third group of the control group (list waiting) who do not receive intervention until the end of the research.
Settings and conduct
it will be held in Sanandaj city and in Afra psychological counseling center under the management of Mr. Samad Hamidi (PCIT therapist) equipped with closed-circuit camera and one-way mirror. Sampling will be block randomization.
Participants/Inclusion and exclusion criteria
Children aged 3 to 7 years should score at or above the borderline on the Conner's Parent-Teacher Scale.
parents who have special medical conditions or active substance dependence or do not want to record and videotape therapy sessions, do not have enough time to participate in sessions and do exercises at home, are not motivated enough to participate in sessions. Children with co-morbid Autism Spectrum Disorders and other developmental disabilities or mental retardation
Intervention groups
The first experimental group of 40 father-child pairs
The second experimental group of 40 mother-child pairs
Waiting group for father/mother-child pairs of 40 people
Main outcome variables
Effectiveness of PCIT on improving father-child and mother-child relationships, fathers and mother's parenting capacity, and reducing behavioral problems in children will be investigated.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160530028182N12
Registration date:2024-02-20, 1402/12/01
Registration timing:retrospective
Last update:2024-02-20, 1402/12/01
Update count:0
Registration date
2024-02-20, 1402/12/01
Registrant information
Name
Soleiman Mohammadzadeh
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 3323 2168
Email address
dr.mohammadzadeh86@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-07-07, 1402/04/16
Actual recruitment start date
2022-12-22, 1401/10/01
Actual recruitment end date
2023-07-07, 1402/04/16
Trial completion date
empty
Scientific title
Effectiveness of Parent-Child Interaction Therapy on reducing behavioral problems and improving the parent-child relationship in children with attention deficit hyperactivity disorder
Public title
Effectiveness of Parent-Child Interaction Therapy on attention deficit hyperactivity disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
3-7 year old children
diagnosed with moderate and severe ADHD through a child and adolescent psychiatrist and the Connors scale of parents and teachers
Exclusion criteria:
Parents with specific medical conditions or substance dependence
Parents who do not wish to record and videotape therapy sessions,
Parents who do not have enough time to participate in meetings and practice at home.
Patients who are not motivated enough to attend meetings.
Children with autism spectrum disorders and other developmental disabilities or mental retardation based on clinical interview.
Age
From 3 years old to 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
120
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use the restricted randomization method of the block randomization type. Blocking is usually used to balance the number of samples allocated to each studied group. Random allocation software will also be used for randomization. We will utilize allocation concealment, which is a method for performing a random sequence on research subjects such that the allocated group is unknown prior to the individual's allocation. Using sequentially numbered, opaque sealed envelopes (SNOSE) is a cheap and effective way to disguise the randomization sequence, despite the fact that numerous methods of randomization are known to do so. In this method, each of the generated random sequences is recorded on a card and the cards are placed in the envelopes in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of the registration of the participants, based on the order in which the eligible participants entered the study, one of the envelopes will be opened, and the assigned group of that participant will be revealed.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, we will use the restricted randomization method of the block randomization type. Blocking is usually used to balance the number of samples allocated to each studied group. Random allocation software will also be used for randomization. We will utilize allocation concealment, which is a method for performing a random sequence on research subjects such that the allocated group is unknown prior to the individual's allocation. Using sequentially numbered, opaque sealed envelopes (SNOSE) is a cheap and effective way to disguise the randomization sequence, despite the fact that numerous methods of randomization are known to do so. In this method, each of the generated random sequences is recorded on a card and the cards are placed in the envelopes in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of the registration of the participants, based on the order in which the eligible participants entered the study, one of the envelopes will be opened, and the assigned group of that participant will be revealed.
Placebo
Not used
Assignment
Crossover
Other design features
Therapeutic interventions are implemented based on the "treatment manual" on the participants of the two experimental groups. The participants of the control group are placed on the waiting list and receive intervention services at the end of the study. After the last meeting, the post-test is done on the experimental and waiting group, and the follow-up of the groups is done four months after the last meeting. The quality of parent-child interaction will be measured based on a parent-child interaction questionnaire and behavioral observations of parent-child interaction using a one-way mirror as well as 15-minute video observations. To code the behavioral observations, the DPICS-III third edition parent-child interaction coding system will be used. All parent-child interactions are coded in four groups: verbalization, vocalization, physical contact, and answer. Parents and children play on a table in a playroom equipped with a closed-circuit camera and a one-way mirror, and trained therapist and coders observe, evaluate, and coach the sessions, and the sessions are filmed, and at the end of each session and these films reviewed by two people who are familiar with the DPICS coding system (who were not present during the intervention and did not observe the sessions live) and all parent-child dialogues are written on a sheet and coded based on this coding system and finally Inter-rater reliability is also scored (based on the DPICS coding system). In this treatment, the parent is coached by the therapist every moment and his verbal and non-verbal mistakes are corrected instantly. Parents use a bug-in-ear device to hear the therapist's instructions. In each session, an observer evaluates the therapist's "fidelity to the guidelines" in the "Clinical Guide to Therapy". The therapist is responsible for both coaching and coding sessions. So far in Iran, PCIT research has not been done in the form of "direct coding and coaching by the therapist". And the treatment in the form of direct "coaching" is the first time that it is implemented in Iran. The therapist of this research will be Mr. Samad Hamidi, and he has complete expertise in the coaching and coding of the sessions, and the sessions are conducted under the direct supervision of Dr. Cheryl McNeil, will be implemented from Florida International University . Mr. Hamidi will implement this approach in Iran for the first time under his clinical supervision.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kurdistan University of Medical Sciences
Street address
No. 1, Pasdaran Blvd. Sanandaj Town
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Approval date
2023-10-17, 1402/07/25
Ethics committee reference number
IR.MUK.REC.1402.220
Health conditions studied
1
Description of health condition studied
Attention-Deficit Hyperactivity Disorder
ICD-10 code
F90.0
ICD-10 code description
Attention-deficit hyperactivity disorder, predominantly inattentive type
Primary outcomes
1
Description
Improving parent-child interactions based on the DPICS coding system, the international PCIT system, mastery criteria based on the treatment guide, 10 behavioral descriptions, 10 feedback and 10 titled rewards, and 3 or less negative sentences, reducing children's behavioral problems based on ECBI less than 114.
Timepoint
Before the start of the two baseline interventions, the week 1 and 2, the middle of the treatment after the implementation of the CDI phase, the first stage of the treatment, the 10th week, and the end of the treatment, the 20th week and 4 months after the end of the treatment for follow-up.
Method of measurement
The Dyadic Parent-Child Interaction Coding System, Eyberg child behavior inventory, Therapy Attitude Inventory, Conners' Parent Rating Scales, Early Intervention Parenting Self-Efficacy, Difficulties in Emotion Regulation Scale, Parenting stress index - short form, Alabama Parenting Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group 1: father-child pair. 40 fathers with their children aged 3 to 7 years with ADHD are randomly placed in this group. They will receive treatment in weekly sessions for 20 weeks. Father-child pairs will play in the treatment room and will be observed by a trained therapist in the room and coached from behind a one-way mirror using the bug in ear system.
Category
Treatment - Other
2
Description
Intervention group 2: mother-child pair. 40 mother with their children aged 3 to 7 years with ADHD are randomly placed in this group. They will receive treatment in weekly sessions for 20 weeks. Mother-child pairs will play in the treatment room and will be observed by a trained therapist in the room and coached from behind a one-way mirror using the bug in ear system.
Category
Treatment - Other
3
Description
Control group: parent couple (mother/father)-child. 40 parents (mothers/fathers) with children aged 3 to 7 years with ADHD are randomly placed in this waiting group. Until the end of the research, this group will not receive any intervention, but after the end of the research, they will receive weekly sessions for 20 weeks. Parents-child pairs will play in the treatment room and will be observed by a trained therapist in the room and coached from behind a one-way mirror using the bug in ear system.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital Sanandaj
Full name of responsible person
Soliman Mohammadzadeh
Street address
No. 1, Keshavarz St., South Mardukh St., Sanandaj Town
City
Sanandaj
Province
Kurdistan
Postal code
6617113141
Phone
+98 87 3328 5910
Fax
+98 87 3328 5911
Email
dr.mohammadzadeh86@muk.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Afshin Malaki
Street address
No. 1, Pasdaran Blv. Sanandaj Town
City
Sanandaj
Province
Kurdistan
Postal code
6617978743
Phone
+98 87 3366 4957
Email
dr.mohammadzadeh86@muk.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Soliman Mohammadzadeh
Position
Associated Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
No. 1, Pasdaran Blvd.
City
Sanandaj
Province
Kurdistan
Postal code
6617978743
Phone
+98 87 3366 4957
Email
dr.mohammadzadeh86@muk.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Soliman Mohammadzadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
No. 1, Pasdaran Blvd.
City
Sanandaj
Province
Kurdistan
Postal code
6617978743
Phone
+98 87 3366 4957
Fax
Email
dr.mohammadzadeh86@muk.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Soliman Mohammadzadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
No. 1. Pasdaran Blvd.
City
Sanandaj
Province
Kurdistan
Postal code
6617978743
Phone
+98 87 3366 4957
Email
dr.mohammadzadeh86@muk.ac.ir
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
Not applicable
Title and more details about the data/document
Individual data of participants
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
People working in academic institutions
Under which criteria data/document could be used
Researchers in this field
From where data/document is obtainable
dr.mohammadzadeh86@muk.ac.ir
What processes are involved for a request to access data/document