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IRCT20160530028182N12 IRCT 2024-02-20 Sanandaj University of Medical Sciences Effectiveness of Parent-Child Interaction Therapy on attention deficit hyperactivity disorder Effectiveness of Parent-Child Interaction Therapy on reducing behavioral problems and improving the parent-child relationship in children with attention deficit hyperactivity disorder 2022-12-22 anticipated 120 Complete https://irct.ir/trial/71124 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, 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, 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 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. N/A Attention-Deficit Hyperactivity Disorder. Intervention 1: 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. Intervention 2: 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. Intervention 3: 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. Yes - There is a plan to make this available What will be shared: Individual data of participants When: 6 months after the results are published To whom: People working in academic institutions Conditions: Researchers in this field Where to obtain: dr.mohammadzadeh86@muk.ac.ir How to obtain: 2 Month Comments:
public Soliman Mohammadzadeh
No. 1, Pasdaran Blvd.
Sanandaj Iran (Islamic Republic of) 6617978743 +98 87 3366 4957 dr.mohammadzadeh86@muk.ac.ir Sanandaj University of Medical Sciences scientific Soliman Mohammadzadeh
No. 1, Pasdaran Blvd.
Sanandaj Iran (Islamic Republic of) 6617978743 +98 87 3366 4957 dr.mohammadzadeh86@muk.ac.ir Sanandaj University of Medical Sciences Iran (Islamic Republic of) 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 3 years 7 years Both 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. F90.0 Attention-deficit hyperactivity disorder, predominantly inattentive type Treatment - Other Treatment - Other Treatment - Other 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. 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. 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. 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. Sanandaj University of Medical Sciences Approved 2023-10-17 Ethics Committee of Kurdistan University of Medical Sciences No. 1, Pasdaran Blvd. Sanandaj Town Sanandaj Kurdistan Iran (Islamic Republic of)