The aim of this study will be investigate the effectiveness of parent-child interactive group therapy (PCIT) on the improvement of affective index in children with methadone-treated parents.
Design
a clinical trial in the form of a semi-experimental study
Settings and conduct
40 mothers and children will be selected through respondent-driven sampling method and will be assigned in two groups by block randomization.
Participants/Inclusion and exclusion criteria
The inclusion criteria were: age range of 5-7 years in children, age range of 18-45 years in mothers, the under methadone treatment with a given dose for at least one of the parents. The exclusion criteria was: More than two absences in treatment sessions.
Intervention groups
PCIT will be in twelve weekly sessions and changes in the level of affection.
Main outcome variables
The Positive and Negative Affect Schedule (PANAS)
General information
Reason for update
Acronym
parent-child interaction therapy (PCIT)
IRCT registration information
IRCT registration number:IRCT20150503022061N1
Registration date:2019-03-01, 1397/12/10
Registration timing:prospective
Last update:2019-03-01, 1397/12/10
Update count:0
Registration date
2019-03-01, 1397/12/10
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 22081450
Email address
bijanpirnia@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-31, 1398/03/10
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
2019-09-28, 1398/07/06
Actual recruitment end date
2019-10-23, 1398/08/01
Trial completion date
2020-01-21, 1398/11/01
Scientific title
The Effectiveness of parent-child interaction therapy on the Improvement of Affective Index in Children
Public title
parent-child interaction therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age range of 5-7 years for children
age range of 18-45 years for mothers
the under methadone treatment with a given dose for at least one of the parents
Exclusion criteria:
More than two absences in treatment sessions
Age
From 5 years old to 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blocks Randomization:
Block randomization works by randomizing participants within blocks such that an equal number are assigned to each treatment. Allocation proceeds by randomly selecting one of the orderings and assigning the next block of participants to study groups according to the specified sequence. A disadvantage of block randomization is that the allocation of participants may be predictable
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
IR.SBMU. RETECH.REC. 1397.628
Street address
Behavioral Sciences Research Center of Shahid Beheshti University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1981999751
Approval date
2018-11-04, 1397/08/13
Ethics committee reference number
IR.SBMU. RETECH.REC. 1397.628
Health conditions studied
1
Description of health condition studied
Affective disorder
ICD-10 code
F34
ICD-10 code description
Persistent mood [affective] disorders
Primary outcomes
1
Description
affective syndrome
Timepoint
Pre test and post test after 12 sessions therapy.
Method of measurement
The Positive and Negative Affect Schedule (PANAS)
Secondary outcomes
1
Description
Anxiety
Timepoint
Pre test and post test after 12 sessions therapy
Method of measurement
Beck Anxiety Index (BAI)
Intervention groups
1
Description
Intervention group: Parent-child interaction therapy (PCIT). PCIT Protocol (UC Davis PCIT Training Center, Sacramento) will be conducted in two phases of child directed interaction (to improve communication) and parent directed interaction (to practice interactive discipline) in twelve sessions. The treatment was presented in the form of 8 weekly sessions.
Category
Behavior
2
Description
Control group: In this study, the control group was merely receiving routine center therapy and did not receive intervention.