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IRCT20220714055467N1 IRCT 2022-09-28 Shiraz University Effect of Parent-Focused Group Schema Therapy for Adolescents with Anorexia Nervosa: The Effectiveness of Parent-Focused Group Schema Therapy in Reducing Clinical Symptoms and Improving Parent-Child Relationship Among Adolescents with Anorexia Nervosa 2022-06-22 anticipated 18 Complete https://irct.ir/trial/64874 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Other design features: For the quantitative part of this pilot study, the single-case design has been chosen because it is an approach often advocated for early phase behavioral studies. SCD is suggested as an economical and flexible approach used in the experimental analysis of behavior and applied behavior analysis and it experimentally demonstrate that a change in targeted behavior results from a novel intervention, and that the behavior change, in turn, is associated with clinically meaningful improvements in health outcomes. Three essential characteristics of a SCD which will be performed in this study are the followings: data will be gathered, analyzed and interpreted for 3 groups of participants) (2) the participants will be observed repeatedly during baseline and treatment phases, and (3) outcomes during and after the treatment will be compared with outcomes before treatment. These groups provide their own controls for purpose of comparison. Additional advantages of SCD include the ability to study highly fragmented populations that have a low prevalence rate or have rare diseases (The same as patients with eating disorders in this study) , the reduction in the gap between research and practice by allowing the therapists to implement SCD in natural setting, the provision of detailed information about variations in the treatment effect related to participant’s individual differences, and assessment of treatment effectiveness trends over time, Randomization description: In this non-concurrent multiple baseline design, the researchers introduce the intervention to three groups on a staggered schedule and in a random order. The randomization assignment will be simple and individual, also will be done by means of table of random numbers. Before any intervention occurs, the outcome is measured in each group( the baseline phase). Then the intervention is initiated in 1 group while the others continue in the control and baseline condition. After sufficient time has passed for the intervention to affect the outcome in the first group, outcome measurements are conducted in all groups and the intervention is introduced in second and third groups. This proceeds until all groups receive the intervention. Once a group starts the intervention, it remains in that condition until the end of the study. If every group shows a similar change after crossing to the intervention condition and does not change at other times, the experiment provides compelling evidence that the changes resulted from the intervention, Blinding description: In this study, the parents as participants are blind. Meaning that they do not know in which group they will enter. In this non-concurrent multiple baseline design, the researchers introduce the intervention to three groups on in a random order and the parents do not have an idea of in which group they will enter. N/A Anorexia Nervosa. Intervention 1: Intervention group: 18 parents of adolescents with Anorexia Nervosa after being clinically assessed and diagnosed, will be randomly allocated to this group. Participants will undergo the online parent-focused group schema therapy once a week for 90 minutes, in total 12 weeks. The adolescents' symptoms measurements and measures related to parents as participants will be made at baseline, mid, post treatment and 3 months follow-up. Intervention 2: Control group: 18 parents of adolescents with Anorexia Nervosa after being clinically assessed and diagnosed, will be randomly allocated to this group. Measurements will be made at baseline, mid, post treatment and 3 months follow-up simultaneously and in accordance with the intervention group. No - There is not a plan to make this available Justification or reason for not sharing IPD is Considering ethical codes
public Javad Molazadeh
Jomhoori Eslami Blvd.
Shiraz Iran (Islamic Republic of) 7194684759 +98 21 6621 9473 molazadeh@shirazu.ac.ir Shiraz University scientific Javad Molazadeh
Jomhoori Eslami Blvd.
Shiraz Iran (Islamic Republic of) 7194684759 +98 21 6621 9473 molazade@shirazu.ac.ir Shiraz University Iran (Islamic Republic of) Parents of adolescents between the ages of 12 and 18 Having at least a caregiver in the home willing to participate in treatment Adolescents must meet DSM-5 criteria for Anorexia Nervosa based on the clinical interview Having body mass index (BMI) between 14 and 18 Being sufficiently medically stable for outpatient treatment Parents must read and speak Persian to at least a sixth-grade level Adolescents on psychotropic medication must be on a stable dose for a period of at least 8 weeks 11 years 18 years Both Adolescents with severe substance abuse, acute psychosis, or at acute risk for suicide Adolescents or caregivers with intellectual disability Experience of participating in Schema Therapy sessions with a trained clinician over the past 12 months before the study begins Report of a current or history of recent or past physical or sexual abuse by a family member F50.0 Anorexia nervosa Treatment - Other Treatment - Other Intervention group: 18 parents of adolescents with Anorexia Nervosa after being clinically assessed and diagnosed, will be randomly allocated to this group. Participants will undergo the online parent-focused group schema therapy once a week for 90 minutes, in total 12 weeks. The adolescents' symptoms measurements and measures related to parents as participants will be made at baseline, mid, post treatment and 3 months follow-up. Control group: 18 parents of adolescents with Anorexia Nervosa after being clinically assessed and diagnosed, will be randomly allocated to this group. Measurements will be made at baseline, mid, post treatment and 3 months follow-up simultaneously and in accordance with the intervention group. The score of the Eating Disorder Examination questionnaire (EDEQ). Timepoint: Measuring the eating disorder in Baseline, Mid-treatment, post-treatment and 3- month follow-up. Method of measurement: Eating Disorder Examination questionnaire (EDEQ). The score of Parent-Child Interaction Questionnaire-Revised (PACHIQ-R). Timepoint: Measuring the parent-child interaction in Baseline, Mid-treatment, post-treatment and 3- month follow-up. Method of measurement: Parent-Child Interaction Questionnaire-Revised (PACHIQ-R). The score of Difficulties in Emotion Regulation Scale (DERS-16). Timepoint: Measuring the parents' emotion regulation in Baseline, Mid-treatment, Post-treatment and 3-months follow-up. Method of measurement: The Difficulties in Emotion Regulation Scale (DERS-16). The score of Family Quality of Life Scale (FQOL). Timepoint: Measuring the family's quality of life in Baseline, Mid-treatment, Post-treatment and 3-months follow-up. Method of measurement: Family Quality of Life Scale (FQOL). The score of Visual Analogue Scale (VAS). Timepoint: The VAS scales will be collected twice per week during baseline period, once a week after each group session, twice per week during the follow-up and once during the follow-up measure. Method of measurement: Visual Analogue Scale (VAS). Shiraz University Approved 2022-06-20 Research Ethics Committees of Shiraz University of Medical Sciences Department of clinical psychology, Shiraz University, Jomhoori Eslami Blvd, Shiraz, Fars, Iran Shiraz Fars Iran (Islamic Republic of)