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The Effectiveness of Parent-Focused Group Schema Therapy in Reducing Clinical Symptoms and Improving Parent-Child Relationship Among Adolescents with Anorexia Nervosa

Protocol summary

Study aim
The current study aims to investigate the effectiveness of the group schema therapy in reducing the clinical symptoms of adolescents with Anorexia Nervosa, improving parents emotion regulation skills, parent-child interaction and family quality of life.
Design
The multiple baseline design across three groups of 6 people, with control groups, currently in the recruitment phase, with blinded participants, random assignment to each group, using the table of random numbers.
Settings and conduct
This online intervention will be held on Google Meet platform, once a week, for 90 minutes. The parents as participants are blind and they do not know in which group they will enter.
Participants/Inclusion and exclusion criteria
Adolescents must be between the ages of 12 and 18. Having a caregiver in the home willing to participate in treatment. (BMI) between 14 and 18, Meeting DSM-5 criteria for Anorexia Nervosa Being sufficiently stable for outpatient treatment, Being on a stable medication dose for a period of at least 8 weeks before the intervention. Exclusion Criteria: Adolescents with current severe substance abuse, current acute psychosis, or at acute risk for suicide and intellectual disability. Participants who have had schema therapy sessions over the past 12 months before the study begins Current or a history of recent or past physical or sexual abuse by a family member.
Intervention groups
Intervention group: 18 parents of adolescents with Anorexia Nervosa after being assessed 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. Control group: 18 parents of adolescents with Anorexia Nervosa that measurements will be made simultaneously and in accordance with the intervention group.
Main outcome variables
Anorexia symptoms, Parent-child interaction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220714055467N1
Registration date: 2022-09-28, 1401/07/06
Registration timing: registered_while_recruiting

Last update: 2022-09-28, 1401/07/06
Update count: 0
Registration date
2022-09-28, 1401/07/06
Registrant information
Name
Fatemeh Seifi
Name of organization / entity
Shiraz University
Country
Iran (Islamic Republic of)
Phone
+98 21 6621 9473
Email address
fatemeh.seifi@shirazu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2023-01-20, 1401/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Parent-Focused Group Schema Therapy in Reducing Clinical Symptoms and Improving Parent-Child Relationship Among Adolescents with Anorexia Nervosa
Public title
Effect of Parent-Focused Group Schema Therapy for Adolescents with Anorexia Nervosa:
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 11 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 18
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Other
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.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Shiraz University of Medical Sciences
Street address
Department of clinical psychology, Shiraz University, Jomhoori Eslami Blvd, Shiraz, Fars, Iran
City
Shiraz
Province
Fars
Postal code
7194684759
Approval date
2022-06-20, 1401/03/30
Ethics committee reference number
IR.SUMS.REC.1401.212

Health conditions studied

1

Description of health condition studied
Anorexia Nervosa
ICD-10 code
F50.0
ICD-10 code description
Anorexia nervosa

Primary outcomes

1

Description
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)

2

Description
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)

Secondary outcomes

1

Description
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)

2

Description
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)

3

Description
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)

Intervention groups

1

Description
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.
Category
Treatment - Other

2

Description
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.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Clinical Psychology
Full name of responsible person
Javad Molazadeh
Street address
Jomhoori Eslami Blvd
City
Shiraz
Province
Fars
Postal code
7194684759
Phone
+98 912 802 0965
Email
fatemeh.seifi@shirazu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University
Full name of responsible person
Mohammad Hadi Sadeghi
Street address
Jomhoori Eslami Blvd.
City
Shiraz
Province
Fars
Postal code
7194684759
Phone
+98 21 6621 9473
Email
sadeghi@shirazu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University
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
Shiraz University
Full name of responsible person
Javad Molazadeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Jomhoori Eslami Blvd.
City
Shiraz
Province
Fars
Postal code
7194684759
Phone
+98 21 6621 9473
Email
molazadeh@shirazu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University
Full name of responsible person
Javad Molazadeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Jomhoori Eslami Blvd.
City
Shiraz
Province
Fars
Postal code
7194684759
Phone
+98 21 6621 9473
Email
molazade@shirazu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University
Full name of responsible person
Fatemeh Seifi
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Jomhoori Eslami Blvd.
City
Shiraz
Province
Fars
Postal code
7194684759
Phone
+98 21 6621 9473
Email
fatemeh.seifi@shirazu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Considering ethical codes
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
No - There is not 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
Sharing the protocol and the treatment outcomes
When the data will become available and for how long
Accessing the data from 2023
To whom data/document is available
Researchers working in academic and scientific institutes.
Under which criteria data/document could be used
After official publishing in valid scientific journals will be accessible.
From where data/document is obtainable
fatemeh.seifi@shirazu.ac.ir
What processes are involved for a request to access data/document
After 2 years, the person who requests, can accsess the protocol and treatment outcomes, after the article being published officially.
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