Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000089538
Ethics application status
Approved
Date submitted
31/05/2023
Date registered
1/02/2024
Date last updated
1/02/2024
Date data sharing statement initially provided
1/02/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
The impact of theory-based group therapy on self-efficacy and emotion regulation in East Kalimantan high-risk adolescents with mental disorders - a randomised controlled trial (RCT)
Scientific title
The Effects of Theory-based Supportive Group Therapy on Self Efficacy and Emotional Regulation Among High-risk Adolescent With Mental Disorders in East Kalimantan: a Randomised Controlled Trial (RCT)
Secondary ID [1] 309792 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High-risk adolescent with mental disorders 330202 0
Condition category
Condition code
Mental Health 329437 329437 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The activities of the intervention group will be carried out for six weeks through three stages, namely pre-test, intervention, and post-test.
Week 1 = Pre-test Measurement (DASS, GSEF, DERS, FIS, SDQ).
Weeks 2-5 =
- Providing health education on adolescent development, self-identity, depression, emotional regulation.
- Health Education will be provided during Supportive Group Therapy.
- Size and composition of supportive groups 10-20 participants and 2 researchers in each group, duration of the sessions 45-90 minutes.
- Frequency of participants attending 6 sessions over 4 weeks.
- The mode of delivery is in person at the school.
- Strategies used to monitor adherence to the intervention are attendance records and completion of worksheets.
Week 6 = Evaluation of the results of supportive group therapy activities will be carried out.
Follow-up three months = Post-test Measurement (DASS, GSEF, DERS, FIS, SDQ).
Intervention code [1] 326783 0
Treatment: Other
Intervention code [2] 327858 0
Behaviour
Comparator / control treatment
- Provision of health education on adolescent development, self-identity, depression, emotional regulation.
- Frequency of education every week for 4 weeks.
- Duration of education session 45-60 minutes.
- Delivery method by face-to-face in class.
Control group
Active

Outcomes
Primary outcome [1] 334932 0
Difficulties Emotion Regulation Scale (DERS)

Respondents rate the extent to which each item applies to them on a 5-point Likert-type scale from 1 (rarely) to 5 (almost always) (Gratz & Roemer, 2004; Gratz & Tull, 2010). Total scores on the DERS-16 can range from 16 to 80, with higher scores reflecting more significant levels of emotion dysregulation.
Timepoint [1] 334932 0
Baseline, after 6 weeks, 3 months after completion of intervention
Primary outcome [2] 334933 0
The General Self-Efficacy Scale (GSE)

The scoring system used 1 = Not at all true 2 = Hardly true 3 = Moderately true 4 = Exactly true. The range of scores on this questionnaire is 10-40 (Schwarzer & Jerusalem, 1995).
Timepoint [2] 334933 0
Baseline, after 6 weeks, 3 months after completion of intervention
Secondary outcome [1] 422482 0
self-identity assessed using the FIS Functions of Identity Scale
Timepoint [1] 422482 0
Baseline, and at 6 weeks and 3 months after the intervention
Secondary outcome [2] 422483 0
self-description assessed using the SDQ Strengths and Difficulties Questionnaire
Timepoint [2] 422483 0
Baseline, and at 6 weeks and 3 months after the intervention

Eligibility
Key inclusion criteria
1. Adolescents aged between 15 and 17 years old.
2. Have regular access to smartphones
3. Able to understand Indonesian or English
4. Registered as high school students
5. Mental disorder symptoms (moderate to severe category scale for DASS)
6. Adolescents with behavioral changes (will be screened at phase 2 with the DERS questionnaire)
7. Adolescents with Low Self-Efficacy
Minimum age
15 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Adolescents with physical disabilities.
2. Adolescents who are married.
3. Adolescents drop out of school.
4. Adolescents who are sick when data is collected.
5. Adolescents with confirmed diagnosis of mental illness.
6. Adolescents who are undergoing rehabilitation because of drug consumption

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
50 respondents From six SMA based on G-power formula calculation.
Technique Single blind method, selection of control and intervention groups using cluster sampling technique and for the selection of participants with simple random sampling.
Health vocational high school 8
Senior high school six 8
Vocational high school five 8
Senior high school seven 8
Vocational high school nineteen 9
Bhakti loa janan vocational high school 9
Total 50

Implementation Stage in the Intervention Group and Control Group
- Six weeks, and the intervention sessions will last 45 to 90 minutes. pre-test, intervention, and post-test.

Recruitment Intervention Control
Week-1 Pre-test measurement questionnaires (DASS, GSEF, DERS).

Week-2 The nurse will assess the adolescent's development and gather information about the problems faced by the adolescent. The nurse will provide health education on Health Education about development in adolescence.
Week-3 Supportive therapy to explore internal supports and barriers Health Education about self-identity
Week-4 Supportive therapy Exploration of external supports and barriers Health education about depression
Week-5 Health education about self-efficacy and health education with emotion regulation Health education about self-efficacy
Week-6 Discussion about the internal and external support systems Health education with emotion regulation and Discussion about the internal and external support systems.
Three-month follow-up Post-test measurements (DASS, GSEF, DERS).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Technique Single blind method, selection of control and intervention groups using cluster sampling technique and for the selection of participants with simple random sampling.
Health vocational high school 8
Senior high school six 8
Vocational high school five 8
Senior high school seven 8
Vocational high school nineteen 9
Bhakti loa janan vocational high school 9
Total 50
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
A sample size of 50 was calculated using a power of 80%, with a = 0.05, assuming a maximum drop-out rate of 20%. Each group size was 25. The estimated effect size at small effect d = 0.20 (Cohen, 2013).

The purpose of this study is screening, Duration Cross-sectional, sample selection with random sample and prospective study time

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
16/11/2023
Date of last participant enrolment
Anticipated
Actual
16/11/2023
Date of last data collection
Anticipated
31/03/2024
Actual
Sample size
Target
50
Accrual to date
Final
48
Recruitment outside Australia
Country [1] 25566 0
Indonesia
State/province [1] 25566 0
KALIMANTAN TIMUR

Funding & Sponsors
Funding source category [1] 313975 0
Self funded/Unfunded
Name [1] 313975 0
SITI KHOLIFAH
Country [1] 313975 0
Indonesia
Primary sponsor type
University
Name
ITKES WIYATA HUSADA SAMARINDA
Address
Selangor Branch Puncak Alam Campus BANDAR PUNCAK ALAM, 42300 Kuala Selangor, Selangor, Malaysia
Country
Indonesia
Secondary sponsor category [1] 317787 0
University
Name [1] 317787 0
ITKES WIYATA HUSADA SAMARINDA
Address [1] 317787 0
Country [1] 317787 0
Indonesia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313110 0
HEALTH RESEARCH ETHICS COMMITTEE HEALTH POLYTECHNIC OF MINISTRY OF HEALTH EAST KALIMANTAN
Ethics committee address [1] 313110 0
Ethics committee country [1] 313110 0
Indonesia
Date submitted for ethics approval [1] 313110 0
17/05/2023
Approval date [1] 313110 0
16/11/2023
Ethics approval number [1] 313110 0
DP.04.001/7.1/07763/2023

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127038 0
Mrs SITI KHOLIFAH
Address 127038 0
Jl. Kadrie Oening Gang Monalisa No.77, Air Hitam, Kec. Samarinda Ulu, Kota Samarinda, Kalimantan Timur . Indonesia, 75243
Country 127038 0
Indonesia
Phone 127038 0
+6281253559986
Fax 127038 0
Email 127038 0
[email protected]
Contact person for public queries
Name 127039 0
SITI KHOLIFAH
Address 127039 0
Institut Teknologi Kesehatan dan Sains (ITKES) Wiyata Husada Samarinda (WHS)Jl. Kadrie Oening Gang Monalisa No.77, Air Hitam, Kec. Samarinda Ulu, Kota Samarinda, Kalimantan Timur 75243
Country 127039 0
Indonesia
Phone 127039 0
+6281253559986
Fax 127039 0
Email 127039 0
[email protected]
Contact person for scientific queries
Name 127040 0
SITI KHOLIFAH
Address 127040 0
Institut Teknologi Kesehatan dan Sains (ITKES) Wiyata Husada Samarinda (WHS)Jl. Kadrie Oening Gang Monalisa No.77, Air Hitam, Kec. Samarinda Ulu, Kota Samarinda, Kalimantan Timur 75243
Country 127040 0
Indonesia
Phone 127040 0
+6281253559986
Fax 127040 0
Email 127040 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19548Informed consent form https://drive.google.com/drive/folders/1lmtd7--oNXQYWX6VWKgh22ye_vw5hkG7?usp=sharing[email protected] 385995-(Uploaded-25-01-2024-19-42-55)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.