IRCT | Investigating the effectiveness of an intervention based on psychosocial support compared to standard care on pregnancy outcomes in adolescent pregnancy.

Protocol summary

Study aim: Evaluation of the effect of a designed intervention based on psychosocial support of pregnant adolescents on the outcome of pregnancy
Design: It is a single blind clinical trial with a control group and a sample size of 84. The study population is adolescent pregnant women who meet the criteria for entering the study. The method of random allocation is block randomization. In order to hide the random allocation, sealed non-transparent envelopes with a random sequence are used.
Settings and conduct: The researcher will go to one of the health centers in the east and west of Ahvaz and will identify eligible mothers to participate in the study. Due to the nature of this study, it will not be possible to blind the researcher and the participant. But the results of the questionnaires will be collected by another person who is not aware of the objectives of the study.
Participants/Inclusion and exclusion criteria: Inclusion criteria: Low-risk singleton pregnancy; Being at the age of 13-19 years old; Gestational age of 12-28 weeks. Non inclusion criteria: Having a known physical or mental illness; Consumption of alcohol and tobacco by the mother
Intervention groups: In the intervention group, participants will receive 4-6 training sessions based on psychosocial support. Depending on the content, the number of sessions may vary. Group sessions of 4 to 10 people will be offered during pregnancy. In the control group, the researcher will provide only routine supportive care.
Main outcome variables: Social support; Pregnancy outcome

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20190129042544N1

Registration date: 2023-06-26, 1402/04/05

Registration timing: registered_while_recruiting

Last update: 2023-06-26, 1402/04/05

Update count: 0
Registration date: 2023-06-26, 1402/04/05

Registrant information: Name

setareh yousefi

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 71 5450 4504

Email address

yousefi.setareh@gmail.com

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2023-06-20, 1402/03/30
Expected recruitment end date: 2025-06-20, 1404/03/30
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Investigating the effectiveness of an intervention based on psychosocial support compared to standard care on pregnancy outcomes in adolescent pregnancy.

Public title: The impact of psycho-social support interventions on pregnancy outcomes.
Purpose: Education/Guidance
Inclusion/Exclusion criteria: Inclusion criteria:

Ability to understand and speak Persian Low-risk singleton pregnancy Gestational age 12-28 weeks Being literate in reading and writing Being at the age of 13-19 years old

Exclusion criteria:

Discovering abnormalities in the fetus Having a known physical or mental illness Consumption of alcohol and tobacco by the mother
Age: From 13 years old to 19 years old
Gender: Female

Phase

N/A

Groups that have been masked

Outcome assessor
Data analyser

Sample size

Target sample size: 84

Randomization (investigator's opinion)

Randomized

Randomization description

"Due to the limited number of teenage pregnant mothers and the nature of the clinical trial, the researcher will refer to health centers in the east and west of Ahvaz to determine eligible and willing mothers to participate in the study. If the desired sample volume is not provided, the researcher will continue to other centers until reaching the desired sample volume. The samples will then be divided into two groups, an intervention group, and a control group, using the random block method. All possible modes of placement of letters A (intervention) and B (control) will be considered in blocks of 6 with an allocation ratio of 1:1. The number of required blocks will be determined based on the number of studied samples. Then, based on the table of random numbers and the number of required blocks, the blocks corresponding to each table number will be listed in order. When the samples enter the study, each person will be assigned a certain letter according to the obtained order. For example, according to the order (AAABBB/ABABAB), the seventh person will be placed in the intervention group (A). To hide the allocation, sequentially numbered sealed envelopes will be used, with the type of intervention written inside. To hide the random allocation, the method of non-transparent sealed envelopes with random sequences will be used. First, a random sequence will be created by a person who is unaware of the goals and subject of the study. Based on the sample size of the research (84 people), 84 opaque envelopes will be prepared. Each of the random sequences created by the person will be recorded on a card, and the cards will be placed in the envelopes in order. Finally, the envelopes will be sealed and placed in a box, which will be kept by the midwife of the center. When the researcher starts sampling, one of the envelopes will be opened based on the order in which the eligible participants entered the study, and the specialized group of that participant will be revealed. Due to the nature of this study, it will not be possible to blind the researcher and the participant. However, the results of the questionnaires will be collected by another person who is not aware of the study's objectives."

Blinding (investigator's opinion)

Single blinded

Blinding description

Due to the nature of this study, it will not be possible to blind the researcher and the participant, but the results of the questionnaires will be collected by another person who is not aware of the objectives of the study.

Placebo

Not used

Assignment

Parallel

Other design features

This research is a multi-method mixed study, that is, the data have been collected, analyzed and integrated with each other with qualitative and quantitative approaches during several stages. In the first stage, the psychosocial support needs of pregnant teenagers are explained with the qualitative approach of guided content analysis. In the second stage, formulation of the intervention based on the solutions extracted from the qualitative stage and a review of the texts, prioritization and consensus on the selection of the intervention to promote psychosocial support provided based on the views of the experts using the nominal group method. And after analyzing the quantitative data and qualitatively, their results will be compared and combined.

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Research Ethics Committees of Ahvaz Jondishapur University of Medical Sciences

Street address

Ahvaz Jondishapur University of Medical Sciences; Golestan street

City

Ahvaz

Province

Khouzestan

Postal code

15794 61357
Approval date: 2023-06-03, 1402/03/13
Ethics committee reference number: IR.AJUMS.REC.1402.140

Health conditions studied

1

Description of health condition studied: Social support
ICD-10 code
ICD-10 code description

2

Description of health condition studied: Perceived Stress
ICD-10 code: Z73.3
ICD-10 code description: Stress, not elsewhere classified

3

Description of health condition studied: Depression
ICD-10 code: F53.1
ICD-10 code description: Severe mental and behavioural disorders associated with the puerperium, not elsewhere classified

4

Description of health condition studied: anger expression
ICD-10 code: R45.4
ICD-10 code description: Irritability and anger

Primary outcomes

1

Description: Social support
Timepoint: Before intervention and after the sessions are completed and one month after the intervention
Method of measurement: Vaux social support

2

Description: Spielberger anger expression scale score
Timepoint: Before intervention and after the sessions are completed and one month after the intervention
Method of measurement: Spielberger anger expression scale

3

Description: Depression
Timepoint: Before intervention and after the sessions are completed and one month after the intervention
Method of measurement: Depression Edinburgh EDS

4

Description: Perceived Stress
Timepoint: Before intervention and after the sessions are completed and one month after the intervention
Method of measurement: Perceived Stress Scale

5

Description: Pregnancy outcome in mental health
Timepoint: Before intervention and after the sessions are completed and one month after the intervention
Method of measurement: Perceived Stress Scale-Depression Edinburgh EDS-Spielberger anger expression scale score

Secondary outcomes

empty

Intervention groups

1

Description: Intervention group: In the intervention group, participants will receive 4-6 training sessions based on psychosocial support. Depending on the content, the number of sessions may vary. Group sessions of 4 to 10 people will be offered during pregnancy.
Category: Behavior

2

Description: Control group: In the control group, only routine supportive care will be provided by the researcher.
Category: Lifestyle

Recruitment centers

1

Recruitment center: Name of recruitment center

Health care centers under the supervision of Ahvaz Jundishapur University of Medical Sciences

Full name of responsible person

The Officials of health care centers

Street address

Ahvaz Jundishapur University of Medical Sciences, Golestan St. , Ahvaz , Iran

City

Ahvaz

Province

Khouzestan

Postal code

15794 61357

Phone

+98 61 3311 0000

Email

info@ajums.ac.ir

1

Sponsor: Name of organization / entity

Ahvaz University of Medical Sciences

Full name of responsible person

Mehrnoosh Zakerkish

Street address

Ahvaz Jundishapur University of Medical Sciences, Golestan St. , Ahvaz ,

City

Ahvaz

Province

Khouzestan

Postal code

15794 61357

Phone

+98 61 3311 0000

Email

info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Ahvaz University of Medical Sciences
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

Ahvaz University of Medical Sciences

Full name of responsible person

Simin Montazeri

Position

Assistant Professor of Reproductive Health

Latest degree

Ph.D.

Other areas of specialty/work

Reproductive Health

Street address

Ahvaz Jundishapur University of Medical Sciences, Golestan St. , Ahvaz , Iran

City

Ahvaz

Province

Khouzestan

Postal code

15794 61357

Phone

+98 61 3311 0000

Email

mrssiminmontazeri@yahoo.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Ahvaz University of Medical Sciences

Full name of responsible person

Simin Montazeri

Position

Assistant Professor of Reproductive Health

Latest degree

Ph.D.

Other areas of specialty/work

Reproductive Health

Street address

Ahvaz Jundishapur University of Medical Sciences, Golestan St. , Ahvaz , Iran.

City

Ahvaz

Province

Khouzestan

Postal code

15794 61357

Phone

0098 61 3373858

Email

mrssiminmontazeri@yahoo.com

Person responsible for updating data

Contact: Name of organization / entity

Ahvaz University of Medical Sciences

Full name of responsible person

Simin Montazeri

Position

Assistant Professor of Reproductive Health

Latest degree

Ph.D.

Other areas of specialty/work

Reproductive Health

Street address

Ahvaz Jundishapur University of Medical Sciences, Golestan St. , Ahvaz , Iran.

City

Ahvaz

Province

Khouzestan

Postal code

1579461357

Phone

+98 61 3311 0000

Email

mrssiminmontazeri@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD): Yes - There is a plan to make this available
Study Protocol: Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan: Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form: Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report: Undecided - It is not yet known if there will be a plan to make this available
Analytic Code: Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary: Not applicable
Title and more details about the data/document: All data is potentially shareable after de-identifying individuals.
When the data will become available and for how long: starting 9 months after publication
To whom data/document is available: people working in academic institutions
Under which criteria data/document could be used: with previous agreement with the corresponding author
From where data/document is obtainable: email address:yousefi.setareh@gmail.com
What processes are involved for a request to access data/document: email address: yousefi.setareh@gmail.com
Comments

Investigating the effectiveness of an intervention based on psychosocial support compared to standard care on pregnancy outcomes in adolescent pregnancy.