- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07492082
Executive Functions and Emotional Intelligence in Pregnant Adolescents (EFAEIPA)
Emotional Intelligence and Executive Functions in Pregnant Adolescents Living in Rural Areas: a Study of a Psychological Intervention
Teenage pregnancy is a major global public health issue and is associated with a range of psychosocial, emotional, and developmental challenges. Adolescence is a critical stage of development characterized by the ongoing maturation of executive functions, including inhibitory control, emotional regulation, working memory, planning, and decision-making. These cognitive and emotional processes are essential for adaptive functioning and psychological well-being. However, when pregnancy occurs during adolescence, young women may face additional stressors, such as social stigma, limited social support, disruption of education, and economic vulnerability, which can negatively affect their mental health and coping abilities.
Previous research has shown that pregnant adolescents may experience higher levels of emotional distress, anxiety, and depressive symptoms compared to pregnant adult women. Furthermore, difficulties in executive functions and emotional regulation may influence adolescents' ability to manage stress, regulate their emotions, and make adaptive decisions during pregnancy and the transition to motherhood. Therefore, interventions that strengthen emotional and cognitive self-regulation may play an important role in improving the psychological adjustment and well-being of pregnant adolescents.
The present study aims to evaluate the effectiveness of an intervention designed to improve emotional intelligence and executive functions in pregnant adolescents. The program seeks to promote greater emotional understanding and self-regulation, as well as to support adolescents in coping with the psychological challenges associated with pregnancy.
Participants will complete standardized psychological assessments before and after the intervention to evaluate potential changes in executive functioning and emotional well-being.
By assessing the impact of an intervention on emotional intelligence and executive functions, this study seeks to contribute to the development of evidence-based strategies to improve the mental health and psychosocial outcomes of pregnant adolescents. The results may provide valuable information for healthcare professionals, psychologists, and public health programs seeking to support adolescent mothers and promote healthier developmental trajectories during pregnancy and early motherhood.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Adolescent pregnancy remains a significant public health concern worldwide and is associated with a variety of social, emotional, and psychological challenges. During adolescence, individuals experience important developmental changes involving cognitive, emotional, and social processes. In particular, adolescence is characterized by the progressive development of executive functions and emotional regulation abilities, which play a critical role in decision-making, behavioral control, and adaptive functioning.
Executive functions refer to a set of higher-order cognitive processes that support goal-directed behavior and the ability to regulate thoughts, emotions, and actions. These processes include inhibitory control, working memory, cognitive flexibility, planning, organization, and self-monitoring. The development of these cognitive abilities is closely associated with the maturation of the prefrontal cortex, which continues to develop throughout adolescence and early adulthood.
When pregnancy occurs during adolescence, young individuals may face additional psychosocial stressors that can affect their emotional well-being and psychological adjustment. Pregnant adolescents often encounter challenges such as social stigma, educational disruption, economic difficulties, and changes in interpersonal relationships. These stressors may increase vulnerability to emotional distress, anxiety, and depressive symptoms.
Previous research has shown that adolescent mothers may present higher levels of emotional vulnerability compared to adult pregnant women. Emotional difficulties during pregnancy may negatively influence maternal well-being, interpersonal relationships, and adaptation to motherhood. Therefore, identifying psychological factors that may support better emotional adjustment during adolescent pregnancy is an important area of research.
Emotional intelligence and emotional regulation have been identified as protective factors that can contribute to improved psychological adaptation during stressful life events. Emotional intelligence refers to the ability to recognize, understand, and manage one's own and others' emotions. Adolescents with greater emotional regulation skills may be better able to cope with stress, manage interpersonal conflicts, and make adaptive decisions in difficult situations.
In addition to emotional regulation, executive functioning plays a key role in self-regulation of behavior and decision-making processes. Difficulties in executive functioning can affect adolescents' ability to plan, control impulses, anticipate consequences, and regulate emotional responses. These cognitive processes are especially relevant in the context of adolescent pregnancy, where individuals must adapt to major life changes and new responsibilities.
Psychoeducational interventions designed to strengthen emotional intelligence and executive functioning have shown promising results in improving adolescents' psychological well-being. These interventions typically focus on developing emotional awareness, teaching emotional regulation strategies, strengthening problem-solving skills, and promoting adaptive coping strategies.
The present study aims to design, implement, and evaluate the effect of a psychological intervention program on executive functioning and emotional intelligence in pregnant adolescents aged 14 to 18 years residing in the Mexicali Valley. The intervention will consist of a structured program delivered through group sessions that focus on emotional awareness, emotional regulation strategies, stress management, decision-making skills, and problem-solving skills related to pregnancy and early motherhood.
The program will include activities such as guided discussions, emotional reflection exercises, skill-building activities, and group interactions that encourage participants to share experiences and develop supportive relationships. The program aims to provide adolescents with practical tools to better understand their emotions, regulate their emotional responses, and manage the challenges associated with pregnancy and the transition to motherhood.
To evaluate the results of the intervention, participants will complete standardized psychological assessments before the intervention (baseline) and after completing the program. These assessments will allow researchers to evaluate possible changes in executive functioning, emotional regulation, emotional intelligence, and depressive symptoms.
To obtain a comprehensive assessment of the psychological variables included in this study, participants will complete a series of standardized psychological instruments. Executive functioning will be assessed using two complementary measures. The Battery of Executive Functions and Frontal Lobes - Third Edition (BANFE-3) will be used to assess executive processes associated with frontal lobe functioning, including planning, inhibitory control, working memory, and cognitive flexibility. In addition, the self-report version of the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) will assess behavioral manifestations of executive functioning in everyday contexts, including aspects such as inhibition, emotional regulation, and cognitive organization.
Emotional intelligence will be assessed using the BarOn Emotional Quotient Inventory: Youth Version (EQ-i:YV), which measures emotional and social competencies in adolescents, including intrapersonal and interpersonal skills, adaptability, stress management, and overall mood. Psychosocial risk indicators that commonly occur during adolescence will be explored using the Adolescent Self-Descriptive Inventory (ASDI), which identifies behavioral, emotional, and social factors associated with psychosocial vulnerability.
In addition, mental health status will be assessed using standardized measures of anxiety and depressive symptoms. Anxiety will be assessed using the Children's Manifest Anxiety Scale, Second Edition (CMAS-R-2), which assesses different manifestations of anxiety in children and adolescents. Depressive symptoms associated with the perinatal period will be assessed using the Edinburgh Postnatal Depression Scale (EPDS), a widely used instrument designed to identify depressive symptoms during pregnancy and the postpartum period.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Be in the first or second trimester of pregnancy at the time of the procedure.
- Be between the ages of 14 and 18.
- Have a basic level of literacy (be able to read and write).
- Receive prenatal medical care.
- Sign the informed consent form, both the patient and an adult family member.
Exclusion Criteria:
- Serious medical conditions that limit your participation and/or continued participation in the study.
- Neurological or psychiatric conditions (other than mild to moderate depression and anxiety) that have an impact on executive functioning and emotional intelligence on their own.
- No interest or availability to participate in the entire program.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: single group
Pregnant adolescents aged 14 to 18 residing in the Mexicali Valley who participate in a group psychological intervention program aimed at improving executive functioning and emotional intelligence through psychoeducation sessions.
|
A group psychological intervention program based on psychoeducation, designed for pregnant adolescents living in the Mexicali Valley.
The program consists of four 40-minute sessions, held once a month over a four-month period, and focuses on developing skills in emotion recognition, planning, organization, emotional regulation, and decision-making.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Inhibitory control
Time Frame: Pre- and post-assessment, after 4 months
|
Stroop test, will be measured from the standardized executive function test BANFE, using accuracy of response, stroop type error, no-Stroop errors, and time, Total score is transformed to normalized points 0-19 (with a mean of 10 ±3 SD, 4-6 low, 14-19 high performance).
|
Pre- and post-assessment, after 4 months
|
|
Planning
Time Frame: Pre- and post-assessment, after 4 months
|
Tower of Hanoi, using number of movements, and time, will be measured by calculating EF quotients from the standardized test BANFE.
Total score is transformed to normalized points 0-19 (with a mean of 10 ±3 SD, 4-6 low, 14-19 high performance).
|
Pre- and post-assessment, after 4 months
|
|
Executive Functioning
Time Frame: Pre- and post-assessment, after 4 months
|
Inventory for the Behavioral Assessment of Executive Functioning in its self-report version (BRIEF-2) is a standardized instrument that assesses executive functioning in adolescents through their perception of their own behavior in daily life. It analyzes behavioral, emotional, and cognitive regulation, allowing for the identification of difficulties in planning, self-control, and organization. The self-report version of BRIEF-2 takes approximately 10 to 15 minutes to complete, followed by a brief scoring and interpretation process by the evaluator. The BRIEF has been adapted and validated in Spanish-speaking and Mexican populations, showing adequate validity and reliability indices. For example, studies conducted with Mexican populations report high internal consistency (α = .939) and an adequate factorial structure of the instrument, which supports its use for assessing executive functions in similar cultural contexts. |
Pre- and post-assessment, after 4 months
|
|
Emotional Intelligence
Time Frame: Pre- and post-assessment, after 4 months
|
BarOn Emotional Intelligence Inventory: Youth Version. EQ-i:YV (R. Bar-On, J. D. A. Parke, 2000) is a psychometric inventory that assesses emotional intelligence in children and adolescents using a self-report questionnaire. It analyzes intrapersonal and interpersonal skills, stress management, adaptability, and general mood, providing insight into the socio-emotional development of the person being assessed. Has an approximate application time of 20 to 30 minutes. Raw scores are converted to standard scores (mean 100, standard deviation 15) Standard Score > 120 Very high emotional capacity (positively atypical) < 80 Very low emotional capacity (intervention required) |
Pre- and post-assessment, after 4 months
|
|
Identify adolescent risks
Time Frame: Pre- and post-assessment, after 4 months
|
Self-descriptive inventory for adolescents (IADA) (Lucio-Gómez et al., 2010) It was developed with the aim of providing a valid and reliable tool to assist in the assessment of psychological problems, both in terms of early detection of risk factors in adolescents' lives and the identification of emotional problems. It was designed to be useful primarily in clinical settings, but also in educational settings, as well as in primary and secondary intervention processes. The Adolescent Self-Descriptive Inventory (IADA) consists of 168 forced-choice items (YES-NO). T-score (with a mean of 50 and a standard deviation of 10) When analyzing the individual dimensions (Family, Social, School, Personal, and Health), the following T-scores are used: T < 60: Within the normal range (no significant risk). T 60-69: Moderate risk (indicator of problems in that specific area). T ≥ 70: High risk (significant problem reported by the adolescent) has an approximate application time of 30 to 40 minutes. |
Pre- and post-assessment, after 4 months
|
|
Manifest Anxiety
Time Frame: Pre- and post-assessment, after 4 months
|
Revised Children's Manifest Anxiety Scale (CMAS-R-2) (Reynolds, 2008) It is a self-report instrument consisting of 49 items designed to assess the degree and nature of anxiety in children.
The child only answers the questions with yes or no.
Scoring is simple.
The total scores give the Total Anxiety Index but also provide five additional scores: Physiological Anxiety, Worries, Social Anxiety, Defensiveness, and an Index of Inconsistent Responses.
This instrument is very useful for assessing children/adolescents with problems such as academic stress, test anxiety, family conflicts, drug addiction, disruptive behavior, results Typically analyzed using T-scores, where a total score >60 indicates high impairment.
It covers physiological anxiety, worry, social anxiety, and includes defensiveness/inconsistency indices.
personality problems, etc. has an approximate application time of 10 to 15 minutes.
|
Pre- and post-assessment, after 4 months
|
|
Perinatal Depression
Time Frame: Pre- and post-assessment, after 4 months
|
The Edinburgh Postnatal Depression Scale (EPDS) The scale consists of 10 items that assess emotional and cognitive symptoms associated with perinatal depression experienced over the previous seven days. Each item is scored on a 4-point Likert scale (0-3), with total scores ranging from 0 to 30, where higher scores indicate greater severity of depressive symptoms. The EPDS evaluates symptoms such as sadness, loss of interest or pleasure, anxiety, feelings of guilt, and sleep disturbances related to mood. Validation studies in Mexico recommended lower cut-offs: 11/12 for women within the first 4 weeks postpartum, and 7/8 for 4 to 13 weeks postpartum. 13 or more (13+): A score of 13 or higher is commonly used to indicate a high probability of depressive illness of varying severity. 10-12: Some guidelines suggest that scores of 10 or greater indicate the possibility of depression. 0-9 Scores in this range suggest that the mother is less likely to be suffering from a significant. |
Pre- and post-assessment, after 4 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MP/2026MMPG
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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