Super Skills for Life Effectiveness in the Online Modality

Sponsor

Universidad Miguel Hernandez de Elche (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05589090

Collaborator

Ministerio de Economía y Competitividad, Spain (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study aims to evaluate the effectiveness of the transdiagnostic program Super Skills for Life (SSL). This protocol targets children aged 8 to 12 with emotional problems (anxiety, depression, low self-esteem, and lack of social skills). SSL consists of eight sessions targeting common risk factors for internalizing disorders such as cognitive distortions, avoidance, emotional management, low self-esteem, social skills deficits, and coping strategies. The present research focuses on assessing the effectiveness of SSL applied online (through a virtual platform).

Condition or Disease	Intervention/Treatment	Phase
Depressive Disorder Depressive Symptoms Anxiety Disorders Anxiety Disorders and Symptoms Mood Disorders Child Mental Disorder Emotional Disorder	Behavioral: Super Skills for Life program	N/A

Detailed Description

After selecting the children based on the online questionnaires completed by the parents (preintervention assessment) and inclusion/exclusion criteria, they were randomly allocated to the conditions of the intervention group and the wait-list control group. Parents and children from both groups completed the same measures at baseline, post-treatment, and 12 months follow-up. Children in the experimental group received the SSL program by the virtual platform.

The objective of the study is to evaluate the benefits of the Super Skills for Life protocol applied online. For this purpose, the researchers will test to what extent the experimental group decreases its anxiety symptoms, anxiety impairment, depressive symptoms, behavioral problems, hyperactivity/inattention, and peer relationship problems, and increase its self-esteem and prosocial behaviors, compared to the control group.

In conclusion, the purpose of the study is to explore whether SSL implemented online can be a cost-effective psychological intervention to prevent emotional problems in Spanish children.

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Study participants who met the inclusion criteria were randomly assigned to the experimental and control groups. The control group did not receive any intervention during the eight-week duration of the program. However, both groups underwent pretest and posttest assessments. Children assigned to the control group will receive the intervention after the 12-month follow-up assessment.Study participants who met the inclusion criteria were randomly assigned to the experimental and control groups. The control group did not receive any intervention during the eight-week duration of the program. However, both groups underwent pretest and posttest assessments. Children assigned to the control group will receive the intervention after the 12-month follow-up assessment.

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Adaptación y evaluación Del Programa transdiagnóstico Super Skills for Life Aplicado Online Para niños Con Problemas Interiorizados

Actual Study Start Date :

Oct 1, 2017

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group Super Skills for Life intervention	Behavioral: Super Skills for Life program Children in the experimental group received eight sessions of the Super Skills for Life protocol. The intervention was implemented using a structured manual for the therapist and a workbook for the children [Orgilés, M., Espada, J.P., Ollendick, T.H. & Essau, C. (2022). Programa Super Skills. Manual del aplicador. Elche, ES: Universidad Miguel Hernández]. The intervention was administered via an online virtual platform for eight weeks, with each session lasting approximately one hour.
No Intervention: Wait-list group Children in this group did not receive any phycological (public or private) intervention during the eight-week duration of the SSL program. They were informed that children in this group will receive the intervention once the follow-up visit is completed.

Arm

Intervention/Treatment

Experimental: Intervention group

Super Skills for Life intervention

Behavioral: Super Skills for Life program

Children in the experimental group received eight sessions of the Super Skills for Life protocol. The intervention was implemented using a structured manual for the therapist and a workbook for the children [Orgilés, M., Espada, J.P., Ollendick, T.H. & Essau, C. (2022). Programa Super Skills. Manual del aplicador. Elche, ES: Universidad Miguel Hernández]. The intervention was administered via an online virtual platform for eight weeks, with each session lasting approximately one hour.

No Intervention: Wait-list group

Children in this group did not receive any phycological (public or private) intervention during the eight-week duration of the SSL program. They were informed that children in this group will receive the intervention once the follow-up visit is completed.

Outcome Measures

Primary Outcome Measures

Change from baseline depression symptoms to immediately after the intervention [1 year after the intervention]
Measured by the Mood and Feelings Questionnaire (MFQ-C; short version), a screening tool for depression in children aged 6-17 years. Children must report their feelings and behaviors over the previous 2 weeks. The sum of all items provides a total measure of depression (score range: 0-26), and the higher this score is, the more severe the symptoms are.
Depression symptoms at 1 year [1 year after the intervention]
Measured by the Mood and Feelings Questionnaire (MFQ-C; short version), a screening tool for depression in children aged 6-17 years. Children must report their feelings and behaviors over the previous 2 weeks. The sum of all items provides a total measure of depression (score range: 0-26), and the higher this score is, the more severe the symptoms are.
Change from baseline parent-reported depression to immediately after the intervention [baseline and immediately after the intervention]
Measured by the Mood and Feelings Questionnaire (MFQ-P; short version), a screening tool for depression in children aged 6-17 years. Parents must inform about their children's feelings and behaviors over the previous 2 weeks. The sum of all items provides a total measure of depression (score range: 0-26), and the higher this score is, the more severe the symptoms are.
Parent-reported depression at 1 year [1 year after the intervention]
Measured by the Mood and Feelings Questionnaire (MFQ-P; short version), a screening tool for depression in children aged 6-17 years. Parents must inform about their children's feelings and behaviors over the previous 2 weeks. The sum of all items provides a total measure of depression (score range: 0-26), and the higher this score is, the more severe the symptoms are.
Change from baseline children's reported anxiety symptoms to immediately after the intervention [baseline and immediately after the intervention]
Measured by Spence Children's Anxiety Scale Child Report (SCAS; short version). SCAS measures symptoms severity of the DSM-IV anxiety disorders in children (subscales: total, panic and agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, social phobia, separation anxiety, and specific fears). This yields a minimum possible score of 0 and a maximum possible score of 24. Higher scores indicate greater severity of symptoms
Change from baseline parent-reported anxiety symptoms to immediately after the intervention [baseline and immediately after the intervention]
Measured by Spence Children's Anxiety Scale Parent Report (SCAS-P; short version). SCAS-P measures symptoms severity of the DSM-IV anxiety disorders in children (subscales: total, panic and agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, social phobia, separation anxiety, and specific fears). This yields a minimum possible score of 0 and a maximum possible score of 24. Higher scores indicate greater severity of symptoms.
Children's reported anxiety symptoms at 1 year [1 year after the intervention]
Measured by Spence Children's Anxiety Scale Child Report (SCAS; short version). SCAS measures symptoms severity of the DSM-IV anxiety disorders in children (subscales: total, panic and agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, social phobia, separation anxiety, and specific fears). This yields a minimum possible score of 0 and a maximum possible score of 24. Higher scores indicate greater severity of symptoms
Parent-reported anxiety at 1 year [1 year after the intervention]
Measured by Spence Children's Anxiety Scale Parent Report (SCAS-P; short version). SCAS-P measures symptoms severity of the DSM-IV anxiety disorders in children (subscales: total, panic and agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, social phobia, separation anxiety, and specific fears). This yields a minimum possible score of 0 and a maximum possible score of 24. Higher scores indicate greater severity of symptoms.
Change from baseline children's reported psychological adjustment to immediately after the intervention [baseline and immediately after the intervention]
Measured by Strengths and Difficulties Questionnaire Child Report (SDQ). It was designed to measure children's overall difficulties (minimum value 0 and maximum value 40) and positive attributes across five subscales (minimum value 0 and maximum value 10): Emotional symptoms (e.g., anxiety and depression), Conduct problems, Hyperactivity/Inattention, Peer relationships (difficulties), and Pro-social behavior. Higher scores indicate higher levels of difficulties, except on the prosocial subscale, where higher scores reflect a more positive attribute.
Change from baseline parent-reported psychological adjustment to immediately after the intervention [baseline and immediately after the intervention]
Measured by Strengths and Difficulties Questionnaire Parental Report (SDQ-P). It was designed to measure children's overall difficulties (minimum value 0 and maximum value 40) and positive attributes across five subscales (minimum value 0 and maximum value 10): Emotional symptoms (e.g., anxiety and depression), Conduct problems, Hyperactivity/Inattention, Peer relationships (difficulties), and Pro-social behavior. Higher scores indicate higher levels of difficulties, except on the prosocial subscale, where higher scores reflect a more positive attribute.
Children's reported psychological adjustment at 1 year [1 year after the intervention]
Measured by Strengths and Difficulties Questionnaire Child Report (SDQ). It was designed to measure children's overall difficulties (minimum value 0 and maximum value 40) and positive attributes across five subscales (minimum value 0 and maximum value 10): Emotional symptoms (e.g., anxiety and depression), Conduct problems, Hyperactivity/Inattention, Peer relationships (difficulties), and Pro-social behavior. Higher scores indicate higher levels of difficulties, except on the prosocial subscale, where higher scores reflect a more positive attribute.
Parent-reported psychological adjustment at 1 year [1 year after the intervention]
Measured by Strengths and Difficulties Questionnaire Parental Report (SDQ-P). It was designed to measure children's overall difficulties (minimum value 0 and maximum value 40) and positive attributes across five subscales (minimum value 0 and maximum value 10): Emotional symptoms (e.g., anxiety and depression), Conduct problems, Hyperactivity/Inattention, Peer relationships (difficulties), and Pro-social behavior. Higher scores indicate higher levels of difficulties, except on the prosocial subscale, where higher scores reflect a more positive attribute.

Secondary Outcome Measures

Change from baseline self-concept to immediately after the intervention [baseline and immediately after the intervention]
Measured by the Self-Concept Form 5 (AF-5). It measures global satisfaction with self-concept (minimum value 0 and maximum value 120) and five dimensions (minimum value 0 and maximum value 24): Social (performance in social relationships); Academic/Professional (student/worker role); Emotional (perception of emotional state in general and in specific situations); Family (participation and integration into the family unit); and Physical self-concept (appearance and physical condition). Higher scores indicate greater satisfaction with self-image.
Children's self-concept at 1 year [1 year after the intervention]
Measured by the Self-Concept Form 5 (AF-5). It measures global satisfaction with self-concept (minimum value 0 and maximum value 120) and five dimensions (minimum value 0 and maximum value 24): Social (performance in social relationships); Academic/Professional (student/worker role); Emotional (perception of emotional state in general and in specific situations); Family (participation and integration into the family unit); and Physical self-concept (appearance and physical condition). Higher scores indicate greater satisfaction with self-image.
Change from baseline social worries to immediately after the intervention [baseline and immediately after the intervention]
Measured by the Social Worries Questionnaire for pupils (SWQ-PU). It evaluates children's worries in different social situations. In general, the higher the score, the more severe the symptomatology.
Children's social worries at 1 year [1 year after the intervention]
Measured by the Social Worries Questionnaire for pupils (SWQ-PU). It evaluates children's worries in different social situations. In general, the higher the score, the more severe the symptomatology.

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Children aged 8-12
Presenting subclinical symptoms of emotional problems (anxiety, depression)
Speaking, reading, writing, and understanding Spanish.
Not receiving psychological or pharmacological treatment for emotional and/or behavioral problems

Exclusion Criteria:

Had a psychiatric diagnosis already established
Presenting a severe developmental disorder (intellectual disability, autism spectrum disorder, etc).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidad Miguel Hernández de Elche	Elche	Alicante	Spain	03202

Sponsors and Collaborators

Universidad Miguel Hernandez de Elche
Ministerio de Economía y Competitividad, Spain

Investigators

Principal Investigator: Silvia Melero, PhD, Universidad Miguel Hernández de Elche
Study Director: Mireia Orgilés, Professor, Universidad Miguel Hernández de Elche
Study Director: José Pedro Espada, Professor, Universidad Miguel Hernández de Elche