NCT06444581

Brief Summary

This study aims to evaluate the effectiveness of a 12-session cognitive-behavioral transdiagnostic protocol for Spanish children aged 8 to 12 within an educational context, Super Skills for Life. The program, designed to enhance emotional management and social interaction skills, will be delivered in a group format and supplemented with multimedia materials. The study will compare outcomes between an intervention group and a wait-list control group.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,100

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2024

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 5, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

December 9, 2024

Status Verified

December 1, 2024

Enrollment Period

4 months

First QC Date

May 22, 2024

Last Update Submit

December 4, 2024

Conditions

Keywords

Social skillsEmotional skillsPrevention universal programProgram evaluationTransdiagnostic protocolCognitive-behavioral protocolChildhoodChildrenSchoolEducational contextGroup format

Outcome Measures

Primary Outcomes (28)

  • Social Skills Questionnaire (SSQ) (Pupil Version)

    SSQ (Pupil Version) is a social skills assessment measure that focuses on a wide range of social behaviors in children aged 8-18. Scoring the Social Skills Questionnaire (Youth): Scores are rated from 0 (Not true), through 1 (Sometimes true), to 2 (Mostly true). The total score is computed by adding up the scores (0, 1, 2) for each item. Total scores range from 0 to 60. Higher scores on this scale indicate higher social skills in children.

    Baseline

  • Social Skills Questionnaire (SSQ) (Pupil Version)

    SSQ (Pupil Version) is a social skills assessment measure that focuses on a wide range of social behaviors in children aged 8-18. Scoring the Social Skills Questionnaire (Youth): Scores are rated from 0 (Not true), through 1 (Sometimes true), to 2 (Mostly true). The total score is computed by adding up the scores (0, 1, 2) for each item. Total scores range from 0 to 60. Higher scores on this scale indicate higher social skills in children.

    Immediately after the intervention

  • Social Skills Questionnaire (SSQ) (Pupil Version)

    SSQ (Pupil Version) is a social skills assessment measure that focuses on a wide range of social behaviors in children aged 8-18. Scoring the Social Skills Questionnaire (Youth): Scores are rated from 0 (Not true), through 1 (Sometimes true), to 2 (Mostly true). The total score is computed by adding up the scores (0, 1, 2) for each item. Total scores range from 0 to 60. Higher scores on this scale indicate higher social skills in children.

    6 months after the intervention

  • Social Skills Questionnaire (SSQ) (Pupil Version)

    SSQ (Pupil Version) is a social skills assessment measure that focuses on a wide range of social behaviors in children aged 8-18. Scoring the Social Skills Questionnaire (Youth): Scores are rated from 0 (Not true), through 1 (Sometimes true), to 2 (Mostly true). The total score is computed by adding up the scores (0, 1, 2) for each item. Total scores range from 0 to 60. Higher scores on this scale indicate higher social skills in children.

    12 months after the intervention

  • The Positive and Negative Affect Schedule for Children-Short Form (PANAS-C-SF)

    PANAS-C-SF assesses two subscales in children aged 6 to 18 years: positive affect (joyful, lively, happy, energetic, and proud) and negative affect (angry, fearful/scared, afraid, and sad). Responses are rated on a 5-point Likert scale ranging from 1 (very slightly or never) to 5 (very much).

    Baseline

  • The Positive and Negative Affect Schedule for Children-Short Form (PANAS-C-SF)

    PANAS-C-SF assesses two subscales in children aged 6 to 18 years: positive affect (joyful, lively, happy, energetic, and proud) and negative affect (angry, fearful/scared, afraid, and sad). Responses are rated on a 5-point Likert scale ranging from 1 (very slightly or never) to 5 (very much).

    Immediately after the intervention

  • The Positive and Negative Affect Schedule for Children-Short Form (PANAS-C-SF)

    PANAS-C-SF assesses two subscales in children aged 6 to 18 years: positive affect (joyful, lively, happy, energetic, and proud) and negative affect (angry, fearful/scared, afraid, and sad). Responses are rated on a 5-point Likert scale ranging from 1 (very slightly or never) to 5 (very much).

    6 months after the intervention

  • The Positive and Negative Affect Schedule for Children-Short Form (PANAS-C-SF)

    PANAS-C-SF assesses two subscales in children aged 6 to 18 years: positive affect (joyful, lively, happy, energetic, and proud) and negative affect (angry, fearful/scared, afraid, and sad). Responses are rated on a 5-point Likert scale ranging from 1 (very slightly or never) to 5 (very much).

    12 months after the intervention

  • Measured by the Cognitive Emotion Regulation Questionnaire (CERQ-k)

    CERQ-k consists of 36 items that measure nine cognitive coping strategies. Each subscale represents one cognitive coping strategy: Self-blame, Other blame, Acceptance, Planning, Positive refocusing, Rumination or focus on thought, Positive reappraisal, Putting into perspective, and Catastrophizing. The response format of the items is a five-point scale from (almost) never to (almost) always. Each item is rated 1 to 5 points. Minimum value 36 and maximum value 180.

    Baseline

  • Measured by the Cognitive Emotion Regulation Questionnaire (CERQ-k)

    CERQ-k consists of 36 items that measure nine cognitive coping strategies. Each subscale represents one cognitive coping strategy: Self-blame, Other blame, Acceptance, Planning, Positive refocusing, Rumination or focus on thought, Positive reappraisal, Putting into perspective, and Catastrophizing. The response format of the items is a five-point scale from (almost) never to (almost) always. Each item is rated 1 to 5 points. Minimum value 36 and maximum value 180.

    Immediately after the intervention

  • Measured by the Cognitive Emotion Regulation Questionnaire (CERQ-k)

    CERQ-k consists of 36 items that measure nine cognitive coping strategies. Each subscale represents one cognitive coping strategy: Self-blame, Other blame, Acceptance, Planning, Positive refocusing, Rumination or focus on thought, Positive reappraisal, Putting into perspective, and Catastrophizing. The response format of the items is a five-point scale from (almost) never to (almost) always. Each item is rated 1 to 5 points. Minimum value 36 and maximum value 180.

    6 months after the intervention

  • Measured by the Cognitive Emotion Regulation Questionnaire (CERQ-k)

    CERQ-k consists of 36 items that measure nine cognitive coping strategies. Each subscale represents one cognitive coping strategy: Self-blame, Other blame, Acceptance, Planning, Positive refocusing, Rumination or focus on thought, Positive reappraisal, Putting into perspective, and Catastrophizing. The response format of the items is a five-point scale from (almost) never to (almost) always. Each item is rated 1 to 5 points. Minimum value 36 and maximum value 180.

    12 months after the intervention

  • Baseline children's reported anxiety symptoms. Measured by Spence Children's Anxiety Scale Child Report Short (SCAS-C-8)

    SCAS-C-8 measures symptoms severity of the DSMIV anxiety disorders in children. Symptom frequency is recorded on a 3-point Likert scale from 0 (never) to 3 (always). This yields a minimum possible score of 0 and a maximum possible score of 24. Higher scores indicating greater severity of symptoms.

    Baseline

  • Baseline children's reported anxiety symptoms. Measured by Spence Children's Anxiety Scale Child Report Short (SCAS-C-8)

    SCAS-C-8 measures symptoms severity of the DSMIV anxiety disorders in children. Symptom frequency is recorded on a 3-point Likert scale from 0 (never) to 3 (always). This yields a minimum possible score of 0 and a maximum possible score of 24. Higher scores indicating greater severity of symptoms.

    Immediately after the intervention

  • Baseline children's reported anxiety symptoms. Measured by Spence Children's Anxiety Scale Child Report Short (SCAS-C-8)

    SCAS-C-8 measures symptoms severity of the DSMIV anxiety disorders in children. Symptom frequency is recorded on a 3-point Likert scale from 0 (never) to 3 (always). This yields a minimum possible score of 0 and a maximum possible score of 24. Higher scores indicating greater severity of symptoms.

    6 months after the intervention

  • Baseline children's reported anxiety symptoms. Measured by Spence Children's Anxiety Scale Child Report Short (SCAS-C-8)

    SCAS-C-8 measures symptoms severity of the DSMIV anxiety disorders in children. Symptom frequency is recorded on a 3-point Likert scale from 0 (never) to 3 (always). This yields a minimum possible score of 0 and a maximum possible score of 24. Higher scores indicating greater severity of symptoms.

    12 months after the intervention

  • Measured by Mood and Feelings Questionnaire - Short Version (MFQS)

    It assess depressive symptoms experienced in the past two weeks. The MFQS provides an overall score (minimum value 0, maximum value 26). Higher scores indicate more severe symptoms.

    Baseline

  • Measured by Mood and Feelings Questionnaire - Short Version (MFQS)

    It assess depressive symptoms experienced in the past two weeks. The MFQS provides an overall score (minimum value 0, maximum value 26). Higher scores indicate more severe symptoms.

    Immediately after the intervention

  • Measured by Mood and Feelings Questionnaire - Short Version (MFQS)

    It assess depressive symptoms experienced in the past two weeks. The MFQS provides an overall score (minimum value 0, maximum value 26). Higher scores indicate more severe symptoms.

    6 months after the intervention

  • Measured by Mood and Feelings Questionnaire - Short Version (MFQS)

    It assess depressive symptoms experienced in the past two weeks. The MFQS provides an overall score (minimum value 0, maximum value 26). Higher scores indicate more severe symptoms.

    12 months after the intervention

  • Baseline level of physical and emotional well-being reported by children as measured by the KidKINDL_children questionnaire.

    The KidKINDL\_children measures assess physical and emotional well-being of children aged 7 to 13 years across six dimensions: physical well-being, psychological well-being, self-esteem, family, social relationships, and school. Children rate each item on a 5-point Likert scale: never (1), almost never (2), sometimes (3), almost always (4), and always (5). The total score is calculated by adding the scores for each dimension (range for each dimension: 4 to 20 points). Higher scores on each subscale and on the total scale indicate lower symptoms in children.

    Baseline

  • Level of physical and emotional well-being reported by children as measured by the KidKINDL_children questionnaire.

    The KidKINDL\_children measures assess physical and emotional well-being of children aged 7 to 13 years across six dimensions: physical well-being, psychological well-being, self-esteem, family, social relationships, and school. Children rate each item on a 5-point Likert scale: never (1), almost never (2), sometimes (3), almost always (4), and always (5). The total score is calculated by adding the scores for each dimension (range for each dimension: 4 to 20 points). Higher scores on each subscale and on the total scale indicate lower symptoms in children.

    Immediately after the intervention

  • Level of physical and emotional well-being reported by children as measured by the KidKINDL_children questionnaire.

    The KidKINDL\_children measures assess physical and emotional well-being of children aged 7 to 13 years across six dimensions: physical well-being, psychological well-being, self-esteem, family, social relationships, and school. Children rate each item on a 5-point Likert scale: never (1), almost never (2), sometimes (3), almost always (4), and always (5). The total score is calculated by adding the scores for each dimension (range for each dimension: 4 to 20 points). Higher scores on each subscale and on the total scale indicate lower symptoms in children.

    6 months after the intervention

  • Level of physical and emotional well-being reported by children as measured by the KidKINDL_children questionnaire.

    The KidKINDL\_children measures assess physical and emotional well-being of children aged 7 to 13 years across six dimensions: physical well-being, psychological well-being, self-esteem, family, social relationships, and school. Children rate each item on a 5-point Likert scale: never (1), almost never (2), sometimes (3), almost always (4), and always (5). The total score is calculated by adding the scores for each dimension (range for each dimension: 4 to 20 points). Higher scores on each subscale and on the total scale indicate lower symptoms in children.

    12 months after the intervention

  • 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.

    Baseline

  • 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.

    Immediately after the intervention

  • 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.

    6 months after the intervention

  • 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.

    12 months after the intervention

Secondary Outcomes (8)

  • The Child-Adolescent Perfectionism Scale (CAPS-S)

    Baseline

  • The Child-Adolescent Perfectionism Scale (CAPS-S)

    Immediately after the intervention

  • The Child-Adolescent Perfectionism Scale (CAPS-S)

    6 months after the intervention

  • The Child-Adolescent Perfectionism Scale (CAPS-S)

    12 months after the intervention

  • Baseline level of physical and emotional well-being reported by parents as measured by the Kid_KiddoKINDL-R questionnaire

    Baseline

  • +3 more secondary outcomes

Study Arms (2)

Group experimental

EXPERIMENTAL

Super Skills intervention group: multimedia material version The Super Skills program will be administered following the manual of the intervention by a trained therapist, as described in the section of intervention/ treatment and will be enriched with multimedia material that the implementer will project at various moments of the sessions. Super Skills Structured and manualized intervention with a manual for the therapist and a workbook for the children. The intervention will be administered by Super Skills-trained clinical psychologists. Sessions will take place once a week for twelve weeks, with each session lasting approximately fifty minutes. The program includes emotional education and social skills training. These contents are learned through playful exercises, activities, readings and role-playing. The intervention modality will be face-to-face.

Behavioral: Super Skills Schools

Group without any intervention

NO INTERVENTION

Participants in the wait-list group will receive no psychological intervention during the twelve-week duration of the Super Skills program. Families will be informed that children in this group will receive the intervention once the posttest is completed.

Interventions

Super Skills Structured and manualized intervention with a manual for the therapist and a workbook for the children. The intervention will be administered by Super Skills-trained clinical psychologists. Sessions will take place once a week for twelve weeks, with each session lasting approximately fifty minutes. The program includes emotional education and social skills training. These contents are learned through playful exercises, activities, readings and role-playing. The intervention modality will be face-to-face.

Group experimental

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 8 to 12 years.
  • Be Spanish-speaking.
  • Accepting informed consent to participate in the study.

You may not qualify if:

  • Intellectual disability, behavioral symptoms or autistic spectrum symptoms whose severity prevented the continuation of treatment.
  • Current psychological or pharmacological treatment for anxiety and/or depression.
  • Not accepting or revoking informed consent to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Health Psychology. Miguel Hernandez University of Elche

Elche, Alicante, 03203, Spain

Location

Related Publications (5)

  • Orgiles M, Fernandez-Martinez I, Espada JP, Morales A. Spanish version of Super Skills for Life: short- and long-term impact of a transdiagnostic prevention protocol targeting childhood anxiety and depression. Anxiety Stress Coping. 2019 Nov;32(6):694-710. doi: 10.1080/10615806.2019.1645836. Epub 2019 Jul 23.

  • Fernandez-Martinez I, Orgiles M, Morales A, Espada JP, Essau CA. One-Year follow-up effects of a cognitive behavior therapy-based transdiagnostic program for emotional problems in young children: A school-based cluster-randomized controlled trial. J Affect Disord. 2020 Feb 1;262:258-266. doi: 10.1016/j.jad.2019.11.002. Epub 2019 Nov 4.

  • Melero S, Morales A, Espada JP, Mendez X, Orgiles M. Effectiveness of Group vs. Individual Therapy to Decrease Peer Problems and Increase Prosociality in Children. Int J Environ Res Public Health. 2021 Apr 9;18(8):3950. doi: 10.3390/ijerph18083950.

  • Essau CA, Sasagawa S, Jones G, Fernandes B, Ollendick TH. Evaluating the real-world effectiveness of a cognitive behavior therapy-based transdiagnostic program for emotional problems in children in a regular school setting. J Affect Disord. 2019 Jun 15;253:357-365. doi: 10.1016/j.jad.2019.04.036. Epub 2019 Apr 16.

  • Yoga Ratnam KK, Nik Farid ND, Yakub NA, Dahlui M. The Effectiveness of the Super Skills for Life (SSL) Programme in Promoting Mental Wellbeing among Institutionalised Adolescents in Malaysia: An Interventional Study. Int J Environ Res Public Health. 2022 Jul 30;19(15):9324. doi: 10.3390/ijerph19159324.

Related Links

MeSH Terms

Conditions

Social SkillsEmotional RegulationDepressionAnxiety DisordersMood Disorders

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorSelf-ControlBehavioral SymptomsMental Disorders

Study Officials

  • Mireia Orgilés Amorós, professor

    Miguel Hernadez University of Elche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Participants who meet the inclusion criteria and undergo the full baseline assessment will be assigned to the intervention group condition or to the wait-list control (WLC) group. Children assigned to the intervention condition will receive the twelve-week intervention. Participants in the WLC group will not receive any psychological intervention during the twelve-week program. Children and parents in all groups will complete the same set of measures at approximately the same time (pre-test and post-twelve weeks). Children in the WLC group will receive the intervention after the follow-up visit is completed.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 22, 2024

First Posted

June 5, 2024

Study Start

January 8, 2024

Primary Completion

May 15, 2024

Study Completion

May 1, 2025

Last Updated

December 9, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
Starting after finishing all analysis and publication.
Access Criteria
Upon request and verification by the principal investigator to consult the available data. The use of the data for distribution in any format is not permitted.

Locations