Clinical trial NCT06444581: Effectiveness of the Universal Prevention Program Super Skills for Life in Schools
Official title: Prevention of Emotional Problems in Spanish School Children Aged 8 to 12 Years Old: Evaluation of the Super Skills for Life Program
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Social Skills
Perfectionism
Self Esteem
Positive Affect
Negative Affect
Emotion Regulation
Depressive Symptoms
Anxiety Symptoms
Mood Disorders
Emotional Intelligence
Keywords: Social skills
Emotional skills
Prevention universal program
Program evaluation
Transdiagnostic protocol
Cognitive-behavioral protocol
Childhood
Children
School
Educational context
Group format
Lead sponsor: Universidad Miguel Hernandez de Elche
Sponsor class: OTHER
First posted: 2024-06-05
Enrollment: 1100
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Detailed description: A 2 x 4 factorial design will be employed, with the intervention condition (intervention or waiting list) as the intergroup factor and the evaluation phase (pretest, posttest, 6-month follow-up, and 12-month follow-up) as the intragroup factor. Both parents and children will complete the same assessments at baseline, post-treatment, and follow-up stages. The researchers will analyze the changes in emotional and social variables from pre- to post-assessment in children who participate in the program.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Social Skills Questionnaire (SSQ) (Pupil Version)
timeFrame: Baseline
measure: Social Skills Questionnaire (SSQ) (Pupil Version)
timeFrame: Immediately after the intervention
measure: Social Skills Questionnaire (SSQ) (Pupil Version)
timeFrame: 6 months after the intervention
measure: Social Skills Questionnaire (SSQ) (Pupil Version)
timeFrame: 12 months after the intervention
measure: The Positive and Negative Affect Schedule for Children-Short Form (PANAS-C-SF)
timeFrame: Baseline
measure: The Positive and Negative Affect Schedule for Children-Short Form (PANAS-C-SF)
timeFrame: Immediately after the intervention
measure: The Positive and Negative Affect Schedule for Children-Short Form (PANAS-C-SF)
timeFrame: 6 months after the intervention
measure: The Positive and Negative Affect Schedule for Children-Short Form (PANAS-C-SF)
timeFrame: 12 months after the intervention
measure: Measured by the Cognitive Emotion Regulation Questionnaire (CERQ-k)
timeFrame: Baseline
measure: Measured by the Cognitive Emotion Regulation Questionnaire (CERQ-k)
timeFrame: Immediately after the intervention
measure: Measured by the Cognitive Emotion Regulation Questionnaire (CERQ-k)
timeFrame: 6 months after the intervention
measure: Measured by the Cognitive Emotion Regulation Questionnaire (CERQ-k)
timeFrame: 12 months after the intervention
measure: Baseline children's reported anxiety symptoms. Measured by Spence Children's Anxiety Scale Child Report Short (SCAS-C-8)
timeFrame: Baseline
measure: Baseline children's reported anxiety symptoms. Measured by Spence Children's Anxiety Scale Child Report Short (SCAS-C-8)
timeFrame: Immediately after the intervention
measure: Baseline children's reported anxiety symptoms. Measured by Spence Children's Anxiety Scale Child Report Short (SCAS-C-8)
timeFrame: 6 months after the intervention
measure: Baseline children's reported anxiety symptoms. Measured by Spence Children's Anxiety Scale Child Report Short (SCAS-C-8)
timeFrame: 12 months after the intervention
measure: Measured by Mood and Feelings Questionnaire - Short Version (MFQS)
timeFrame: Baseline
measure: Measured by Mood and Feelings Questionnaire - Short Version (MFQS)
timeFrame: Immediately after the intervention
measure: Measured by Mood and Feelings Questionnaire - Short Version (MFQS)
timeFrame: 6 months after the intervention
measure: Measured by Mood and Feelings Questionnaire - Short Version (MFQS)
timeFrame: 12 months after the intervention
measure: Baseline level of physical and emotional well-being reported by children as measured by the KidKINDL_children questionnaire.
timeFrame: Baseline
measure: Level of physical and emotional well-being reported by children as measured by the KidKINDL_children questionnaire.
timeFrame: Immediately after the intervention
measure: Level of physical and emotional well-being reported by children as measured by the KidKINDL_children questionnaire.
timeFrame: 6 months after the intervention
measure: Level of physical and emotional well-being reported by children as measured by the KidKINDL_children questionnaire.
timeFrame: 12 months after the intervention
measure: Self-Concept Form 5 (AF-5)
timeFrame: Baseline
measure: Self-Concept Form 5 (AF-5)
timeFrame: Immediately after the intervention
measure: Self-Concept Form 5 (AF-5)
timeFrame: 6 months after the intervention
measure: Self-Concept Form 5 (AF-5)
timeFrame: 12 months after the intervention
Secondary outcomes:
measure: The Child-Adolescent Perfectionism Scale (CAPS-S)
timeFrame: Baseline
measure: The Child-Adolescent Perfectionism Scale (CAPS-S)
timeFrame: Immediately after the intervention
measure: The Child-Adolescent Perfectionism Scale (CAPS-S)
timeFrame: 6 months after the intervention
measure: The Child-Adolescent Perfectionism Scale (CAPS-S)
timeFrame: 12 months after the intervention
measure: Baseline level of physical and emotional well-being reported by parents as measured by the Kid_KiddoKINDL-R questionnaire
timeFrame: Baseline
measure: Level of physical and emotional well-being reported by parents immediately after the intervention measured by the Kid_KiddoKINDL-R questionnaire
timeFrame: Immediately after the intervention
measure: Level of physical and emotional well-being reported by parents 6 months after the intervention measured by the Kid_KiddoKINDL-R questionnaire
timeFrame: 6 months after the intervention
measure: . Level of physical and emotional well-being reported by parents at 12 months measured by the Kid_KiddoKINDL-R questionnaire
timeFrame: 12 months after the intervention
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Department of Health Psychology. Miguel Hernandez University of Elche
state: Alicante
Study officials:
affiliation: Miguel Hernadez University of Elche
name: Mireia Orgilés Amorós, professor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.