Clinical trial NCT05760820: SES Children (SES Mini/SES Nxt) - A Digital Intervention for Children of Divorce
Official title: SES Children (SES Mini/SES Nxt) - A Digital Intervention for Children of Divorce
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parental Divorce
Parental Relationship Dissolution
Mental Health and Well-being
Keywords: Digital Intervention
Parental Divorce
Children age 3-17
Well-being
RCT Design
Quality of life
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Samarbejde efter Skilsmisse ApS
name: The Agency of Family Law
name: Aarhus Kommune
name: Aabenraa Kommune
name: Viborg Kommune
name: Rudersdal Kommune
name: Næstved Kommune
name: Lyngby-Taarbæk Kommune
name: Københavns Kommune
name: Hvidovre Kommune
name: Hillerød Kommune
name: Herlev Kommune
name: Gribskov Kommune
name: Greve Kommune
name: Glostrup Kommune
name: Gladsaxe Kommune
name: Furesø Kommune
name: Favrskov Kommune
name: Fredensborg Kommune
name: Horsholm Municipality
First posted: 2023-03-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention will be evaluated using a longitudinal ranodmized controlled trial study with a wait-list control design. Parents will be invited to the study and respond on behalf of children under the age of 11, while children aged 11 and older will respond to questions without parental assistance. Prior to baseline, parents (and all children of the parent) will be randomized (1:1) to either the intervention group (with access to the intervention) or the control group. Randomization will be blinded for participants only until the completion of the baseline questionnaire. All participants will be asked to complete questionnaires at 1- and 3-months post baseline. Those in the intervention group will gain immediate access to the digital intervention, while those in the control group will gain access after the 3-month follow-up questionnaire.
Primary purpose: TREATMENT

Brief summary: The overall aim of the SES Children (SES Mini/SES Nxt) - A Digital Intervention for Children of Divorce project is to develop the digital online intervention "SES Children (SES Mini \& SES Nxt)", and test whether it reduces well-known negative consequences of divorce and major life crises among children and adolescents by employing a longitudinal RCT study design. SES Children (SES Mini \& SES Nxt) is a digital intervention platform that seeks to develop the self-efficacy and ability of children to overcome the challenges that may come with a divorce and major life crises, thereby reducing the negative impacts of these on children's overall mental health and wellbeing. SES Children (SES Mini \& SES Nxt) is a first of its kind and differs from existing interventions aimed at children in four crucial ways: 1) by being a comprehensive online intervention accessible via PC, smartphone, and tablet; 2) by being research-based and developed with the ambition of later scientific testing of its effect; 3) by offering early intervention to all children who experience parental divorce - not just children experiencing problems or conflicts in connection with parental divorce or who belong to certain age groups, and; 4) through its format and design, the intervention is adaptive to the individual child's needs and age and focuses on establishing real and lasting self-efficacy and behavioral change rather than only being informative and psycho-educational. Thus, unique to the solution are also unique methodological advances and knowledge related to digital interventions for children.

Detailed description: The SES Children (SES Mini/SES Nxt) project consists of two main stages: 1) Development of the digital intervention, SES Children (SES Mini \& SES Nxt), and 2) Testing the intervention.

Stage 1: The digital intervention has been developed. The content of the intervention is based on the research in child psychology and the factors suggested to be central to children's mental health and well-being (e.g., agency, prosociality, connection, normalization, and mentalization) as well as on the experiences and needs of professionals in the field. Specifically, collaboration with the Agency of Family Law was established, and the agency is considered the primary stakeholder in the field. The material was digitally implemented by experts in the field of digital learning.

Stage 2: The aim of the second stage is to assess the efficacy of the intervention in improving children´s study's primary and secondary outcomes. The intervention will be tested using a mixed-method design, including both a quantitative and a qualitative study methodology. This will take place in collaboration with the Agency of Family Law and Danish municipalities. Specifically, families will be invited to participate in the study by e-mail through the Agency of Family Law, Danish municipalities, and social media outreach. Individuals will receive an invitation letter, containing a short explanation of the study and a link to the study website, which contains a more thorough information sheet, eligibility questions, and an consent form.

The intervention will be evaluated using a two-armed, online, longitudinal randomized controlled trial (RCT), comparing an intervention group and a waitlist control group. Prior to baseline, participants will be randomized (1:1) to either the intervention group or the control group. Randomization will occur at the family-level, such that all members of the same family (the parent and the children that are signed up for study participation) will be in the same group. All participants will be asked to complete questionnaires at study inclusion (baseline), and at 1- and 3-months post baseline. Parents will be asked to respond to baseline questions covering basic socio-demographic variables and the outcome questionnaire. Parents will respond on behalf of children under the age of 11 (that is, we will obtain parent-report on children aged 3-10), while children aged 11 and older will respond to questions without parental assistance, as specified in the manual instructions for the outcome measures. Randomization will be blinded for the participant only until after the completion of the baseline questionnaire. After completion of the baseline questionnaires, those in the intervention group will gain immediate access to the digital intervention, while those in the control group will gain access after the 3-month follow-up questionnaire. The qualitative part of the evaluation will be conducted using semi-structured interviews with children and parents; these interviews will occur after the 1-month follow-up questionnaire.

Eligibility criteria: Inclusion Criteria:

* be a custodial parent of at least one child between 3-17 year of age;
* be previously married and divorced or in a partnership and separated;
* have internet access;
* be able to write and read Danish.

Exclusion Criteria:

- not having a custodial child between 3-17 years of age.

Primary outcomes:
measure: Mental health and Well-being in Everyday Life - Emotional symptoms / problems
timeFrame: 3 months
measure: Mental health and Well-being in Everyday Life - Scale sum score
timeFrame: 3 months
measure: Mental health and Well-being in Everyday Life - Impact score
timeFrame: 3-months
Secondary outcomes:
measure: Mental health and Well-being in Everyday Life - Conduct problems
timeFrame: 3 months
measure: Mental health and Well-being in Everyday Life - Hyperactivity/inattention
timeFrame: 3 months
measure: Mental health and Well-being in Everyday Life - Peer relationships
timeFrame: 3 months
measure: Mental health and Well-being in Everyday Life - Prosocial Behavior
timeFrame: 3 months
measure: Quality of Life - The QoL VAS
timeFrame: 3 months
measure: Somatization
timeFrame: 3 months
measure: Body size perception
timeFrame: 3 months
measure: Sleep quality - difficulty falling asleep
timeFrame: 3-months
Other outcomes:
measure: Communicating needs
timeFrame: 3 months
measure: Setting boundaries
timeFrame: 3 months
measure: Connecting with an adult
timeFrame: 3 months
measure: School attendance
timeFrame: 3 months
measure: Parental Divorce Conflict
timeFrame: 3 months
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen
state: København K
Study officials:
affiliation: University of Copenhagen
name: Gert Martin Hald, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Copenhagen
name: Camilla S Øverup, PhD
role: PRINCIPAL_INVESTIGATOR
References: