SES Children (SES Mini/SES Nxt) - A Digital Intervention for Children of Divorce

NCT05760820 | Recruiting DMC

• 5 other identifiers: 504-0290/21-500022-B-01051045-00042B514-0699/22-30004956
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• Mental health and Well-being in Everyday Life - Emotional symptoms / problems

  Strength and Difficulty Questionnaire (SDQ) The Strength and Difficulty Questionnaire (SDQ), emotional symptoms subscale, is the primary outcome. The subscale consists of 5 items that are rated on a 3-point scale, with response options being "not true" (0), "somewhat true" (1), and "certainly true" (2). The score is obtained by summing (appropriately reverse-scored) items together; scores can range from 0 to 10. Higher subscales scores indicate greater problems. The scale has been validated and normed to Danish children and adolescents aged 2-17 and has been used in numerous Danish and international studies (see also http://sdq.dk).

  3 months

• Mental health and Well-being in Everyday Life - Scale sum score

  The Strength and Difficulty Questionnaire (SDQ) is used to assess mental health and well-being in everyday life among children and adolescents and has been found to be predictive of psychological and social functioning and (mal)adjustments in both the short term and in the longer run. The SDQ consists of 25 items that fall into five subscales: 1) Emotional symptoms, 2) Conduct problems, 3) Hyperactivity/inattention, 4) Peer relationships problem, and 5) Prosocial behavior. Items are rated on a 3-point scale, with response options being "not true" (0), "somewhat true" (1), and "certainly true" (2). A total difficulties score is generated by summing scores from all the scales except the prosocial scale. The resultant score ranges from 0 to 40, with higher score, indicating more mental health and well-being related difficulties. The scale has been validated and normed to Danish children and adolescents aged 2-17 and has been used in numerous Danish and international studies.

  3 months

• Mental health and Well-being in Everyday Life - Impact score

  The Strength and Difficulty Questionnaire (SDQ) is used to assess mental health and well-being in everyday life among children and adolescents. The SDQ contains an impact scale that assesses whether parents and children believe that the child has difficulties (in the areas of emotions, concentration, conduct, or social interactions), and if so, whether those difficulties interfere with the child's everyday life in terms of home life, friendships, classroom learning, and leisure activities. The impact supplement consists of 5 questions that are rated on a 4-point scale, with response options being "not at all" (0), "only a little" (0), "a medium amount" (1), and "a great deal" (2). The items are summed, and the resultant score can range from 0 to 10, with higher scores indicating greater impact of problems on daily life.

  3-months

Secondary Outcomes (8)

• Mental health and Well-being in Everyday Life - Conduct problems

  3 months

• Mental health and Well-being in Everyday Life - Hyperactivity/inattention

  3 months

• Mental health and Well-being in Everyday Life - Peer relationships

  3 months

• Mental health and Well-being in Everyday Life - Prosocial Behavior

  3 months

• Quality of Life - The QoL VAS

  3 months

Other Outcomes (5)

• Communicating needs

  3 months

• Setting boundaries

  3 months

• Connecting with an adult

  3 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

Access to the digital intervention post-baseline questionnaire and randomization.

Behavioral: SES Children (SES Mini & SES Nxt)

Control Group

NO INTERVENTION

Control group will gain access to the digital intervention after the 3-month follow-up.

Interventions

SES Children (SES Mini & SES Nxt) BEHAVIORAL

SES Children (SES Mini \& SES Nxt) is a digital intervention aiming to develop children's self-efficacy and ability to overcome the challenges that come with a divorce and major life crises, thereby reducing the negative impacts of these on children's overall mental health and wellbeing. The intervention formatted to specific age groups between the ages of 3 and 17, and is relevant to all children whose parents have split up, regardless of whether they experience a higher or lower degree of conflict between the parents, a or higher or lower degree of strain from the judicial divorce. The intervention covers a variety of topics, including "when my parents fight", "a bonus family", "packing the overnight bag", "to live in two places", and "children's rights".

Also known as: Samarbejde Efter Skilsmisse Children, Cooperation after Divorce Children

Intervention Group

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Copenhagen: lead
• Samarbejde efter Skilsmisse ApS: collaborator
• The Agency of Family Law: collaborator
• Aarhus Kommune: collaborator
• Aabenraa Kommune: collaborator
• Viborg Kommune: collaborator
• Rudersdal Kommune: collaborator
• Næstved Kommune: collaborator
• Lyngby-Taarbæk Kommune: collaborator
• Københavns Kommune: collaborator
• Hvidovre Kommune: collaborator
• Hillerød Kommune: collaborator
• Herlev Kommune: collaborator
• Gribskov Kommune: collaborator
• Greve Kommune: collaborator
• Glostrup Kommune: collaborator
• Gladsaxe Kommune: collaborator
• Furesø Kommune: collaborator
• Favrskov Kommune: collaborator
• Fredensborg Kommune: collaborator
• Horsholm Municipality: collaborator

Study Sites (1)

University of Copenhagen

Copenhagen, København K, 1014, Denmark

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Gert Martin Hald, PhD

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

• Camilla S Øverup, PhD

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gert Martin Hald, PhD

CONTACT

+4528731317; ghald@sund.ku.dk

Camilla S Øverup, PhD

CONTACT

+4535335174; camilla.oeverup@sund.ku.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: March 8, 2023
• Study Start: May 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2026
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)