Testing the Effectiveness of Supportive Parents - Coping Kids

NCT05800522 | Recruiting

• 1 other identifier: 50708
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this clinical trial is to test the effectiveness of the parent training intervention Supportive Parents - Coping Kids (SPARCK) for prevention of childhood mental health problems. The main research questions are: • Is SPARCK effective in preventing and reducing negative outcomes and promoting positive outcomes for eligible children and parents compared with regular care practice? In addition, investigators will conduct an implementation study to examine relations between implementation determinants and implementation and clinical outcomes in the SPARCK intervention condition Participants in the effectiveness trial will be randomized to receive either the SPARCK intervention or active regular care practices provided by professionals in the Norwegian frontline services. Researchers will test the effectiveness of the SPARCK intervention at post treatment and six months follow-up.

Conditions

Conduct Problems; Anxiety Symptoms; Depressive Symptoms

Keywords

Transdiagnostic prevention; Childhood mental health problems; Parent training; Adaptive intervention

Outcome Measures

Primary Outcomes (2)

• Change in symptoms of child anxiety and depression measured by Revised Child Anxiety and Depression Scale

  Parent reported 47-items instrument tapping children's anxiety and depressive symptoms on a 4-point numeric scale ranging from 1 to 4. A higher score indicates more symptoms

  Pre (at respondent study inclusion), post (at treatment termination or up to 25 weeks), and follow-up (6 months after post assessment)

• Change in child problem behaviors measured by Eyberg Child Behavior Inventory

  Parent reported 36-items instrument tapping children's frequency of problem behaviors on a 7 point Likert-scale. Higher scores indicates more problem behavior.

  Pre (at respondent study inclusion), post (at treatment termination or up to 25 weeks), and follow-up (6 months after post assessment)

Secondary Outcomes (11)

• Change in child social and emotional problems measured by the Strengths and difficulties questionnaire (SDQ

  Pre (at respondent study inclusion), post (at treatment termination or up to 25 weeks), and follow-up (6 months after post assessment)

• Change in parenting practices measured by Parenting and Family Adjustment Scale (PAFAS)

  Pre (at respondent study inclusion), post (at treatment termination or up to 25 weeks), and follow-up (6 months after post assessment)

• Change in parental self-efficacy measured by Me as a Parent (MaaP)

  Pre (at respondent study inclusion), post (at treatment termination or up to 25 weeks), and follow-up (6 months after post assessment)

• Change in parenting stress measured by the Perceived Stress Scale

  Pre (at respondent study inclusion), post (at treatment termination or up to 25 weeks), and follow-up (6 months after post assessment)

• Change in stress hormones cortisol and dehydroepiandrosterone (DHEA)

  Pre intervention (at respondent study inclusion and post intervention (4 weeks after treatment termination)

Other Outcomes (12)

• Feasibility of Intervention Measure (FIM)

  Time 1 at project start (March 2023), time 2 after year 1 of data collection (March 2024), and time 3 when data collection is finished (2025))

• Acceptability of Intervention Measure (AIM)

  Time 1 at project start (March 2023), time 2 after year 1 of data collection (March 2024), and time 3 when data collection is finished (2025)

• Intervention Appropriateness Measure (IAM)

  Time 1 at project start (March 2023), time 2 after year 1 of data collection (March 2024), and time 3 when data collection is finished (2025)

Study Arms (2)

Control group

ACTIVE COMPARATOR

Various active treatments implemented in Norwegian frontline services. Treatments will include different measures varying in scope and intensity including eclectic counselling and other systematic and evidence-based interventions.

Behavioral: Behavioral parent or child directed intervention

Intervention group

EXPERIMENTAL

Transdiagnostic and preventive parent training intervention, Supportive parents - coping kids (SPARCK)

Behavioral: Supportive Parents - Coping Kids

Interventions

Behavioral parent or child directed intervention BEHAVIORAL

Control group will include different behavioral interventions that may include caretakers or the target child, and thus may vary in scope and intensity.

Control group

Supportive Parents - Coping Kids BEHAVIORAL

Intervention group will receive the transdiagnostic parent intervention (SPARCK). SPARCK is designed to include up to 12 sessions with caretakers. If necessary and applicable, children can attend sessions. The starting point for the development of SPARCK has been the Social Interaction Learning model, which represents the behavioral management perspective. In addition, SPARCK consists of empirically supported components based on attachment theory, emotion socialization, CBT, and family accommodation. Thus, content and strategies have been collected from different theories to provide a diverse toolkit tailored to address transdiagnostic problems in families with externalizing, internalizing, and caregiver challenges. SPARCK content and target strategies are tailored to the needs of the families and children, and the manual explains the content and how the target strategies may be tailored and combined.

Also known as: Parent training intervention

Intervention group

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children displaying elevated symptoms of internalizing or/and externalizing problems

You may not qualify if:

• Child is referred to or receives ongoing help in the specialized mental health services for problems in the internalizing or externalizing domains
• Child is diagnosed with psychosis, mental retardation or pervasive developmental disorder
• Acute suicide risk
• Documented or probable ongoing physical or sexual abuse
• Child or caretakers receives other systematic interventions targeting internalizing or externalizing problems while enrolled in the study (prior to 6 month follow-up)

Sponsors & Collaborators

• Norwegian Center for Child Behavioral Development: lead
• Kavli Trust: collaborator

Study Sites (1)

National Center for Child Behavioral Development

Oslo, Norway

RECRUITING

Related Publications (1)

• Gronlie AA, Backer-Grondahl A, Nes RB, Gomez MB, Tommeras T. Implementation of a parent training intervention (SPARCK) to prevent childhood mental health problems: study protocol for a pragmatic implementation trial in Norwegian municipalities. Trials. 2024 Dec 21;25(1):846. doi: 10.1186/s13063-024-08704-7.

  PMID: 39709458 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Truls Tømmerås, PhD

  National Center for Child Behavioral Development

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Line Ragna Aakre Karlson, MA

CONTACT

+4790685479; l.r.a.karlsson@nubu.no

Agathe Backer-Grøndahl, PhD

CONTACT

+4795211409; agathe.backer-grondahl@nubu.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are to be masked to what treatment condition they are assigned to, whether they receive the treatment or control condition. Treatment conditions are termed group 1 and group 2.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A two-armed parallel randomized effectiveness trial in Norwegian frontline services.

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: April 5, 2023
• Study Start: February 15, 2023
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 5, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)