Testing the Effectiveness of Supportive Parents - Coping Kids
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-12
SponsorNorwegian Center for Child Behavioral Development
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children displaying elevated symptoms of internalizing or/and externalizing problems
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Behavioral parent or child directed intervention
BehavioralControl group will include different behavioral interventions that may include caretakers or the target child, and thus may vary in scope and intensity.
Supportive Parents - Coping Kids
BehavioralIntervention 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.
Treatment groups
252 Participants
are divided into 2 treatment groupsGroup A: Control groupActive comparator 1 intervention
Group B: Intervention groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Pre (at respondent study inclusion), post (at treatment termination or up to 25 weeks), and follow-up (6 months after post assessment)2
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.
Time frame
Pre (at respondent study inclusion), post (at treatment termination or up to 25 weeks), and follow-up (6 months after post assessment)Secondary outcomes
1
Change in child social and emotional problems measured by the Strengths and difficulties questionnaire (SDQ
Parent reported 30-items instrument assessed on a 3-point numeric scale tapping children's internalizing and externalizing problems and prosocial skills. The 20-items total difficulties scale tapping composite internalizing and externalizing symptoms is used as primary outcome measure.
Time frame
Pre (at respondent study inclusion), post (at treatment termination or up to 25 weeks), and follow-up (6 months after post assessment)2
Change in parenting practices measured by Parenting and Family Adjustment Scale (PAFAS)
Parent reported 30-items instrument assessed on 4-point Likert scales ranging between "not at all" and "very much" tapping parenting skills and family relationships
Time frame
Pre (at respondent study inclusion), post (at treatment termination or up to 25 weeks), and follow-up (6 months after post assessment)3
Change in parental self-efficacy measured by Me as a Parent (MaaP)
Parent reported short-form 4-item instrument assessed on 5 point Likert scales ranging between strongly disagree and strongly agree tapping parental self-efficacy.
Time frame
Pre (at respondent study inclusion), post (at treatment termination or up to 25 weeks), and follow-up (6 months after post assessment)4
Change in parenting stress measured by the Perceived Stress Scale
Parent reported 10-items instrument, assessed on 5-point Likert scales ranging between "never" and "very often ", tapping parents global perception of subjective stress.
Time frame
Pre (at respondent study inclusion), post (at treatment termination or up to 25 weeks), and follow-up (6 months after post assessment)Other outcomes
1
Feasibility of Intervention Measure (FIM)
Practitioner and service leader reported 4-item scale (Weiner et al., 2017) that measures feasibility of an intervention, which is considered an implementation outcome indicating implementation success. Items are measured on a 5-point Likert scale from 1 (completely disagree) to 5 (completely agree).
Time frame
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))2
Acceptability of Intervention Measure (AIM)
Practitioner and service leader reported A 4-item scale (Weiner et al., 2017) that measures acceptability of an intervention, which is considered an implementation outcome indicating implementation success. Items are measured on a 5-point Likert scale from 1 (completely disagree) to 5 (completely agree).
Time frame
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)3
Intervention Appropriateness Measure (IAM)
Practitioner and service leader reported 4-item scale that measures appropriateness of an intervention, which is considered an implementation outcome indicating implementation success. Items are measured on a 5-point Likert scale from 1 (completely disagree) to 5 (completely agree).
Time frame
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)4
Organizational Readiness for Implementing Change (ORIC)
Practitioner and service leader reported 10-item instrument used to determine a collective level of organizational readiness for change, which is an important factor in successful implementation of new interventions, policies and practices. The measure consists of two subscales labelled Change Commitment (5 items) and Change Efficacy (5 items). Items are measured on a 5-point Likert scale from 1 (Disagree) to 5 (Agree).
Time frame
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Norwegian Center for Child Behavioral Development
Lead sponsor
Kavli Trust
Collaborator
Source ClinicalTrials.gov