Testing the Effectiveness of Supportive Parents - Coping Kids

Depressive Symptoms Clinical Trial

— SPARCK  

Official title:

A Randomized Controlled Effectiveness Trial of a Transdiagnostic Parent Training Intervention to Prevent Childhood Mental Health Problems in Norwegian Frontline Services

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05800522
• Other study ID #: 50708
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2023
• Est. completion date: June 2027

Study information

• Verified date: February 2023
• Source: Norwegian Center for Child Behavioral Development
• Contact: Line Ragna Aakre Karlson, MA
• Phone: +4790685479
• Email: l.r.a.karlsson[@]nubu.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

SPARCK is a novel transdiagnostic and preventive parent intervention targeting parents with children aged 4 to 12 years with elevated, yet subclinical, symptoms of anxiety, depression (internalizing) and/or behavioral problems (externalizing). In this project, investigators will conduct a randomized effectiveness trial with families randomized to SPARCK or regular care practices in the Norwegian frontline services, e.g. child welfare services, health services, and school health services. Investigators will study potential effects of SPARCK primarily on a) child symptoms when compared with regular care, and secondary on b) parenting practices, self-efficacy and stress, c) parent and child stress regulation as indexed by stress hormones (cortisol and DHEA) in hair, d) referrals to specialized services and CWS, and e) child and parent subjective quality of life. Additionally, Investigators will study facilitators and barriers to successful implementation and the relation between implementation and clinical outcomes.

Design: Two-armed parallel group randomized controlled trial. Families will be assessed at three time points: At pre intervention, at post (intervention termination), and at follow-up six months after post assessment. In cases were intervention exceeds 24 weeks, we will assess post at week 25. In such cases, follow-up will be assessed six months after week 25. Stress hormones will be collected at pre intervention and four weeks after intervention termination.

Despite a relatively heterogeneous target group, investigators expect a balanced design in terms of symptom domains and comorbidity across internalizing and externalizing symptoms. However, there is some uncertainty regarding the frequency of children with depressive symptoms exclusively (in contrast to symptoms of anxiety or behavioral problems). Our primary outcomes reflect the transdiagnostic feature of SPARCK; targeting anxiety, depression, and externalizing symptoms. Eligible children may display symptoms symptoms in ether one, two, or across all three symptom domains. Accordingly, investigators do only expect change in a relevant symptom domain if children display elevated levels at pre intervention.

Data will be inspected the data halfway through the data collection to monitor various issues, such as the distribution of symptoms of study families at intake and potential harm to study families. For instance, if children with depressive symptoms exclusively is low-frequent at intake, investigators may modify relevant hypotheses and accompanying primary outcome. An external researcher which is not part of the project will oversee the process.

To investigate the implementation part of the project, investigators will include a quantitative data gathering amongst SPARCK practitioners and their service leaders over three time points; intervention time point 1 (iT1; at project start), iT2 (after one year of data collection), and iT3 (after two years of data collection.).

Recruitment, analysis, and power: Participant recruitment in the effectiveness study will follow regular care procedures for screening and inclusion into the frontline services. Eligible families will be randomized within each site with a 50% chance of being allocated to control or intervention group. To promote predictability for the services in terms of intervention delivery, pairwise randomization within each site will be conducted. To prevent delay of intervention, and if an eligible second case match is not recruited within a four week period, a single block randomization will be done. Blocks are nested within each municipal site and the size of the block is blinded for study personnel and the sites. Randomization will be executed by an external provider, Klinforsk (www.klinforsk.no). The effect of the SPARCK vs. regular care will be indicated through a group (between) by time (within) interaction effect in a mixed effect repeated measures design. With an expected weak effect size of f =0.1, GPOWER 3.1 estimates the necessary n to detect group by time interaction with 80% power to be 164, but this is based on no design effects and no dropout. Assuming a therapist intraclass correlation of 0.08, with 4 cases per therapist, the design effect is 1.24, giving an effective n of 80% of the nominal n. Correcting for design effects and 20 % potential dropout the needed effective sample size is 252.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 252
• Est. completion date: June 2027
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Anxiety Symptoms
• Conduct Problems
• Depression
• Depressive Symptoms

Intervention

Behavioral:
• Behavioral parent or child directed intervention
Control 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
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.

Locations

Country	Name	City	State
Norway	National Center for Child Behavioral Development	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian Center for Child Behavioral Development	Kavli Trust

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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 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))
Other	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 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)
Other	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 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)
Other	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 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)
Other	Implementation Determinants measure	Practitioner and service leader reported 43-item measure to assess factors that can hinder or foster successful implementation of an intervention into a given context. The measure covers the CFIR domains Innovation (13 items), Outer setting (4 items), Inner setting (7), Individuals (6) and Implementation process (13), which includes several sub-themes/constructs (i.e. innovation relative advantage, innovation complexity, individuals attitudes, skills and motivation, external pressure, tension for change, implementation climate etc.). Items are measured on a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree).	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)
Other	SPARCK fidelity measure	SPARCK practitioner reporting intervention content used and client responsiveness	Weekly after each SPARCK session during the treatment period (until SPARCK treatment termination)
Other	Monitoring of control group intervention content.	Control group practitioner reports of intervention format, content and dosage.	Up to three times per case. At treatment start-up and at post treatment (up to 25 weeks). If treatment is not terminated after 25 weeks, at third assessment will be conducted after treatment is terminated.
Other	Change in parental psychological distress measured by Hopkins Symptom Checklist (SCL-10)	Parent reported 10-items instrument, assessed on 4-point Likert scales ranging between "not at all" and "extremly", tapping parents global perception of psychological distress	Pre (at respondent study inclusion), post (at treatment termination or up to 25 weeks), and follow-up (6 months after post assessment)
Other	Change in family accommodation measured by SPARCK accomodation items	14 parent reported items scored on 5-point Likert type scales tapping family accommodation to child problems during the last month.	Pre (at respondent study inclusion), post (at treatment termination or up to 25 weeks), and follow-up (6 months after post assessment)
Other	Changes in child routines measured by SPARCK child routines scale	Parent reported 3-items, assessed on 5-point Likert scales ranging between "strongly disagree" and "strongly agree", tapping occurrence of morning, meals and bedtime routines, and 4 items on numeric scales ranging between 1 and 4, tapping routine functioning.	Pre (at respondent study inclusion), post (at treatment termination or up to 25 weeks), and follow-up (6 months after post assessment)
Other	SPARCK client satisfaction	Parent reported 5-items constructed for this project, assessed on 5-point Likert scales ranging between "not correct" and "very correct", tapping client satisfaction.	Post (at treatment termination or up to 25 weeks)
Other	Working Alliance Inventory (WAI)	Parent reported 12-items instrument, assessed on 7-point Likert scales ranging between "never" and "always", tapping parent-client working alliance	Post (at treatment termination or up to 25 weeks)
Primary	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)
Primary	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	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.	Pre (at respondent study inclusion), post (at treatment termination or up to 25 weeks), and follow-up (6 months after post assessment)
Secondary	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	Pre (at respondent study inclusion), post (at treatment termination or up to 25 weeks), and follow-up (6 months after post assessment)
Secondary	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.	Pre (at respondent study inclusion), post (at treatment termination or up to 25 weeks), and follow-up (6 months after post assessment)
Secondary	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.	Pre (at respondent study inclusion), post (at treatment termination or up to 25 weeks), and follow-up (6 months after post assessment)
Secondary	Change in stress hormones cortisol and dehydroepiandrosterone (DHEA)	Collected from 2 cm hair samples collected from the primary caretaker and and target-child	Pre intervention (at respondent study inclusion and post intervention (4 weeks after treatment termination)
Secondary	Change in parent stress hormones cortisol and dehydroepiandrosterone (DHEA)	Collected from 2 cm hair samples collected from the primary caretaker	Pre intervention (at respondent study inclusion and post intervention (4 weeks after treatment termination)
Secondary	Change in child stress hormones cortisol and dehydroepiandrosterone (DHEA)	Collected from 2 cm hair samples collected from the target-child	Pre intervention (at respondent study inclusion and post intervention (4 weeks after treatment termination)
Secondary	Change in child subjective quality of life measured by Kid-KINDL	Child reported 24-times instrument, assessed on 5-point Likert scales ranging between "never" and "always", tapping children's perception on quality of life	Pre intervention (at respondent study inclusion and post intervention (4 weeks after treatment termination)
Secondary	Prevention of mental health and child protection service use	Register data on child referrals to specialist mental health services and contact with child protection services retrieved from Norwegian Patient Registry and Statistics Norway, respectively.	Two and five years after post intervention (treatment termination)
Secondary	Change in parental perceived life quality measured by Satisfaction With Life Scale (SWLS)	Parent reported 4-items instrument, assessed on 7-point Likert scales ranging between "strongly disagree" and "strongly agree", tapping parent's global perception of satisfaction with life.	Pre (at respondent study inclusion), post (at treatment termination or up to 25 weeks), and follow-up (6 months after post assessment)
Secondary	Change in tendency to school refusal measured by SPARCK school refusal scale	Parent reported 5-items constructed for the project, assessed on 5-point Likert scales ranging between "very rare" and "very often", tapping child school refusal behavior.	Pre (at respondent study inclusion), post (at treatment termination or up to 25 weeks), and follow-up (6 months after post assessment)