Testing the Effectiveness of Supportive Parents - Coping Kids

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Conduct Problems, Anxiety Symptoms, Depressive Symptoms

Intervention / Treatment
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* Behavioral: Behavioral parent or child directed intervention
* Behavioral: Supportive Parents - Coping Kids


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A two-armed parallel randomized effectiveness trial in Norwegian frontline services.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>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<br>* Control group will include different behavioral interventions that may include caretakers or the target child, and thus may vary in scope and intensity.<br>|
| Experimental: Intervention group<br>Transdiagnostic and preventive parent training intervention, Supportive parents - coping kids (SPARCK) | Behavioral: Supportive Parents - Coping Kids<br>* 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.<br>* Other names: Parent training intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transdiagnostic prevention, Childhood mental health problems, Parent training, Adaptive intervention