This protocol conforms to guidelines presented in the Consolidated Standards of Reporting Trials (CONSORT) (33) 2010 statement extension for randomized feasibility studies and clinical trial protocols (see Additional file: Table S1). The intervention component is an uncontrolled open-label feasibility trial (hereafter referred to as ‘the intervention’), utilizing a pre-test–post-test within-subject design. The overall study design is illustrated in Fig. 1 (below), whereas the stages of the enrollment, interventions and assessments Table 1 below (The SPIRIT table).
Table 1. SPIRIT table for an uncontrolled open-label feasibility testing of Physical activity intervention: Confident Active and Happy Youth.
Intervention (CAH-Y)
The CAH-Y intervention includes two sessions of 50 min. per week, for seven weeks, in total 14 sessions. However, the final session is approximately 3 hours long since it includes a nature hike and a conclusion of the program. Several constraints shaped the possible length, intensity and overall dosage of the intervention. This delivery format is a compromise between evidence from behavior change research, organizational considerations and clinical considerations regarding the logistical and practical burden on youth and parents (time spent to commute to treatment, time away from school, etc.). Importantly, despite these constraints and consequently the compromises this entails on treatment format, the intended dose of physical activity within CAH-Y is still sufficient for the intended mechanisms to have effect (e.g. moderate to vigorous activity, inhibitory learning, building motivation, etc.).
The intervention is group-based with up to eight participants in each group. Two therapists lead each group. Groups are divided into a child group and an adolescent group to accommodate maturational differences. Youth aged 8-13 receive the child intervention, whereas youth aged 14-18 receive the adolescent version. Both versions follow the same format and structure and have the same guiding principles and goals. However, the specific activities in CAH-Y 13 and CAH-Y 18 are tailored to the meet the maturational level and interests of the different age groups.
Each session follows the same structure and format (with exception of the last session). This structure consists of, an introduction and warm-up (10 minutes), main activity (35 minutes) and a session wrap-up (5 minutes). The separate sessions have separate overarching topics and include a variety of activities. Sessions take place in a gymhall, two sessions involve activities in a swimming pool and the last session is outside.
Concerning the more specific physical activities in the intervention, sessions include a mix of aerobic (e.g. running, jumping, traversing an obstacle course), resistance (e.g. squats, push-ups) and relaxation exercises (e.g. yoga exercises). The goal for each session is a minimum of 30 min. spent in moderate to vigorous activity.
Specifically during the introduction and warm-up, the therapists give psychoeducation to the youth regarding the bidirectional interplay between thoughts, feelings, actions and particularly the role of avoidance and alternative coping strategies. The exercises are designed to stimulate some distress, fear and/or discomfort, and the therapists couple these feelings and reactions to the introductory psychoeducation, and use the exercises as exposure therapy. A supportive and mastery motivational climate facilitates the individuals need for relatedness (25) and a safe space to practice exposure (being observed), provides an optimal environment to help the youth address and overcome this fear (34). Thus, the group format allows youth to observe other youth, allowing them to observe that other youth have similar feelings, fears, reactions, behavior and responses as themselves, e.g. we sweat when we are physically active, trying out new activities may make us feel anxious but can be done nonetheless. Gaining this knowledge can help normalize the youth’s understanding of both themselves and others. Importantly, group and peer support are identified as an important intervention component to support active lifestyles (35, 36)
In accordance with self-determination theory, the sessions also strive to satisfy the youths’ needs for autonomy (e.g., giving them choices within a palette of activities to do), competence (e.g., adapting exercises to meet the needs/fitness levels of students), and relatedness (e.g., focusing on group cohesion, group cooperation). Importantly in this regard, the sessions do not have a competitive focus, but focus on being supportive, enjoyable and fun. An overview of the CAH-Y intervention is presented in Table 2.
Table 2. Description of the intended structure and format of Confident, Active and Happy Youth program.
Introduction
Session 1 – 2
|
Treatment stage
Session 3-12
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Closing and transitioning
Session 13 -14
|
Main Theme:
Alliance and motivation
Feeling secure in the group
Alliance to the group/therapist
Motivation to partake
|
Main Theme:
Challenge and exposure
Moderate to vigorous PA
From avoidance to exposure Strengthening motivation
|
Main Theme:
Transitioning to daily life
Active “lifestyle”
Continue exposure to PA
Motivation to continue
|
Week 1
2 sessions of 50 min.
|
Week 2-6
10 sessions of 50 min.
2 sessions weekly
|
Week 7
1 sessions of 50 min.
1 session of 3 hours
|
Notes: Pa: Physical activity.
Therapists
Group-leaders will have knowledge of mental health disorders, youth development, group-dynamics and physical activity to adequately understand and be able to meet the needs of the youth. Thus, a complementary team consisting of mental health nurse and a youth physiotherapist was recommended by the steering committee, to lead the intervention. Additionally, the need to be able to rapidly address and intervene if youths experience discomfort or need adjustments to activities while still instructing the other youth, mean that at least two therapists are needed.
Study population and eligibility
Youth are referred to the treatment program from their attending therapist at the local CAMHS. Youth can be included in the study if they meet the criteria below.
Inclusion criteria are:
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Age 8- 17 years
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Symptoms of anxiety and/or depression
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Youth display reduced daily physical activity (less than 30 mins. pr. day and/or does not partake in physical leisure activities, and/or does not participate in physical education in school).
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The youth is motivated to partake in physical activity
Exclusion criteria are:
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Physical activity is not advised for medical reasons
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Severe learning disabilities and the youth is unable to understand the study protocol
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Specific psychiatric disorders including any eating disorder, psychosis
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Severe challenging behavior or other needs requiring constant one to one support
Recruitment
Youth will be recruited from CAMHS, Department of Child and Adolescent Psychiatry, Haukeland University Hospital, Norway. CAMHS is organized at the same intervention level as ordinary hospital services (Haukeland University Hospital, Bergen, Norway) and is as such a tertiary specialized service. In the Norwegian context, this is the primary source of treatment for youth with mental health disorders. CAMHS is organized in three inpatient wards, three specialized clinics and seven outpatient clinics. These units together form the recruitment base for CAH-Y. CAMHS offers all forms of mental health services to youth in a catchment area of app. 460.000 citizens in total. The CAMHS receives app. 3000 referrals per year and delivers treatment to 5.2 % of all youth in the catchment area (37). Taking into account CAH-Y inclusion and exclusion criteria, we estimate that 40 % of these youth qualify for participation in the intervention (n = 600). The likely numbers of patients referred and eligible should greatly exceed the numbers required by the feasibility study, meaning well below 10 % of those eligible are required to consent.
Given that CAH-Y is organized within CAMHS, this enables easy access to potential participants and streamlined recruitment strategies. In practice, this translates into:
- uncomplicated dispersion of information regarding the intervention to the departments and mental health professionals via intranet, email and/or physical/digital meetings
- ease of implementing an in-house digital referral system
- a low threshold for communication between the CAH-Y team and the referring specialist
Based on the therapist’s assessment of eligibility and participant’s interest in the intervention, the therapist sends a formal referral to the CAH-Y team. The referrals are assessed with respect to inclusion/exclusion criteria by the Principle Investigator (PI is the first author). If the youth is assessed eligible, an invitation to attend a recruitment and inclusion interview is sent to the youth (and parents if the youth is below 16 years of age). Enclosed in the letter are also a number of health assessment questionnaires to fill out. The questionnaires assess mood, anxiety, demographic information and motivation to attend the intervention. Finally, this letter informs of a webpage address, where the participant can find more information about the intervention and the study. The referring specialist will receive notification that the youth is eligible and is invited to an interview. Approximately a week prior to the interview, youth/parents are contacted via phone and they are given further information about the intervention and study participation.
Consent
At the recruitment and inclusion interview, participants are provided further information about the intervention and the study, and any ensuing questions can be dealt with. Written information detailing the intervention, the study as well as the consent form are reviewed with the participant and/or parents if they participate in the interview. Informed written consent is obtained from all parents and assent is obtained from youth above age 12 years. All participants in the intervention fill out the same questionnaires, and go through the same assessment interview. Importantly, participation in the study requires written consent, but participation in the intervention is not dependent on participation in the study.
Withdrawal of the study participants
At any time, participants can withdraw consent with no consequences for further intervention participation or other eventual benefits. If there are any serious adverse events e.g. injury from the activities, details will be recorded and reported to the PI and to the work management group. CAMHS has appropriate insurance of the participants, if any adverse event should take place. In the case of adverse psychiatric effects are uncovered, this will be reported immediately to the participants referring specialist in CAMHS.
Feasibility procedures
After referral assessment of eligibility, eligible youth and their primary caregivers are invited to attend a recruitment and inclusion interview. This interview will take place in the CAH-Y facilities. In the interview, therapists will provide further information about the intervention and study details, clarifying any questions and/or concerns, obtaining written consent and they collect and check the questionnaires included in the invitation for the recruitment interview. Moreover, additional questionnaires will be filled out (see primary and secondary outcome measures section), medical information gathered (height and weight), participants will be provided an Actigraph activity monitor to be worn the next seven days and an activity diary to fill out. In addition, a short qualitative interview exploring participant and caregiver views on physical activity will be conducted. Finally, the youth and caregivers will be given a tour of the CAH-Y facilities in order to familiarize them with the setting.
The first session of the CAH-Y program will be between one to a maximum of three weeks after the interview. At this point, they will also return the Actigraph monitors and activity diaries. The intervention will then start. The day before every session, the participants will receive a SMS reminder of the session. After each session, participants are encouraged to visit a designated webpage for the program, where they can find further information about the next session. This is in order to remind the participants of the session clarify what is expected and encourage participation.
Following the last session of the intervention, participants will receive an invitation to attend a post-intervention interview, one to a maximum of three weeks following last intervention session. In this interview, questionnaires relating to symptom change will be completed, biometric data will be gathered and a short qualitative interview exploring the views of the participant and his/her caregivers in relation to the intervention will be done. At the end of the interview, participants will be provided an Actigraph activity monitor to be worn for the next seven days and a complementing activity diary. After these seven days have elapsed, a research assistant will gather the Actigraph. Independently of this assessment with the participant, a short qualitative interview with the referring specialist will also be conducted by the PI.
At six months post-intervention, the participants and their caregivers will be invited to attend a follow-up interview. In this interview, questionnaires relating to initial symptoms will be filled out anew, and a new short qualitative interview exploring views possible negative and/or positive effects of the intervention will be done. It the end of the interview, participants will be provided an Actigraph activity monitor to be worn for the next seven days and a complementing activity diary. After this time-period, the Actigraph will gathered by a research assistant. See Fig. 1 for study flow chart.
Comparison group
Participants will serve as their own controls. Pre- and post-treatment results will be compared.
Measures
Apart from the measures that participants and their caregivers fill out at home [SCAS, SMFQ, demographics], all other measures and assessments will be conducted in the CAH-Y facilities.
Socio-demographic characteristics and psychiatric conditions
Primary caregivers will provide socio-demographic information. The PI will acquire psychiatric/medical information, via the participant’s digital medical records. Axis-1 diagnoses are given during ordinary clinical practice by the youth’s psychiatrist or psychologist after reaching a consensus with other professionals from the multi-disciplinary team. In this study, we will classify the patients according to their main Axis I psychiatric diagnoses (ICD-10 codes are specified in Table 2) in the following groups: depressive disorders, anxiety disorders, hyperkinetic disorders, pervasive developmental disorders and other disorders (a broad spectrum of psychiatric disorders with low frequency). The assessment and diagnosis of youth in CAMHS will provide the necessary information in order to asses study eligibility according to the predetermined inclusion/exclusion criteria.
Feasibility outcomes
Feasibility of the trial will be done by way of continuous tracking of participant recruitment (number of youth referred/number of youth assessed as eligible), attendance and retention. The appropriateness, practicality and acceptability of the intervention within the CAMHS setting, will be explored through feedback from participants, primary caregivers and the referring specialists. This information will be gathered via semi-structured qualitative interviews, during the pre- and post-treatment assessment, while the referring specialists will be interviewed separately following the post-treatment assessment. Furthermore, the researchers will meet with the steering group at the end of the study to discuss the results and intervention acceptability.
Participant-centered outcome measures.
Objective measures of physical activity will be collected using the wearable activity sensor Actigraph GT3X+ monitor. The sensor captures and records continuous, high-resolution physical activity and sleep/wake information and can record daily time spent in sedentary, light and moderate to vigorous physical activity (MVPA). Other research has documented this method to be valid and reliable (38). Pre-defined minimum wear time for a valid day will be defined as 6 H/day with a minimum of 3 days of data required for analysis inclusion (39). Data for the Actigraph will be downloaded using Actigraph Actilife software and interpreted using 30 second epochs and the following cut-off points: sedentary (<100 cpm), MVPA (≥3200cpm) (40). Non-wear time will be defined as 60 minutes of consecutive zero counts. Participants will also be asked to wear the Actigraph during each intervention session to provide data on physical activity and MVPA content.
Participant height will be measured in meters and rounded to the nearest 0.1 cm. Weight will be measured in kilograms, and rounded to the nearest 0.1kg.
Anxiety symptoms will be assessed using Spence Child Anxiety Scale, child and parent version (SCAS-C/P) (Spence, 1998). The SCAS comprises 38 items rated on a 4-point scale (0 = never, 1 = sometimes, 2 = often, 3 = always), with a maximum score of 114. SCAS-C/P has demonstrated good psychometric qualities (41).
Affective symptoms will be assessed using Short Mood and Feelings Questionnaire, child and parent version (SMFQ-C/P) (Angold, Costello, Messer, & Pickles, 1995) is used to assess youth affective symptoms. The SMFQ has demonstrated good psychometric qualities (42).
Intervention motivation will be assessed using Nijmegen Motivation List Child (NML-C) (43) is used to assess treatment motivation in children and adolescents. The NML-C comprises 15 items rated on a 3-point scale.
The semi-structured qualitative interview will apart from feasibility outcomes also assess participant perceptions on PA in general, participant views on the association between PA and mental health, perceptions on the intervention components and the intervention as a whole, views on potential barriers to physical activity, motivation for activity and participation in school-based physical activity. These questions are posed at post-treatment and long-term follow-up. Caregivers are posed the same questions; however, caregivers to youth aged 12 years or above, will only receive these questions if the youth has consented to this. Answers to the questions are written down during the interviews and will be analysed by thematic analysis (44). An interview with the referring specialist, following the post-treatment interview with the participant, will similarly explore his/her experiences of the intervention including acceptability of procedures, perceived benefits and difficulties.
An effect-size will be calculated for youth and caregiver reported depression and anxiety symptoms and activity level. Means (M) and Standard deviations (SD) will be used to investigate the effect sizes for change between pre- to post-treatment. These results will help inform the power calculation of the likely required sample size for a future large-scale RCT.
Timing
Measures will be assessed at baseline (pre-intervention interview) and at the latest two weeks after completing the intervention. Follow-up outcome will be assessed six months post-intervention.
Sample size
As this will be the feasibility study to inform the design of the future definitive RCT, a target sample of 20 youth participants will be recruited for estimation of the intended variables (45).
Progression criteria
A feasibility studies is not adequately powered to test the any hypothesis (eg. the efficacy of CAH-Y physical activity intervention) but is set to improve the chances of conducting a high-quality RCT. Therefore, in line with suggestions by el-Kotob et al. (46) a priori criteria for progression to the definitive large-scale RCT is advisable to consider future efforts. The progression criteria to move on to a definitive large-scale RCT were A) no serious adverse events, such as hospitalization, a life-threatening condition, death and any adverse events associated with the intervention; B) recruitment rate of no less than 75 %; and C) retention rate of no less than 60% in each group at 7 weeks (total of 14 sessions). If all the three criteria are not met, we assess there is insufficient evidence to justify proceeding to the definitive RCT. Consequently, changes to the intervention would then be required with consequent re-runs of the intervention following, up until these criteria are met.
Statistics and data analysis
Quantitative data will be analyzed using SPSS version 22.0 for Windows (SPSS Inc., Chicago, IL).
Baseline data for participants will also be presented in charts as well as any possible participant missing data (questionnaires and Actigraph). Descriptive data will use 95% confidence intervals (mean and standard deviations). Baseline differences between groups (e.g. age, activity level, BMI, number of mental health disorders and questionnaire outcomes) will be analyzed using one-way ANOVA. Nominal data (e.g. gender, ethnicity, social class, participation in school physical activity) will be analyzed using Chi-square analyses. However, as mentioned the feasibility study is underpowered to detect any effects reliably. Thus, quantitative feasibility outcomes will be interpreted only as feasibility and pilot data due to lack of statistical power.
Qualitative interviews with participants, caregivers and referring specialists will be analyzed utilizing thematic analysis (44). Accordingly, the written interview data will be reviewed for data familiarization; initial codes will be generated, followed by organizing codes into themes, refining themes, and finally defining themes and sub-themes.
Possible harms
Potential harms of being involved in the intervention and the assessments will be explicitly outlined in the participant explanatory statements and consent form. During assessment, the primary potential risk for participants may be to experience some psychological distress; however, this is not anticipated to exceed levels of psychological distress experienced previously in CAMHS or in their daily lives. During the intervention, the youth are expected to engage in physical activity with varying degrees of activity intensity. During such activities, the youth could potentially injure themselves or others physically, and/or they could experience some physio-psychological distress. All activities required in the intervention are preplanned and will be completed so as be to be as safe as possible, yet any movement (in a group) does necessarily entail some risk of injury. All accidents and injuries will be recorded and reported to the PI and the work management group. In addition, any adverse events or mental states observed among the participants (e.g. significant symptom deterioration, suicidal ideation or suicid attempt, reported or observed abuse and/or self-harm, excessive weight loss etc.) will be monitored routinely throughout the study. Any such adverse events will be immediately reported back to the youth’s referring specialist, who is responsible for the youth’s mental health care. All study therapists and interviewers are experienced in working with youth with anxiety and depression and in responding to distress.