Sample
The research is being conducted within the LRH CAMHS in rural Victoria, Australia. The service provides care for children and adolescents across 40,000 square kilometres with a population of 236,000. All clinicians, employed full- or part-time within the LRH CAMHS, other than the principle investigator, are invited to participate. At the time of writing this includes 18 clinicians based at four sites. The clinicians comprise psychologists, social workers, occupational therapists, mental health nurses and a psychiatry registrar. The trial aims to include a minimum of 60 adolescent clients of LRH CAMHS, aged 12 to 18 years inclusive, to be recruited over 12 months. The sample size was determined on the basis of logistic feasibility and resource constraints. In addition, given the lack of information about the likely size of the intra-class correlation coefficient (ICC), one intention of this study is to estimate this statistic to assist in sample size calculation for a larger subsequent effectiveness trial [20].
Inclusion/Exclusion criteria
Adolescents are eligible to participate if (a) they meet the clinical cut-off for significant depressive symptomatology in the Reynold's Adolescent Depression Scale – 2nd Edition (RADS-2) (T ≥ 61) [21], or (b) receive a DSM-IV-TR [22] or ICD-10 [23] diagnosis of a depressive disorder (i.e. Major Depressive Disorder (MDD), Dysthymic Disorder, Depressive Disorder NOS, or Adjustment Disorder with Depressed Mood) as affirmed by the team psychiatrist, and (c) have a Children's Global Assessment Scale (CGAS) [22] of 65 or lower. Clients will need parental/guardian consent to participate and the agreement of the CAMHS consultant psychiatrist. Adolescents will not be included if they are actively suicidal, have a life-threatening condition, psychosis or schizophrenia. Parents/guardians are eligible to participate if their adolescent child is participating and they have no exclusion criteria.
Design
Approval for the research has been given by the Latrobe Regional Hospital (LRH) Human Research Ethics Committee (HREC) and the Monash University Standing Committee on Ethics in Research Involving Humans (SCERH).
Randomisation
A cluster randomisation design was chosen over simple client randomisation to overcome the obstacles of randomizing adolescents to treatment streams (i.e. to specific clinicians). Randomisation of adolescents could not be assured given limitations on the availability of specific clinicians at any given time and site.
The clinical assignment allocation process involves block randomisation of participating clinicians within each of the four sites to either IPT training or TAU. Allocation of clients to clinicians continues as per usual practice of availability. Randomisation was conducted centrally.
Treatments
The IPT stream comprises 12 weekly manual-based sessions with the adolescent. The TAU stream comprises usual care for the client. This may involve, for example, individual counseling, family work, liaison with schools and other professions, psychopharmacology, etc. In both streams the clinician will record monthly the treatment strategies used, the frequency of sessions, any additions or changes in medication, and any critical incidents which have occurred.
Concurrent process evaluation
Implementation issues will be investigated qualitatively using quarterly focus groups with clinicians and through individual telephone interviews with adolescent participants and their parent/guardians after receiving 12 weeks and 24 weeks of treatment. The telephone interviews with participating adolescents and parent/guardians will follow a semi-structured schedule to guide the interview. The questions will explore the participant's views on the treatment provided. Example questions include, 'How effective do you feel the treatment has been that you have received at CAMHS?', 'What have been the most helpful components of the treatment?' and 'What changes would you recommend in the treatment you have received at CAMHS?' The interview will take approximately 20 minutes.
A preliminary action research project was conducted with the LRH CAMHS clinicians to encourage clinician input and engagement in the design of the project. This comprised focus groups conducted with clinicians between three and five occasions during 2006. This process helped to shape the research to the clinical environment, and the clinical environment to research involvement.
Main outcome measures
Monitoring and outcome assessment will use reliable and valid measures applied in similar research. These include adolescent self-report, parent-report and clinician ratings:
1. Clinician-rated diagnostic status and clinical severity
a. Health of the National Outcome Scales (HoNOSCA) [24]. This is a global measure of child and adolescent mental health status. It is a standard CAMHS outcome measure used to rate changes in CAMHS client behaviour, impairment, symptoms, and social functioning.
b. CGAS [22]. The CGAS, presented in the DSM-IV-TR, is a clinician-rating scale (1 through 100) used rate the general functioning of children and adolescents.
c. Treatment Recording Sheet (TRS). This clinician-report record was adapted with CAMHS clinician input from the Hawaii Child and Adolescent Mental Health Division (CAMHD) Intervention Strategies Codesheet and Codebook [25]. It is a monthly record of specific intervention strategies used with an adolescent. It also records any critical incidents or medication changes occurring for the adolescent during that month. Its development is discussed elsewhere.
2. Self-report
a. RADS-2 [21]. This adolescent-report measure takes 5 to 10 minutes for an adolescent to complete and has a Grade 3 reading level. It is a screening measure for adolescent depression, providing a clinical cut-off for ratings of mild, moderate and severe depressive symptomatology as well as six critical items for clinical consideration. It shows good reliability and validity.
b. Strengths and Difficulties Questionnaire (SDQ-S) [26]. The SDQ-S is a standard outcome measure administered in CAMHS. It is a brief behavioural screening questionnaire for children and adolescents. It includes items related to emotional, conduct, and hyperactivity/inattention symptoms, peer problems and prosocial behaviour.
c. Multidimensional Adolescent Satisfaction Scale (MASS) [27]. The MASS is a 21-item scale measuring adolescents satisfaction with various dimensions of mental health service treatment. It has good reliability and demonstrated convergent, discriminate, and predictive validity. Its subscales include counselor qualities (perceived competence of the clinician and quality of the relationship), meeting needs (perceived adequacy of quantity and type of service received), effectiveness (perceived benefit of service), and counselor conflict (experience of negative interactions with counselor).
d. Client Satisfaction Questionnaire (CSQ-8) [28]. The 8-item CSQ-8 consists assesses overall level of satisfaction with the treatment received.
3. Parent-report
a. Strengths and Difficulties Questionnaire (SDQ-P) [26]. The SDQ-P is the parent-version of the SDQ, as described above
b. Short Mood and Feelings Questionnaire – Parent Version (SMFQ-P) [29]. The SMFQ-P is a 5 minute 13-item uni-dimensional parent-report measure of their child/adolescent's depressive symptomatology. It shows good internal reliability and discriminated between psychiatrically referred and non-referred children.
c. Client Satisfaction Questionnaire (CSQ-8) [28]. This measure is described above.
4. Other
Demographic details of clients. Age, gender, previous mental health treatment, medication, parental occupation, family members in home, and ethnicity were recorded.
5. Process evaluation
Evaluation questionnaires will be administered to all clinicians regarding use of the TRS at onset of research involvement and after 18 months. Evaluation of the IPT training will be conducted with IPT-trained clinicians immediately pre- and post-training and at 18 months follow-up. Focus groups conducted quarterly with clinicians will explore (a) contextual information regarding the research implementation (to assist interpretation of the quantitative trial results [19]), and (b) the feasibility, acceptability and sustainability of conducting the clinical research in CAMHS. Individual telephone interviews with adolescent participants and their parent/guardians will explore their satisfaction with treatment. Responses will be audio-tape recorded and transcribed.