Well-being intervention for adolescents in out patient psychiatric setting: A preliminary evaluation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- NIMHANS
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Score on Sterling Children’s Well-Being Scale
研究概览
简要总结
The current study aims at examining theeffect of the Well-Being intervention for adolescents attending follow upservices in Child and adolescent out-patient psychiatric setting. The primaryobjectives are to examine the effect of well-being intervention on emotionalwell-being of adolescents, on psychological well-being of adolescents and onadolescent’s functioning and to examine the feasibility of the well-beingintervention. The study design to achieve the aim is open label trial- singlegroup pre, post, follow-up design.
Well-being intervention refers to the Well-being therapy (WBT) forchildren and adolescents with emotional and behavioural disturbance by Albieriet al (2009) based on Ryff’s psychological well-being model with the aim ofimproving the emotional and psychological well-being of adolescents. The planof this study is to conduct 8 individual sessions of well-being intervention,based on the above model (online/ in person). This will be an adjunct to routine clinical care inthe follow-up.
Adolescents scoring CGI score of 4 or lessthan 4 in severity domain, CGAS score of 50-90 and who can converse and writein English/Tamil (Language restriction of researcher) will be included in thestudy. Clinical evidence of Mental retardation (F70-F79), Specificdevelopmental disorders of speech and language (F80), Specific developmentaldisorders of motor function (F82), Mixed specific developmental disorders (F83,Pervasive developmental disorders (F84), Other disorders of psychologicaldevelopment (F88) and Unspecified disorder of psychological development (F89),Adolescents who consumed alcohol/ any substances in last 3 months, disorderswith psychotic symptoms/ neurological disorders will be excluded from thestudy.
Repeated Measures ANOVA/ Friedman testwould be used to compare the means between follow up, post and pre interventionbased on the normality of the difference and homogeneity of variance betweenthe groups to check for the effect of intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 12.00 Year(s) 至 17.00 Year(s)（—）
- 性别
- All
入选标准
- •Adolescents, aged 12-17 years consulting CAP OPD, NIMHANS for follow up
- •Hyperkinetic disorders (F90), Conduct disorders (F91), Mixed disorders of conduct and emotions (F92), Emotional disorders with onset specific to childhood (F93), Disorders of social functioning with onset specific to childhood and adolescence (F94), Tic disorders (F95), Other behavioral and emotional disorders with onset usually occurring in childhood and adolescence (F96), unspecified mental disorder (F99), Mental disorders, not otherwise specified (F99)
- •Mania without psychotic symptoms (F30.1), bipolar affective disorder- current episode hypomania (F31.0), current episode mania without psychotic symptoms (F31.1), current episode mild or moderate depression (F31.3), current episode severe depression without psychotic symptoms (F31.4), current episode mixed (F31.6), mild depressive episode (F32.0), moderate depressive episode (F32.1), severe depressive episode without psychotic symptoms (F32.1), recurrent depressive disorder – mild (F33.0), moderate (F33.1), severe without psychotic symptoms (F33.2), cyclothymia (F34.0), Dysthymia (F34.1)
- •Neurotic, stress-related and somatoform disorders (F40-F48), Behavioral syndromes associated with physiological disturbance and physical factors (F50-F59)
- •CGI score of 4 or less than 4 in severity domain
- •CGAS score of 50 to 90
- •Participants who can converse and write in English/Tamil (Language restriction of researcher)
- •Accompanied by parent/s.
排除标准
- •Clinical evidence of
- •Mental retardation (F70-F79)
- •Specific developmental disorders of speech and language (F80), Specific developmental disorders of motor function (F82), Mixed specific developmental disorders (F83), Pervasive developmental disorders (F84), Other disorders of psychological development (F88) and Unspecified disorder of psychological development (F89)
- •Schizophrenia (F20)
- •Mania with psychotic symptoms (F30.2), Bipolar affective disorder, current episode mania with psychotic symptoms (F31.2), Bipolar affective disorder, current episode severe depression with psychotic symptoms (F31.5), Severe depression with psychotic symptoms (F32.3), recurrent depressive disorder, current episode severe with psychotic symptoms (F33.3)
- •Organic mental disorders (F00-F09) Adolescents with diagnosis of Substance Use Disorder who consumed alcohol/ any substances in last 3 months.
结局指标
主要结局
Score on Sterling Children’s Well-Being Scale
时间窗: pre assessment | post assessment | follow up after one month | follow up after three months
score on subjective Happiness Scale
时间窗: pre assessment | post assessment | follow up after one month | follow up after three months
score on Self-esteem scale
时间窗: pre assessment | post assessment | follow up after one month | follow up after three months
score on Functional status questionnaire
时间窗: pre assessment | post assessment | follow up after one month | follow up after three months
次要结局
- score on my experience scale(outcomes on changes in daily routine)