Evidence reports that parents with schizophrenia are particularly vulnerable to parenting difficulties and also experience problems in sensitively interacting with their children. This may cause insecure attachment in infants of mothers with psychosis. Children of parents with schizophrenia have poor developmental and clinical outcomes. However, there is no published trial, to the best of our knowledge, for children of parents with schizophrenia. Learning through Play (LTP) is a potentially low cost intervention to improve maternal mental health and child outcomes by promoting health child development. The proposed study will integrate LTP with existing culturally appropriate Cognitive Behaviour Theray (CBT) for psychosis (CaCBT-p) and test its feasibility and acceptability for parents with schizophrenia.
Objectives * To determine whether the proposed intervention is acceptable to the parents with schizophrenia. * To assess the feasibility of proposed intervention for target population (no of sessions attended, content, duration and location, uptake and retention). * To determine most suitable outcome measures for future randomized controlled trial. * To identify any barriers in recruitment of participants. Recruiting up to 75% of total sample will be a success criteria. Methods Design: Mixed method feasibility Randomised Controlled Trial Study Sites The participants will be recruited from outpatient departments of psychiatry and community settings in 7 cities of Pakistan i.e. Karachi, Hyderabad, Lahore, Rawalpindi, Multan, Peshawar and Quetta. Sample Size: A total of 90 individuals (45 in each arm) meeting the eligibility criteria will be recruited to participate in the study from different psychiatric units. Randomization Participants will be randomized into one of the two treatment conditions (LTP Plus or TAU) through computer generated algorithm.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
90
Combination of two interventions: Learning through Play and Cognitive Behaviour Therapy
Karwan e hayat
Karachi, Sindh, Pakistan
RECRUITINGRecruitment Rate
The number of parent-child dyads referred by the community health workers/treating psychiatrists, the parents who consented from all eligible parent-child dyads
Time frame: Change in numbers from first month of recruitment to last month of recruitment (total recruitment period is 12 months)
Attrition Rate
The number participants withdrawn out of those consented to participate
Time frame: Change in numbers from first month of randomisation to last month of outcome assessments (total time period is 18 months).
Intervention attendance log
This log will be maintained to assess the acceptability of the intervention is defined as "the extent participant receiving the intervention consider it to be appropriate"
Time frame: number of sessions attended by each participant in 12 month time
Positive and Negative Syndrome Scale
This is a structured clinical interview consisting of 30 items designed to assess severity of symptoms over the past week on a 7-point scale. Higher score indicates more severe psychopathology.
Time frame: Change in scores from baseline to 3-month post-randomisation
Psychotic Rating Scale
This scale rates features such as frequency, intensity, and interference of hallucinations and delusions on a 4-point scale. Higher score indicates more severe psychopathology.
Time frame: Change in scores from baseline to 3-month post-randomisation
Parenting Stress Index
This is a a five-point scale to assess (1) Parenting Distress, (2) Difficult Child Characteristics, and (3) Dysfunctional Parent-Child Interaction. Higher score indicates higher intensity of parenting stress.
Time frame: Change in scores from baseline to 3-month post-randomisation
Maternal Attachment Inventory
A 26-item scale will be used to ask respondents to indicate how they generally feel in relation to thoughts (e.g. 'My thoughts are full of my baby'), feelings (e.g. 'I feel love for my baby') and situations (e.g. 'I watch my baby sleep') new mothers may experience. Higer score indicate greater level of maternal attachment.
Time frame: Change in scores from baseline to 3-month post-randomisation
Knowledge attitude and practices of Child Development
A 20-item questionnaire will be used to assess maternal knowledge and expectations for child development in the first three years. Higher score indicate better knowledge about child development.
Time frame: Change in scores from baseline to 3-month post-randomisation
Calgary Depression Scale
This is a depression rating scale especially developed for assessing depression in schizophrenia. Higher scores indicate higher depressive symptom severity.
Time frame: Change in scores from baseline to 3-month post-randomisation
Social and Occupational Functioning Scale
It is a global rating of current functioning; this instrument focuses on social and occupational functioning that is independent of the overall severity of the individual's psychological symptoms. Higher score indicate better functioning.
Time frame: Change in scores from baseline to 3-month post-randomisation
Euro-Qol 5 Dimensions
A standardized tool assessing the five health related quality of life aspects such as mobility, self-care, typical activates, pain and discomfort and anxiety/depression. Higher score indicate better quality of life.
Time frame: Change in scores from baseline to 3-month post-randomisation
Client Service Receipt Inventory
this instrument is used to gather information about the complete spectrum of services and assistance that study participants might utilize
Time frame: Change in scores from baseline to 3-month post-randomisation
Ages and Stages Questionnaire
parent-reported screening instrument comprising of 25/29 items focusing social and emotional challenges, Higher score indicate better development.
Time frame: Change in scores from baseline to 3-month post-randomisation
Manchester Assessment of Caregiver-Infant Interaction
Six-minute videos of caregiver-infant interaction will be evaluated for a subset of participants by a trained, reliable rater on 7 MACI scales which globally assess core characteristics of caregiver-infant play interaction on a 7-point scale. Higher score indicate better interaction.
Time frame: Change in scores from baseline to 3-month post-randomisation
Bayley Scale of infant development
Bayley Scale will be administered on a subset of participants to assess the motor (fine and gross), language (receptive and expressive), and cognitive development of infant and toddlers, ages 0-3. Higher score indicate better development.
Time frame: Change in scores from baseline to 3-month post-randomisation
Child Height
Child height will be assessed in centimetres
Time frame: Change in scores from baseline to 3-month post-randomisation
Child Weight
Child weight will be assessed in KGs
Time frame: Change in scores from baseline to 3-month post-randomisation
Child head circumference
This will be assessed in centimetres
Time frame: Change in scores from baseline to 3-month post-randomisation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.