Family Networks (FaNs) for Children With Developmental Disorders and Delays

Human Development Research Foundation, Pakistan540 enrolled

Overview

Over 6% of children in Pakistan suffer from a developmental disorder (intellectual disability or Autistic spectrum disorder) and most receive no intervention.In an earlier proof of concept study, the investigators integrated social, technological and business innovations to develop and successfully pilot a sustainable service for such children in one rural population of 30,000. Affected families were identified through a mobile phone-based interactive voice response system, and organised into family networks. 'Champion' family volunteers were trained in evidence-based interventions. A Tablet-based android application was developed for training, monitoring and supervision of the champions, based on the World Health Organization's guidelines. The champions delivered the intervention to other families in the network. The project was sustainable and demonstrated significant improvements in the lives of children and their families in the first 6 months of its operation. The investigators are scaling-up this intervention to a population of 1 million. The investigators aim to evaluate the effectiveness and cost effectiveness of the scaled-up programme using cluster randomized control trial nested within the scale-up study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

540

Conditions

Neurodevelopmental Disorders Developmental Disabilities

Interventions

Family networks programBEHAVIORAL

Intervention, Family networks Program (FaNs), is administered once weekly over 9-10 weeks in a group format over 3 hours per sessions. Family networks Program (FaNs) is based on WHO mhGAP module for developmental disorders and incorporates WHO parent skills training program for children with developmental disorders and delays. Parents Skills Training Program includes modules on communication, play, daily living skills, managing challenging behavior, coping with stress. Intervention is provided by the family volunteers (members of community, mostly women, who have a child affected in their families).

Eligibility

Sex: ALLMin age: 2 YearsMax age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Children aged between 2-12 years, * Screen positive on any of the Ten Questions screen questionnaire items # 1,4,5,7,8,9,10 for developmental disorders and delays. * Developmental disorder and delay present according to clinical assessment (History \& clinical examination for developmental delay in motor, communication, social, cognitive, daily living skills domains according to mhGAP developmental disorders guidelines for clinical assessment Exclusion Criteria: * Co-morbid physical or mental conditions in the child requiring inpatient hospitalization * Deafness or blindness in the child * Primary caregiver not available or unwilling to participate in the intervention program for 6 months * Physical or mental conditions in the primary caregiver needing inpatient hospitalization or frequent outpatient visits (more than two times a month) * Written consent not obtained for participation in the trial by the primary caregiver

Locations (1)

Human Development Research Foundation

Gujar Khan, Punjab Province, Pakistan

Outcomes

Primary Outcomes

Developmental Disorders- Children Disability Assessment Schedule (DD-CDAS)

The DD-CDAS is a 36-item questionnaire measuring functioning and disability. The 36 items are rated on a five-point Likert scale (1=none to 5=extreme/cannot do). The items represent cognition, mobility, self-care, getting along with others, life activities, and participation in the society. The raw scores are sum across all the items of each domain and all 36 items for a tool. Domain and total raw scores are transformed into a range from 0 to 100. The tool has been validated for children with developmental disorders in Pakistan (DD-CDAS) by our group (Hamdani et al, 2020).

Time frame: Change in DD-CDAS score at 6 months post-intervention

Secondary Outcomes

Caregiver-Child Interaction

Fifteen minutes video will be recorded to capture caregiver-child interaction. Caregivers will be asked to try home routines involving the child (e.g. feeding the child, performing domestic chores) or play based routines (e.g. playing with toys or reading a book) with their child. Caregiver's facilitators and interrupters (including child's engagement and distress during social communication) and joint engagement will be rated.

Time frame: Baseline (Pre treatment) and follow-up (6 months post-intervention)

Strengths and Difficulties Questionnaire (SDQ)

Parent rated, 25 items scale. Items are distributed over 5 domains: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior. Each item is rated on a 3-point Likert scale (0 = not true, 1 = somewhat true, 2 = certainly true). Total difficulty score is calculated by adding all the domain scores except prosocial problems.