Clinical trial NCT02792894: Family Networks (FaNs) for Children With Developmental Disorders and Delays
Official title: Evaluation of Family Networks (FaNs) for Children With Developmental Disorders and Delays Program: A Cluster Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurodevelopmental Disorders
Developmental Disabilities
Keywords: cluster randomized trial
developmental delays
neurodevelopmental disorders
autism
intellectual disability
low resource settings
family volunteers
Lead sponsor: Human Development Research Foundation, Pakistan
Sponsor class: OTHER
Collaborators: name: Grand Challenges Canada
name: Autism Speaks
name: World Health Organization
name: Institute of Psychiatry, Benazir Bhutto Hospital, Rawalpindi, Pakistan
name: University of Liverpool
First posted: 2016-06-08
Enrollment: 540
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Developmental Disorders- Children Disability Assessment Schedule (DD-CDAS)
timeFrame: Change in DD-CDAS score at 6 months post-intervention
Secondary outcomes:
measure: Caregiver-Child Interaction
timeFrame: Baseline (Pre treatment) and follow-up (6 months post-intervention)
measure: Strengths and Difficulties Questionnaire (SDQ)
timeFrame: Baseline (Pre treatment) and follow up (6 months post-intervention)
measure: Family Empowerment Scale (FES)
timeFrame: Baseline (Pre treatment) and follow up (6 months post-intervention)
measure: Inventory of Stigmatizing Experiences (Family version)
timeFrame: Baseline (Pre treatment) and follow up (6 months post-intervention)
measure: Pediatric Quality of Life (PedsQL) family impact module
timeFrame: Baseline (Pre treatment) and follow up (6 months post-intervention)
measure: Client Services Receipt Inventory (CSRI)
timeFrame: Baseline (Pre treatment) and follow up (6 months post-intervention)
measure: Clinical Global Impression (CGI)
timeFrame: Baseline (Pre treatment) and follow up (6 months post-intervention)
Other outcomes:
Locations:
city: Gujar Khan
country: Pakistan
facility: Human Development Research Foundation
state: Punjab
Study officials:
affiliation: University of Liverpool
name: Atif Rahman, PhD
role: STUDY_DIRECTOR
References:
citation: Hamdani SU, Minhas FA, Iqbal Z, Rahman A. Model for Service Delivery for Developmental Disorders in Low-Income Countries. Pediatrics. 2015 Dec;136(6):1166-72. doi: 10.1542/peds.2015-0861.
citation: Hamdani SU, Atif N, Tariq M, Minhas FA, Iqbal Z, Rahman A. Family networks to improve outcomes in children with intellectual and developmental disorders: a qualitative study. Int J Ment Health Syst. 2014 Feb 1;8(1):7. doi: 10.1186/1752-4458-8-7.
citation: Hamdani SU, Huma ZE, Wissow L, Rahman A, Gladstone M. Measuring functional disability in children with developmental disorders in low-resource settings: validation of Developmental Disorders-Children Disability Assessment Schedule (DD-CDAS) in rural Pakistan. Glob Ment Health (Camb). 2020 Jul 13;7:e17. doi: 10.1017/gmh.2020.10. eCollection 2020.
citation: Hamdani SU, Akhtar P, Zill-E-Huma, Nazir H, Minhas FA, Sikander S, Wang D, Servilli C, Rahman A. WHO Parents Skills Training (PST) programme for children with developmental disorders and delays delivered by Family Volunteers in rural Pakistan: study protocol for effectiveness implementation hybrid cluster randomized controlled trial. Glob Ment Health (Camb). 2017 Jun 13;4:e11. doi: 10.1017/gmh.2017.7. eCollection 2017.
citation: Hamdani SU, Huma ZE, Suleman N, Akhtar P, Nazir H, Masood A, Tariq M, Koukab A, Salomone E, Pacione L, Brown F, Shire S, Sikander S, Servili C, Wang D, Minhas FA, Rahman A. Effectiveness of a technology-assisted, family volunteers delivered, brief, multicomponent parents' skills training intervention for children with developmental disorders in rural Pakistan: a cluster randomized controlled trial. Int J Ment Health Syst. 2021 May 31;15(1):53. doi: 10.1186/s13033-021-00476-w.