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

NCT02792894 | Completed DMC

• 1 other identifier: 746-05
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurodevelopmental Disorders; Developmental Disabilities

Keywords

cluster randomized trial; developmental delays; neurodevelopmental disorders; autism; intellectual disability; low resource settings; family volunteers

Outcome Measures

Primary Outcomes (1)

• 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).

  Change in DD-CDAS score at 6 months post-intervention

Secondary Outcomes (7)

• Caregiver-Child Interaction

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

• Strengths and Difficulties Questionnaire (SDQ)

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

• Family Empowerment Scale (FES)

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

• Inventory of Stigmatizing Experiences (Family version)

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

• Pediatric Quality of Life (PedsQL) family impact module

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

Study Arms (2)

Enhanced Usual Care (EUC)

NO INTERVENTION

Enhanced Usual Care comprises of normal routine visits conducted by the local community health workers / Lady Health Workers (LHWs). Care is enhanced in 2 ways: (a) LHWs in the EUC arm will receive training in identifying children with developmental disorders and delays, as well as making referrals to their primary care physicians for treatment using the WHO mhGAP training program for developmental disorders and (b) The primary care physicians will receive the training in WHO mental health GAP(mhGAP) program developmental disorders module, by WHO Collaborating Center in Rawalpindi, Pakistan.

Family Networks program

EXPERIMENTAL

Intervention 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).

Behavioral: Family networks program

Interventions

Family networks program BEHAVIORAL

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).

Family Networks program

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Human Development Research Foundation, Pakistan: lead
• Grand Challenges Canada: collaborator
• Autism Speaks: collaborator
• World Health Organization: collaborator
• Benazir Bhutto Hospital, Rawalpindi: collaborator
• University of Liverpool: collaborator

Study Sites (1)

Human Development Research Foundation

Gujar Khan, Punjab Province, Pakistan

Location

Related Publications (5)

• 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.

  PMID: 26598452 BACKGROUND

• 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.

  PMID: 24485093 BACKGROUND

• 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.

  PMID: 32913656 BACKGROUND

• 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.

  PMID: 29230307 BACKGROUND

• 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.

  PMID: 34059074 DERIVED

MeSH Terms

Conditions

Neurodevelopmental Disorders; Developmental Disabilities; Autistic Disorder; Intellectual Disability

Condition Hierarchy (Ancestors)

Mental Disorders; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Atif Rahman, PhD

  University of Liverpool

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 1, 2016
• First Posted: June 8, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: April 1, 2018
• Last Updated: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)