An integrated Early Childhood Development intervention targeted at young children attending FAMI Centres in Colombia

An integrated Early Childhood Development intervention targeted at deprived young children in Colombia: a randomised controlled trial evaluation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN93757590

Enrollment

3200

Registered

2014-10-28

Start date

2014-09-01

Completion date

Unknown

Last updated

2018-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early childhood development (ECD)

Interventions

Community-based intervention to promote early childhood development in family-based parenting services. 96 clusters in total. 1. Treatment group: enhanced FAMI through psychosocial stimulation and nu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Children aged 0-12 months of age at baseline, attending FAMIs in 96 towns in rural and semi urban Colombia, by random assignment within the FAMI (preference will be given to children 0-6 months so that the can benefit from the intervention longer) 2. Pregnant women at baseline in the same FAMIs, by random assignment within the FAMI 3. Informed consent

Exclusion criteria

Exclusion criteria: 1. Children outside the 0-12 months of age range at baseline attending selected FAMIs (these children will be excluded from the study but will receive the intervention) 2. Children and pregnant women not attending selected FAMIs

Design outcomes

Primary

Measure	Time frame
Current primary outcome measures as of 18/04/2017: 1. Children's cognitive, receptive and expressive language and motor development, measured using the Bayley-III at follow-up (April-July 2016) 2. Children's socio emotional development, measured by ASQ test at follow-up (April-July 2016) 3. Children's height and weight, measured by assistant nurses in local community centers at baseline (August-November 2014) and follow-up (April-July 2016) 4. WHO motor milestones (the latter for children 6-12 months only), measured at baseline (August-November 2014) Previous primary outcome measures: 1. Children's cognitive, language, motor and socio-emotional development (possibly using the ASQ test, the MacArthur-Bates Child Development Inventories, and/or the Bayley-III), measured at follow up 2. Height and weight, measured at baseline and follow up (added 24/11/2015) 3. WHO motor milestones (the latter for children 6-12 months only), measured at baseline	—

Measure

Time frame

Current primary outcome measures as of 18/04/2017: 1. Children's cognitive, receptive and expressive language and motor development, measured using the Bayley-III at follow-up (April-July 2016) 2. Children's socio emotional development, measured by ASQ test at follow-up (April-July 2016) 3. Children's height and weight, measured by assistant nurses in local community centers at baseline (August-November 2014) and follow-up (April-July 2016) 4. WHO motor milestones (the latter for children 6-12 months only), measured at baseline (August-November 2014) Previous primary outcome measures: 1. Children's cognitive, language, motor and socio-emotional development (possibly using the ASQ test, the MacArthur-Bates Child Development Inventories, and/or the Bayley-III), measured at follow up 2. Height and weight, measured at baseline and follow up (added 24/11/2015) 3. WHO motor milestones (the latter for children 6-12 months only), measured at baseline

—

Secondary

Measure	Time frame
Current secondary outcome measures as of 18/04/2017: Measured at baseline (August-November 2014) and follow-up (April-July 2016): 1. Parenting practices and the level of stimulation in the home, measured using UNICEF’s Family Care Indicators (FCI) 1.1. No. of toy sources 1.2. No. of varieties of play materials 1.3. No. of varieties of play activities over past 3 days 1.4. No. of parental care activities over past 3 days 2. Use of verbal or physical abuse in the household, measured using UNICEF’s FCI 3. Parent knowledge about early childhood development, measured using a 10-item scale based on KIDI 4. Maternal self-efficacy, measured using the Caregiver Role Test – Modified 5. Mothers with depression symptoms, measured using Center for Epidemiologic Studies Depression Scale (CESD-10) 6. Maternal social support, measured using the DUKE UNC-11 scale 7. Variables of FAMI providers: activities developed in group sessions, collected through videos that are coded Previous secondary outcome measures: 1. Parenting practices and the level of stimulation in the home, possibly using the Family Care Indicators (FCI) 2. Activities developed by FAMI providers and knowledge of FAMI mothers on child rearing and development	—

Measure

Time frame

Current secondary outcome measures as of 18/04/2017: Measured at baseline (August-November 2014) and follow-up (April-July 2016): 1. Parenting practices and the level of stimulation in the home, measured using UNICEF’s Family Care Indicators (FCI) 1.1. No. of toy sources 1.2. No. of varieties of play materials 1.3. No. of varieties of play activities over past 3 days 1.4. No. of parental care activities over past 3 days 2. Use of verbal or physical abuse in the household, measured using UNICEF’s FCI 3. Parent knowledge about early childhood development, measured using a 10-item scale based on KIDI 4. Maternal self-efficacy, measured using the Caregiver Role Test – Modified 5. Mothers with depression symptoms, measured using Center for Epidemiologic Studies Depression Scale (CESD-10) 6. Maternal social support, measured using the DUKE UNC-11 scale 7. Variables of FAMI providers: activities developed in group sessions, collected through videos that are coded Previous secondary outcome measures: 1. Parenting practices and the level of stimulation in the home, possibly using the Family Care Indicators (FCI) 2. Activities developed by FAMI providers and knowledge of FAMI mothers on child rearing and development

—

Countries

Colombia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026