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An evaluation of a combined psychological and parenting intervention for HIV-positive women depressed in the perinatal period, to enhance child development and reduce maternal depression: Study Protocol for the Insika Yomama Cluster Randomised Controlled

South Africa, 2018 - 2023
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AHRI.Insika.Yomama.dataset
Producer(s)
Tamsen Rochat, Alan Stein, Samukelisiwe Dube, Kobus Herbst, Cecilia A. Hoegfeldt, Stephanie Redinger, Thandeka Khoza, Ruth Margret Bland, Linda Richter, Louise Linsell, Chris Desmond, Aisha K. Yousafzai, Michelle Craske, Ed Juszczak, Melanie Abas, Taygen Edwards, David Ekers
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Created on
Apr 10, 2026
Last modified
Apr 13, 2026
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Data file: AHRI.InsikaYomama.AssessmentWithoutVaccine.20241117

Cases: 320
Variables: 1246

Variables

post_24m_cbcl_31
Eats or drinks things that are not food do not include sweets
post_24m_cbcl_32
Fears certain animals, situations or places
post_24m_cbcl_33
Feelings are easily hurt
post_24m_cbcl_34
Gets hurt a lot, accident-prone
post_24m_cbcl_35
Gets in many fights
post_24m_cbcl_36
Gets into everything
post_24m_cbcl_37
Gets too upset when separated from parents
post_24m_cbcl_38
Has trouble getting to sleep
post_24m_cbcl_39
Headaches (without medical cause)
post_24m_cbcl_40
Hits others
post_24m_cbcl_41
Holds his/her breath
post_24m_cbcl_42
Hurts animals or people without meaning to
post_24m_cbcl_43
Looks unhappy without good reason
post_24m_cbcl_44
Angry moods
post_24m_cbcl_45
Nausea, feels sick (without medical cause)
post_24m_cbcl_46
Nervous movements or twitching
post_24m_cbcl_47
Nervous, highstrung, or tense
post_24m_cbcl_48
Nightmares
post_24m_cbcl_49
Overeating
post_24m_cbcl_50
Overtired
post_24m_cbcl_51
Shows panic for no good reason
post_24m_cbcl_52
Painful bowel movements (without medical cause)
post_24m_cbcl_53
Physically attacks people
post_24m_cbcl_54
Picks nose, skin, or other parts of body
post_24m_cbcl_55
Plays with own sex parts too much
post_24m_cbcl_56
Poorly coordinated or clumsy
post_24m_cbcl_57
Problems with eyes (without medical cause)
post_24m_cbcl_58
Punishment doesn't change his/her behaviour
post_24m_cbcl_59
Quickly shifts from one activity to another
post_24m_cbcl_60
Rashes or other skin problems (without medical cause)
post_24m_cbcl_61
Refuses to eat
post_24m_cbcl_62
Refuses to play active games
post_24m_cbcl_63
Repeatedly rocks head or body
post_24m_cbcl_64
Resists going to bed at night
post_24m_cbcl_65
Resists toilet training
post_24m_cbcl_66
Screams a lot
post_24m_cbcl_67
Seems unresponsive to affection
post_24m_cbcl_68
Self-conscious or easily embarrassed
post_24m_cbcl_69
Self-conscious or easily embarrassed
post_24m_cbcl_70
Shows little affection towards people
post_24m_cbcl_71
Shows little interest in things around him/hew
post_24m_cbcl_72
Shows too little fear of getting hurt
post_24m_cbcl_73
Too shy or timid
post_24m_cbcl_74
Sleeps less than most children during day and/or night
post_24m_cbcl_75
Smears or plays with bowel movements
post_24m_cbcl_76
Speech problem
post_24m_cbcl_77
Stares into space or seems preoccupied
post_24m_cbcl_78
Stomachaches or cramps (without medical cause)
post_24m_cbcl_79
Rapid shifts between sadness and excitement
post_24m_cbcl_80
Strange behaviour
post_24m_cbcl_81
Stubborn, sullen, or irritable
post_24m_cbcl_82
Sudden changes in mood or feelings
post_24m_cbcl_83
Sulks a lot
post_24m_cbcl_84
Talks or cries out in sleep
post_24m_cbcl_85
Temper tantrums or hot temper
post_24m_cbcl_86
Too concerned with neatness or cleanliness
post_24m_cbcl_87
Too fearful or anxious
post_24m_cbcl_88
Uncooperative
post_24m_cbcl_89
Underactive, slow moving, or lacks energy
post_24m_cbcl_90
Unhappy, sad or depressed
post_24m_cbcl_91
Unusually loud
post_24m_cbcl_92
Upset by new people or situations
post_24m_cbcl_93
Vomiting, throwing up (without medical cause)
post_24m_cbcl_94
Wakes up often at night
post_24m_cbcl_95
Wanders away
post_24m_cbcl_96
Wants a lot of attention
post_24m_cbcl_97
Whining
post_24m_cbcl_98
Withdrawn, doesn't get involved with others
post_24m_cbcl_99
Worries
post_24m_cbcl_100
Please write in any problems the child has that were not listed above
cbcl_date_collected_final
Date of CBCL data collection
cbcl_full_100items_eligible
CBCL Full Eligible - Was the full CBCL (100 questions) collected at the same tim
cbcl_ext_total_raw_score
Externalising CBCL - Total Raw Score
cbcl_ext_tscore_final
Externalising CBCL - T-score
cbcl_ext_percentile_final
Externalising Problems - Percentile
mnth24_prob_other
Are there any problems with the child has that were not listed above?
post_24m_ecd_resources_1
How many children's books or picture books do you have for [rthc_1] [wk_surname]
post_24m_ecd_resources_toys1
Homemade toys (such as dolls, cars or other toys made at home)?
post_24m_ecd_resources_toys3
Household objects (such as bowls or pots) or objects found outside (such as stic
post_24m_ecd_resources_toys2
Toys from a shop or manufactured toys?
post_24m_ecd_resources_care_1
In the last week, have you left your child alone for more than an hour?
post_24m_ecd_resources_care_2
If yes, on how many days in the past week did you leave your child alone for mor
post_24m_ecd_resources_care_3
In the last week, have you left your child in the care of another child (someone
post_24m_ecd_resources_care_4
If yes, on how many days in the past week did you leave your child in the care o
post_24m_ecd_resources_act_1___1
Read books to or look at picture books with the child? - Mother
post_24m_ecd_resources_act_1___2
Read books to or look at picture books with the child? - Father
post_24m_ecd_resources_act_1___3
Read books to or look at picture books with the child? - Someone
post_24m_ecd_resources_act_1___4
Read books to or look at picture books with the child? - None
post_24m_ecd_resources_act_2___1
Told stories to the child? - Mother
post_24m_ecd_resources_act_2___2
Told stories to the child? - Father
post_24m_ecd_resources_act_2___3
Told stories to the child? - Someone
post_24m_ecd_resources_act_2___4
Told stories to the child? - None
post_24m_ecd_resources_act_3___1
Sang songs to the child? - Mother
post_24m_ecd_resources_act_3___2
Sang songs to the child? - Father
post_24m_ecd_resources_act_3___3
Sang songs to the child? - Someone
post_24m_ecd_resources_act_3___4
Sang songs to the child? - None
post_24m_ecd_resources_act_4___1
Took the child outside the home, yard or enclosure? - Mother
post_24m_ecd_resources_act_4___2
Took the child outside the home, yard or enclosure? - Father
post_24m_ecd_resources_act_4___3
Took the child outside the home, yard or enclosure? - Someone
post_24m_ecd_resources_act_4___4
Took the child outside the home, yard or enclosure? - None
post_24m_ecd_resources_act_5___1
Played with the child? - Mother
post_24m_ecd_resources_act_5___2
Played with the child? - Father
post_24m_ecd_resources_act_5___3
Played with the child? - Someone
post_24m_ecd_resources_act_5___4
Played with the child? - None
post_24m_ecd_resources_act_6___1
Named, counted, or drew things with the child? - Mother
post_24m_ecd_resources_act_6___2
Named, counted, or drew things with the child? - Father
post_24m_ecd_resources_act_6___3
Named, counted, or drew things with the child? - Someone
post_24m_ecd_resources_act_6___4
Named, counted, or drew things with the child? - None
iy_bsid_c_31
31. Bell series: Rings bell purposely
iy_bsid_c_32
32. Looks at pictures
iy_bsid_c_33
33. Picks up block series: retains 2 of 3 blocks
iy_bsid_c_34
34. Searches for missing objects
iy_bsid_c_35
35. Takes blocks out of cup
iy_bsid_c_36
36. Block series: 1 block
iy_bsid_c_37
37. Picks up block series: 3 blocks
iy_bsid_c_38
38. Explores holes in pegboard
iy_bsid_c_39
39. Pushes car
iy_bsid_c_40
40. Finds hidden object
iy_bsid_c_41
41. Suspends rind
iy_bsid_c_42
42. Removes pellet
iy_bsid_c_43
43. Clear box: front
iy_bsid_c_44
44. Squeezes object
iy_bsid_c_45
45. Finds hidden objects (reversed)
iy_bsid_c_46
46. Removes lid from bottle
iy_bsid_c_47
47. Pegboard series: 2 holes
iy_bsid_c_48
48. Relational play (self)
iy_bsid_c_49
49. Pink board series (1 piece)
iy_bsid_c_50
50. Finds hidden objects (visible displacement)
iy_bsid_c_51
51. Blue board series (1 piece)
iy_bsid_c_52
52. Clear box: sides
iy_bsid_c_53
53. Relational play (others)
iy_bsid_c_54
54. Block series (9 blocks)
iy_bsid_c_55
55. Pegboard series: 6 pegs
iy_bsid_c_56
56. Pink board series (completes)
iy_bsid_c_57
57. Uses pencil to obtain object
iy_bsid_c_58
58. Blue board series (4 pieces)
iy_bsid_c_59
59. Attends to story
iy_bsid_c_60
60. Rotated pink board
iy_bsid_c_61
61. Object assembly (ball)
iy_bsid_c_62
62. Completes pegboard: 25 seconds
iy_bsid_c_63
63. Object assembly
iy_bsid_c_64
64. Matches pictures
iy_bsid_c_65
65. Representational play
iy_bsid_c_66
66. Blue board series (75 sec)
iy_bsid_c_67
67. Imitates a two-step action
iy_bsid_c_68
68. Matches 3 colours
iy_bsid_c_69
69. Imaginary play
iy_bsid_c_70
70. Understands concept of one
iy_bsid_c_71
71. Multischeme combination play
iy_bsid_c_72
72. Concept grouping: colour
iy_bsid_c_73
73. Concept grouping: size
iy_bsid_c_74
74. Compares masses
iy_bsid_c_75
75 . Matches size
iy_bsid_c_76
76.Discriminates pictures
iy_bsid_c_77
77. Simples pattern
iy_bsid_c_78
78. Sorts pegs by colour
iy_bsid_c_79
79. Counts (one-to-one)
iy_bsid_c_80
80. Discriminates sizes
iy_bsid_c_81
81. Identifies 3 incomplete picture
iy_bsid_c_82
82. Object assembly (dog)
iy_bsid_c_83
83. discriminates patterns
iy_bsid_c_84
84. Spatial memory
iy_bsid_c_85
85. Counts (cardinality)
iy_bsid_c_86
86. Number constancy
iy_bsid_c_87
87. Laces card
iy_bsid_c_88
88. Classifies objects
iy_bsid_c_89
89. Understands concept of more
iy_bsid_c_90
90. Repeats number sequences
iy_bsid_c_91
91. Completes patterns
iy_bsid_lr_13
13. Attends to other's play routine
iy_bsid_lr_14
14. Respond to request for social routines
iy_bsid_lr_15
15. Identifies object series: 1 correct
iy_bsid_lr_16
16. Identifes object in the environment
iy_bsid_lr_17
17. Identifies pictuer series: 1 correct
iy_bsid_lr_18
18. Understands inhibitory words
iy_bsid_lr_19
19. Identifies object series: 3 correct
iy_bsid_lr_20
20. Follows one-part directions
iy_bsid_lr_21
21. Identifies picture series: 3 correct
iy_bsid_lr_22
22. Identifies 3 clothing items
iy_bsid_lr_23
23. Identifies action picture serices: 1 correct
iy_bsid_lr_24
24. identifies 5 parts of the body
iy_bsid_lr_25
25. Follows two-part directions
iy_bsid_lr_26
26. Identifies action picture series: 3 correct
iy_bsid_lr_27
27. Understands use of objects
iy_bsid_lr_28
28. Understands part/whole relationships
iy_bsid_lr_29
29. Identifies action picture series: 5 correct
iy_bsid_lr_30
30. Understands pronouns (him, me, my, you, your)
iy_bsid_lr_31
31. Understands labels for sizes
iy_bsid_lr_32
32. Understands prepositions series: 2 correct
iy_bsid_lr_33
33. Understands possessives
iy_bsid_lr_34
34. Understands verb + ing
iy_bsid_lr_35
35. Identifies colours
iy_bsid_lr_36
36. Understands label of one
iy_bsid_lr_37
37. Understands pronouns (they, she, he)
iy_bsid_lr_38
38. Understands pronouns (his, her)
iy_bsid_lr_39
39. Understands plurals
iy_bsid_lr_40
40. Understands more
iy_bsid_lr_41
41. Understands most
iy_bsid_lr_42
42. Understands prepositions series: 4 correct
iy_bsid_lr_43
43. Understands negatives in sentences
iy_bsid_lr_44
44. Understands past tense
iy_bsid_lr_45
45. Understands labels for mass
iy_bsid_lr_46
46. Understands least
iy_bsid_lr_47
47. Understands less
iy_bsid_lr_48
48. Understands descriptive labels
iy_bsid_lr_49
49. Identieies categories of objects
iy_bsid_er_14
14. Uses one-word approximations
iy_bsid_er_15
15. Directs attention of other
iy_bsid_er_16
16. Imitates word
iy_bsid_er_17
17. Imitates play interaction
iy_bsid_er_18
18. Uses words appropriately series: 2 words
iy_bsid_er_19
19. Uses word to make wants known
iy_bsid_er_20
20. Names object series: 1 object
iy_bsid_er_21
21. Combines word and gesture
iy_bsid_er_22
22. Names picture series: 1 picture
iy_bsid_er_23
23. Uses words appropriately series: 8 words
iy_bsid_er_24
24. Answers yes or no verbally in response to questions
iy_bsid_er_25
25. Imitates a two-word utterance
iy_bsid_er_26
26. Uses a two-word utterance
iy_bsid_er_27
27. Names object series: 3 objects
iy_bsid_er_28
28. Names picture series: 5 pictures
iy_bsid_er_29
29. Uses multiple word utterances
iy_bsid_er_30
30. Uses pronouns
iy_bsid_er_31
31. Names ation picture series: 1 picture
iy_bsid_er_32
32. Poses multiple-word questions
iy_bsid_er_33
33. Makes a contingent utterance
iy_bsid_er_34
34. Uses verb + ing
iy_bsid_er_35
35. Names action picture series: 3 pictures
iy_bsid_er_36
36. Uses different word combinations
iy_bsid_er_37
37. Names action picture series: 5 pictures
iy_bsid_er_38
38. Uses plurals
iy_bsid_er_39
39. Answers what and where questions
iy_bsid_er_40
40. Uses possessives
iy_bsid_er_41
41. Names 4 colours
iy_bsid_er_42
42. Answers questions logically
iy_bsid_er_43
43. Tells how an object is used
iy_bsid_er_44
44. Uses prepositions
iy_bsid_er_45
45. Uses present progressive form
iy_bsid_er_46
46. Describes pictures series: Uses 4-5 word sentences
iy_bsid_er_47
47. Describes pictures series: Uses past tense
iy_bsid_er_48
48. Describes pictures series: Uses future tense
mnth24_unblinded_11b
I became unblinded
form11b_developdelay_previous
Developmental delay captured at previous assessments
form11b_disability_previous
Disability captured at previous assessments
form11b_prematurity
Is the child a premature baby (born before 36wk of gestation)?
form11b_diagnosis_child
Does the child have a known diagnosis
referral_child_bayley
Was the child referred?
p24m_ret_changes_reason
Reason for making changes
social_harm_date
Form completion date:
therapy_sh_feelings
Any problems with your feelings?
therapy_sh_confid
Any problems with the confidentiality of your status?
therapy_sh_fam
Any problems with your partner or your family?
therapy_sh_stigma
Any problems with stigma or harm in your community?
therapy_social_harm_det
If yes to any of the above, enter details:
sh_changes_reason
Reason for making changes
dm_screened_date
Date participant screened
dm_enrolled_date
Date enrolled into the trial
dm_delivered
Has the participant delivered ? (Only select "no" if the participant is still pr
infant_death
Did the participant experience infant death of the enrolled child?
theraphy_soc_calls
If yes, is the participant still accepting therapy/SoC calls?
assessment
If yes, is the participant still accepting assessments?
delivery_date
When did the participant deliver?
dm_6day_comment
Why did the participant miss the 6-day postnatal screener
dm_alt_dob_com
Please note any other information about the delivery that we know (gender, type
delivered
The participant has delivered ?
infant_gender
Was the delivery a boy or a girl (enrolled child if twins)?
delivery_type
Type of delivery Normal
team_informed_date
Date research team informed
child_dev_delays
Does the enrolled child have developmental delays or any similar issues (comment
child_dev_comments
Please explain briefly (also comment on whether the case is a reported AE/SAE):
trial_activities_relation
Are there any other things important to know about this participant in relation
trial_activities_comment
Please explain briefly
maternal_status_final
Final Maternal Status
child_status_final
Final Child Status
discontinuation_status_final
Discontinuation of therapy or ESoC (accepting assessments and completed final as
dm_difficult_to_reach
Is this participant difficult to reach?
dm_difficult_reach_date
From which date approximately was the participant difficult to reach?
dm_reach_track
Has this participant been tracked?
dm_potential_withdraw
Is this participant someone that should be discussed for a withdrawal?
dm_infant_disability
Does the enrolled infant have any major diseases or disabilities?
dm_delivery
Are there any important things to note about the delivery (e.g. delivered early)
dm_move
Has the participant moved outside the study area?
dm_other
Are there any important things to note about the mother/infant (e.g. working hou
dm_6day_miss
Did the participant miss the 6-day screener?
dm_6d_dob
When did the participant deliver? (also note the date if it was a stillbirth)
dm_violation
Did the participant experience a protocol violation?
dm_deviation_note
Did the participant experience a protocol deviation?
dm_posttrial_care
Did the participant receive any post-trial care after the 24m assessment?
pt_form_comp_date
Form completion date
pt_visit
Visit
pt_dob
What is the date of birth for your child (enrolled child)?
pt_mood_depression
Has the care you have received helped you with your mood/depression?
pt_self_esteem
Has the care you have received helped you feel better about yourself (increased
pt_practical_issues
Has the care you have received helped you with practical issues (for example, co
pt_baby_relationship
Has the care you have received helped you with your relationship with your baby?
pt_baby_development
Has the care you have received helped you know what you could do to help your ba
pt_baby_communication
Has care you have received helped you with understanding your baby's communicati
pt_feel_relaxed
Has the care you have received helped you with being able to feel relaxed?
pt_stressful_situation
Has the care you have received helped you cope with stressful situations?
pt_have_partner
Do you have a partner?
Total: 1246
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