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DepressionLTP+DadsNCT03564847

Learning Through Play (LTP) Plus Intervention for Depressed Fathers (LTP Plus Dads)

A study testing LTP Plus in people with Depression, run by Pakistan Institute of Living and Learning at 2 sites in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the study is to evaluate the clinical and cost effectiveness of culturally adapted group parenting intervention delivered by non-specialists and community health workers for depressed fathers. Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Depression
What is being tested?
LTP Plus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
357 participants
Where
2 sitesPakistan
Study dates
1 Jun 2018to 30 Nov 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 18 to 55 years old fathers
  • Having children aged between 0-30 months
  • Diagnosis of major depressive disorder using the Structure Clinical Interview for DSM-V,
  • Ability to complete a baseline assessment.
  • Given written informed consent

Who cannot join

  • Any medical illness that will prevent them from participation in the clinical trial,
  • Current or past diagnosis of bipolar depression
  • Currently using antidepressants or receiving any kind of psychotherapy
  • Active suicidal ideation,
  • Any other severe physical or mental disorders

Trial locations and contacts

2 sites in 1 country.

Pakistan2 sites
  • Bin Qasim Town

    Karachi, Sindh

  • Orangi Town

    Karachi, Sindh

Other trials in Pakistan

About this study

Official title: Testing Low-cost Learning Through Play (LTP) Plus Parenting Intervention for Depressed Fathers (LTP Plus Dads) A Cluster Randomized Controlled Trial (RCT)

The aim of the study is to evaluate the clinical and cost effectiveness of culturally adapted group parenting intervention delivered by non-specialists and community health workers for depressed fathers.

Read the detailed description

Most research on the association between parental depression and child outcomes has focused mainly on mothers. However, studies suggest that the relationship between parental depression and child outcome is not necessarily limited to mothers.

The study has two phases quantitative and qualitative:

Purpose of this quantitative phase is to determine if the LTP plus programme delivered by non-specialists and community health workers reduces symptoms of paternal depression and improves child development compared to treatment as usual.

In the qualitative part of the study focus groups and in-depth digitally recorded interviews will be conducted with participants by trained research staff at two-time points both before and after the intervention. These focus groups and in-depth interviews will continue till the data saturation is achieved. In addition, Participants who refused to participate in the trial will be asked if they would be willing to be contacted by a researcher to discuss their reasons for not taking part. Moreover, in-depth digitally-recorded interviews with stakeholders (grandparents, therapists, health professionals, etc) will also be conducted by trained researchers.

Conditions
Depression
Being tested
LTP Plus
Keywords
Learning Through Play Plus, Cognitive Behavior Therapy, Parenting Intervention, Low and middle-income country
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LTP PlusBehavioural

    LTP+Dads is a 12 - session group integrated parenting intervention: i.e LTP (Learning through Play) which includes a pictorial calendar, consisting of stages of child development from birth to 3 years. It includes parent-child play and other activities that promote parental involvement, learning, and attachment. In each stage, there are five areas of child development: sense of self, physical, relationships, understanding, and communication. All areas are written in simple, low-literacy language.

    Second component of intervention is CBT adapted from Jeanne Miranda manual (Group CBT for Depression, group leaders guide book-2006) focusing on the three areas: thoughts and your mood, activities and your mood, people interaction and your mood.

    Third component of intervention is content taken from Ed Bader's manual (Focus on Fathers) includes importance of fathers in child development, stress management at work and home, budgeting, anger management, conflict resolution and time management.

Study groups in NCT03564847
Study groupRoleWhat they receive
LTP PlusExperimentalLTP Plus Participants will receive the intervention over 4 months Weekly sessions for 2 months and fortnightly for next two months by trained non-specialists/community health workers.
Receives: Behavioral: LTP Plus
Treatment As Usual (TAU)No interventionTreatment as Usual (TAU) group will receive routine care and their follow up will be done at 4th and 6th month post randomization.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hamilton Depression Scale HAM-D 17 (Hamilton, 1960)

    The questionnaire is designed for adults and is used to rate the severity of their depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. The HAM-D is a simple 17 item self-report questionnaire can also be administered by a trained research worker. The translated version of the scale has been used in previous studies in Pakistan (Husain et al., 2017). It takes about 10 to 15 minutes to administer this scale. A score of 0-7 indicates normal, 8-13 mild depression, 14-18 moderate depression, 19-22 severe depression and > 22 severe depression

    Measured: Changes from Baseline to 4th and 6th Month

Secondary outcomes (21)
  1. Generalized Anxiety Disorder (GAD) 7 (Spitzer, Kroenke, Williams, & Löwe, 2006):

    The GAD-7 is a 7-item scale used to screen for and measure severity of generalized anxiety disorder. Scores of 5, 10 \& 15 are taken as cut-off points for mild, moderate and high. it takes about 5 minutes to administer this scale.

    Measured: Changes from Baseline to 4th and 6th Month

  2. Rosenberg's Self-Esteem Scale (Rosenberg, 1995)

    Rosenberg's Self-Esteem Scale will be used to measure self-esteem and personal worthlessness. It is a simple 9 item questionnaire. Higher scores indicate higher self-esteem. The Urdu translated version of scale has been used in our previous studies in Pakistan. (Husain et al 2014; Husain et al., 2017).The scale takes about 5 to 10 minutes to administer

    Measured: Changes from Baseline to 4th and 6th Month

  3. Brief Disability Questionnaire BDQ:(Von Korff, Ustun, Ormel, Kaplan, & Simon, 1996)

    BDQ is a simple 8 Items questionnaire to measure disability in the physical or social life. Total scores across items 1-6 are considered to indicate 'moderate' and 'severe' disability for score ranges 8-13 and 14-22 respectively. The translated version of scale has been used in previous trials in Pakistan (Naeem et al., 2015). It takes about 5 to 10 minutes to administer this scale

    Measured: Changes from Baseline to 4th and 6th Month

  4. Patient Health Questionnaire (PHQ-9) (Kroenke, Spitzer, & Williams, 2003)

    The Patient health Questionnaire (PHQ-9) is 10 items self-report questionnaire which is easy to use and can be administered by a trained research worker. Score ranges from : 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe

    Measured: Changes from Baseline to 4th and 6th Month

  5. Client Satisfaction Questionnaire (CSQ) (Attkisson & Greenfield, 1995)

    The participants will rate their satisfaction with the intervention at 4th month using the CSQ, it comprises of 8 items, high scores indicate greater satisfaction (Attkisson \& Greenfield, 1995). it takes about 5 minutes to administer this scale

    Measured: After completion of the intervention at 4th month only

  6. Parenting Scale (Arnold, O'leary, Wolff, & Acker, 1993)

    Parent-completed 30-item questionnaire measuring three dysfunctional discipline styles: (1) laxness (permissive discipline), (2) over-reactivity (authoritarian discipline) and (3) verbosity (reliance on talking), with responses rated on a seven-point scale. it takes about 10 minutes to administer this scale.

    Measured: Changes from Baseline to 4th and 6th Month

  7. Euro-Qol-5 Dimensions (EQ-5D) ( Brooks R. EuroQol,.1996)

    Health-related quality of life will be measured by using EQ-5D. This is a standardized instrument that measures five health dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), each scored from 1 to 3 indicating "no problem" to "severe problems". In both the visual analogue scale, and the standardized valuation score, lower scores indicate poorer QOL. It takes about 5 minutes to administer this scale.

    Measured: Changes from Baseline to 4th and 6th Month

  8. Hurt, Insulted, Threatened with Harm and Screamed (HITS) (Sherin, Sinacore, Li, Zitter, & Shakil, 1998):

    HITS is simple 4 item domestic violence screening tool. Each item is scored from 1-5. Range between 4-20. A score greater than 10 signify that an individual are at risk of domestic violence. It takes about 5 minutes to administer this scale. An adapted version of the scale is being used in this study.

    Measured: Changes from Baseline to 4th and 6th Month

  9. Dyadic Adjustment Scale (DAS):(Spanier, 1976)

    DAS is a 32 items self-report questionnaire, to measure couple satisfaction and to assess how each partner perceives his/her relationship. The scale has good psychometric properties (Graham, Liu, \& Jeziorski, 2006) and has also been used with depressed mothers (Wolman, Chalmers, Hofmeyr, \& Nikodem, 1993). A total DAS score, ranging from 0 to 150, is derived by summing across the four subscales. The 32 items of the DAS are answered on Likert-type scales with questions representing each of the four subscales distributed throughout.It takes about 10 to 15 minutes to administer. The culturally adapted version of the scale is being used in this study.

    Measured: Changes from Baseline to 4th and 6th Month

  10. Knowledge of Expectation and Child Development

    A 25-item questionnaire will be used to assess paternal knowledge and expectations for child development in the first three years. Higher score indicated higher knowledge about child development. (Husain et al 2017) .It takes about 5 to 10 minutes to administer this scale

    Measured: Changes from Baseline to 4th and 6th Month

  11. OSLO 3 (Nosikov & Gudex, 2003)

    Oslo-3 Items social support scale focuses on the quality of social network, perceived positive interest and concern from other people and available help from neighbors if necessary. A score of 3-8 is "poor support", 9-11 is "moderate support" and 12-14 is "strong support". The Urdu version of the scale has already been used in previous studies in Pakistan(Husain, Chaudhry, Jafri, et al., 2014). it takes about 5 minutes to administer this scale.

    Measured: Changes from Baseline to 4th and 6th Month

  12. Parenting Stress Index - Short Form (Abidin, 1995)

    Parents rate 36 items on a five-point rating scale (1-5) on three sub scales: (1) Parenting Distress, (2) Difficult Child Characteristics, and (3) Dysfunctional Parent-Child Interaction. it takes about 10 to 15 minutes to administer this scale.

    Measured: Changes from Baseline to 4th and 6th Month

  13. Eyberg Child Behaviour Inventory (ECBI) (Eyberg, Boggs, & Reynolds, 1980)

    The ECBI is a parent rating scale consisting of items relating specifically to behaviors associated with conduct problems in children. The ECBI is a behaviorally specific instrument consisting of a list of 36 behaviors. It has two scales: (a) The Intensity Scale, which indicates how often these behaviors occur, and (b) The Problem Scale, identifying which specific behaviors are considered as problems by the parents. Rating on intensity scale will be done on seven-point (1-7) whereas on problem scale with YES or NO. it takes about 10-15 minutes to administer this scale.

    Measured: Changes from Baseline to 4th and 6th Month

  14. Manchester Assessment of Caregiver-Infant Interaction (MACI)

    It is designed as a global rating measure, covering general features of parents, infant and dyadic qualities of interaction. It comprises of seven rating scales that covers broad aspects of interaction between a primary caregiver and their infant, each with a seven point scale (Wan, Brooks, Green, Abel, \& Elmadih, 2016). It is a method of systematically evaluating qualitative or global aspects of behavioural interaction between a primary caregiver and infant through rating their unstructured play from videotape. Ratings are made along a 7-point scale that show variance across the population Based on 6 minutes of caregiver-infant interaction videotaped in the lab or home.

    Measured: Changes from Baseline to 6th Month

  15. Anthropometric measures (Weight)

    Weight will be measured in Kilograms

    Measured: Changes from Baseline, to 4th and 6th Month

  16. Anthropometric measures (Height)

    Height will be measured in centimeters

    Measured: Changes from Baseline, to 4th and 6th Month

  17. Anthropometric measures (Head Circumference)

    The measurement swill be taken with a device that cannot be stretched, such as a flexible metal tape measure.

    Measured: Changes from Baseline, to 4th and 6th Month

  18. Anthropometric measures (Arm Circumference)

    The measurement swill be taken with a device that cannot be stretched, such as a flexible metal tape measure.

    Measured: Changes from Baseline, to 4th and 6th Month

  19. Ages and Stages Social-Emotional Questionnaire(Squires et al., 2009)

    This scale will be used to measure child development. Parents will report on their child's communication,gross motor, fine motor, problem solving and personal-social development. it takes about 10 minutes to administer this scale.

    Measured: Changes from Baseline to 4th and 6th Month

  20. Infant development: Ages and Stages Questionnaire (Squires, Bricker, & Twombly, 2009)

    This scale will be used to measure child development. Parents will report on their child's communication, gross motor, fine motor, problem solving and personal-social at different time points. it takes about 15 to 20 minutes to administer this scale

    Measured: Changes from Baseline to 4th and 6th Month

  21. Bayley Scales of Infant Development (BSID-V3) (Bayley, Nancy (2006

    The Bayley Scales of Infant and Toddler Development is a standard series of measurements originally developed by psychologist Nancy Bayley used primarily to assess the development of infants and toddlers, ages 1-42 months. Scoring: 0 or 1 depending on if the child is able to perform the activity for cognitive, motor(fine and gross subscales), and language(expressive and receptive subscales) scored by examiner. Social-emotional and adaptive questionnaires filled out by parent/caregiver with same scale 0 or 1. The highest possible score on a subtest is 19, and the lowest possible score is 1. Scores from 8 to 12 are considered average.

    Measured: Changes from Baseline to 6th Month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2018
  2. Study start1 Jun 2018
  3. Primary completion30 Nov 2019
  4. Study completion30 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
357 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03564847
Sponsor's protocol ID
PILL-LTP Plus Dads-002
Acronym
LTP+Dads
Status last verified
Oct 2020
First submitted
23 May 2018
Last updated
14 Oct 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Hasin DS, Goodwin RD, Stinson FS, Grant BF. Epidemiology of major depressive disorder: results from the National Epidemiologic Survey on Alcoholism and Related Conditions. Arch Gen Psychiatry. 2005 Oct;62(10):1097-106. doi: 10.1001/archpsyc.62.10.1097.

    PubMed 16203955
  • Hirschfeld RM, Montgomery SA, Keller MB, Kasper S, Schatzberg AF, Moller HJ, Healy D, Baldwin D, Humble M, Versiani M, Montenegro R, Bourgeois M. Social functioning in depression: a review. J Clin Psychiatry. 2000 Apr;61(4):268-75. doi: 10.4088/jcp.v61n0405.

    PubMed 10830147
  • Husain MI, Chaudhry IB, Husain N, Khoso AB, Rahman RR, Hamirani MM, Hodsoll J, Qurashi I, Deakin JF, Young AH. Minocycline as an adjunct for treatment-resistant depressive symptoms: A pilot randomised placebo-controlled trial. J Psychopharmacol. 2017 Sep;31(9):1166-1175. doi: 10.1177/0269881117724352. Epub 2017 Aug 31.

    PubMed 28857658
  • Husain N, Chaudhry I, Raza-ur-Rehman, Ahmed GR. Self-esteem and obsessive compulsive disorder. J Pak Med Assoc. 2014 Jan;64(1):64-8.

    PubMed 24605716
  • Husain N, Chaudhry N, Jafri F, Tomenson B, Surhand I, Mirza I, Chaudhry IB. Prevalence and risk factors for psychological distress and functional disability in urban Pakistan. WHO South East Asia J Public Health. 2014 Apr-Jun;3(2):144-153. doi: 10.4103/2224-3151.206730.

    PubMed 28607300
  • Husain N, Parveen A, Husain M, Saeed Q, Jafri F, Rahman R, Tomenson B, Chaudhry IB. Prevalence and psychosocial correlates of perinatal depression: a cohort study from urban Pakistan. Arch Womens Ment Health. 2011 Oct;14(5):395-403. doi: 10.1007/s00737-011-0233-3. Epub 2011 Sep 4.

    PubMed 21898171
  • Kane P, Garber J. The relations among depression in fathers, children's psychopathology, and father-child conflict: a meta-analysis. Clin Psychol Rev. 2004 Jul;24(3):339-60. doi: 10.1016/j.cpr.2004.03.004.

    PubMed 15245835
  • Kaufman J, Yang BZ, Douglas-Palumberi H, Houshyar S, Lipschitz D, Krystal JH, Gelernter J. Social supports and serotonin transporter gene moderate depression in maltreated children. Proc Natl Acad Sci U S A. 2004 Dec 7;101(49):17316-21. doi: 10.1073/pnas.0404376101. Epub 2004 Nov 24.

    PubMed 15563601
  • Klein DN, Lewinsohn PM, Rohde P, Seeley JR, Olino TM. Psychopathology in the adolescent and young adult offspring of a community sample of mothers and fathers with major depression. Psychol Med. 2005 Mar;35(3):353-65. doi: 10.1017/s0033291704003587.

    PubMed 15841871
  • Naeem F, Gul M, Irfan M, Munshi T, Asif A, Rashid S, Khan MN, Ghani S, Malik A, Aslam M, Farooq S, Husain N, Ayub M. Brief culturally adapted CBT (CaCBT) for depression: a randomized controlled trial from Pakistan. J Affect Disord. 2015 May 15;177:101-7. doi: 10.1016/j.jad.2015.02.012. Epub 2015 Feb 23.

    PubMed 25766269
  • Ramchandani P, Stein A, Evans J, O'Connor TG; ALSPAC study team. Paternal depression in the postnatal period and child development: a prospective population study. Lancet. 2005 Jun 25-Jul 1;365(9478):2201-5. doi: 10.1016/S0140-6736(05)66778-5.

    PubMed 15978928
  • Husain MI, Kiran T, Sattar R, Khoso AB, Wan MW, Singla DR, Umer M, Mangrio R, Bassett P, Chaudhry IB, Zafar SN, Jafri FA, Chaudhry N, Husain N. A Group Parenting Intervention for Male Postpartum Depression: A Cluster Randomized Clinical Trial. JAMA Psychiatry. 2025 Jan 1;82(1):22-30. doi: 10.1001/jamapsychiatry.2024.2752.

    PubMed 39356541

Questions about this trial

What is this clinical trial studying?

A study testing LTP Plus in people with Depression, run by Pakistan Institute of Living and Learning at 2 sites in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hamilton Depression Scale HAM-D 17 (Hamilton, 1960) (time frame: Changes from Baseline to 4th and 6th Month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03564847, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.

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LTP+Dads Clinical Trial NCT03564847 | AzTrials